Face Mask Innovators

Face mask innovators need to step up their game. It looks like COVID-19 is going to be with us for a while. Rather than a temporary inconvenience, the wearing of face masks is becoming part of the new normal. An opportunity for better design has arisen because current masks fail in so many ways: Where [...]

Good Design is Good Business Strategy

Good design is good business strategy. Simply having stunning technology is not enough to achieve market success and sustained profitability. R&D might have developed a revolutionary innovation. But if you fail to package the innovation in a well-considered design that addresses both aesthetics and usability, you will leave a lot of money on the table. [...]

What Is Your Patent Worth?

You might have a patent for a medical device, but is it really worth anything? If you focused on the wrong things when you had the patent application drafted, it might not be worth much. At Forma, we are not patent attorneys. But we do work with clients to conceive and develop novel innovations. Sometimes [...]

Designing Medical Products for Home-Based Care

The transition from hospital-based care to home-based care has been going on for some time. The COVID-19 pandemic has sped that movement up considerably. As we continue to deal with the pandemic, medical products for home-based care will be increasingly needed. In addition to products and devices aimed specifically at COVID, solutions to enhance the [...]

Solving the Right Problem

Solving the right problem is dependent on being able to separate symptom from disease. A symptom is but a manifestation of the true problem that lies beneath. Addressing the symptom rather than the problem is the grand flaw most of us make when we’re confronted with a difficult challenge, whether in business or in our [...]

Covid-19: Crush the Curve

Covid-19: Crush the Curve: a summary from Ten Weeks to Crush the Curve, by Harvey V. Fineberg M.D., Ph.D. in the New England Journal of Medicine Establish a unified command: appoint a commander who reports directly to the President. Produce millions of diagnostic tests to test everyone with symptoms by mid-April. Supply all heath workers [...]

Speed-to-Exit: Why is it so important?

Rather than speed-to-market, “speed-to-exit” is the goal for many medical device inventors and the capital firms that back them. Commercializing a medical device requires a considerable time and resource commitment, as well as an above-average capacity to be tenacious. An easier route is to develop the technology to the point that it can be sold [...]

Proving Medical Device Feasibility

Proving medical device feasibility is the first important milestone in bringing a medical device to market. The bulk of device design and development can’t happen until feasibility has been proven. Read further to understand what feasibility means and what needs to happen before you can prove feasibility. The Process Medical device development starts with taking [...]

Uncovering Product and Market Opportunities

Uncovering product and market opportunities can be an added benefit of conducting a user research study. But only if the researchers and designers conducting the user study know how to look for them. Medical device user research is necessarily focused on the user interaction intricacies of the device itself. Paying attention to those interactions will [...]

10 Guidelines for Defining Medical Products

This week’s blog post on medical products comes courtesy of our good friend Joe Kalinowski, founder of Trilogy Associates. So, maybe you’re the second coming of Steve Jobs. You profess to know what folks will need, even though they don’t yet know they will want it. That approach to new-product definition is rarely successful. (Actually, [...]

Medical Device Usability and Cognitive Biases

Medical device usability is a top concern in medical design. There have been numerous studies that point to poor usability as contributing to medical errors. To design usability into medical devices, designers need to be aware of the many ways users (and they themselves) are influenced by biases in their thinking. I came across this [...]

What’s Ahead for 2019

We’re about to go into a new year. With that come predictions about what the year ahead will bring. From what I’ve been seeing, here are the areas that will be big in 2019: Artificial Intelligence (AI): AI has been in the news for a number of years now. 2019 could see the technology reach [...]

Medical Device Design and Usability

Usability is one of the most important aspects of medical device design. This paper from authors at the University of Cambridge cites a number of studies that have shown that a significant percentage of medical errors could be prevented if more attention had been paid in the design phase to the device’s usability. How easy a [...]

Medical Devices to Reduce Pain

Because of the opioid addiction epidemic in the US, there has been a push this year to encourage the development of non-addictive methods of reducing chronic and acute pain. SPR Therapeutics has an FDA-cleared device that does that. The SprintPNS (peripheral nerve stimulation) device consists of an electrical lead that is guided to its placement [...]

Design Helps the Bottom Line

Want to increase revenues by 32% and increase returns to shareholders by 56%? According to a study by McKinsey & Company, that is what you can achieve by investing in design. To come up with those measures, McKinsey analyzed 2 million pieces of financial data and 100,000 actions that companies took to deliberately make design [...]

Attack of the Microbots

Last week I wrote about research being done at Harvard to develop micro-scale soft robots. Well, just down the street from Harvard, MIT is working to develop robots that are the size of a single cell. But more than an advancement in robotics, the MIT effort is being touted as a breakthrough method of manufacturing [...]

Micro-scale Soft Robots

Medical robotics has been focused mainly on large, sophisticated systems that make surgery more efficient. Now we are seeing developments in tiny, soft robotic devices that could move around inside the body to perform various medically related tasks, from delivering drugs to a precisely targeted area to actually performing surgery. For example, Harvard’s Wyss institute [...]

The Ears Have It

Wearable devices have grown into a substantial consumer market. Yet their usefulness has not lived up to their hype. Most people give them up after about six months. No one has come up with functionality that is compelling enough to foster continued use of wearable devices. Once their novelty wears off, their use is abandoned. [...]

Touchscreens and Medical Devices

Touchscreens are becoming the predominant means of controlling devices of all kinds, including medical devices. It seems that more and more products are abandoning traditional hardware controls – push buttons, switches, sliders, knobs, etc. – for touchscreens. But current touchscreens have a serious drawback that makes them problematic to use and often frustrates the user. [...]

User Centered Design

Ease of use is a critical aspect of medical device design. A device that can be operated intuitively is a safer device – chances of use error are significantly reduced. A device that is simple to operate reduces the cognitive load of the user, allowing them to concentrate on the task, not on the device. [...]

Design of Wearable Medical Devices

There has been some interesting news on the design of wearable medical devices recently. Rutgers University is developing a wristband that can access the blood stream and draw up samples via a micron-sized tube. Sensors on the band can count blood cells, bacteria, organic matter and particles in the air, providing the capability to monitor and [...]

Radar to Detect Blood Glucose Levels

Scientists at the University of Waterloo are working on a device that would use radar to determine blood glucose levels. By analyzing how the electromagnetic waves sent by a radar transmitter bounce off of a glucose solution, the scientists were able to detect minute changes in the properties of solutions with different levels of glucose. [...]

Where Medical Imaging is Headed

Most medical imaging technologies in widespread use today provide relatively low-resolution, black and white, 2-dimensional images that require significant training to interpret and understand. However, new technologies are being developed that are going to revolutionize medical imaging, allowing 3-dimensional, color images to be obtained. Some of those technologies can even yield video images in real [...]

At-Home Diagnostics is Here

At-home diagnostics is about to have a major impact on healthcare systems world-wide. has just received FDA clearance to market their home diagnostic urinalysis system in the United States. It is already CE certified. For a simple explanation of the product, see this article in MedGadget. The website also has several excellent, short videos [...]

Electronic Bandages

Flexible, wearable devices are being developed that could act as electronic bandages. Engineering researchers at a number of universities are collaborating on a device that would both monitor how a wound was healing and deliver drugs to the wound site as needed. This is an application of cutting edge technology to a basic and pervasive [...]

Will Light be the Key to Curing Addiction?

Optogenetics is a tool that is being used extensively to learn how the brain works. In a study recently published in Nature, a research team was able to use optogenetic techniques to modify taste sensations in mice. By stimulating with light genetically altered areas of the brain, they were able to make the mice experience [...]

A Simple App to Encourage Behavior Change?

Medtronic and Nutrino  have partnered to offer the iPro2 myLog App that integrates with Medtronic’s iPro2 professional continuous glucose monitor (CGM). The app provides an easy way for diabetes patients to track the foods they consume – they simply take a picture of their meal. Artificial intelligence is used to analyze the food consumed and [...]

New Battery Technology?

The medical press is filled with breathless hype about the potential of new technologies. I am guilty of that myself. While there are a lot of very interesting things going on in science that could be employed in medical technology, the fact is that it takes a very long time before something proved to be [...]

Cell Processes Revealed

A new microscopy technique developed by a consortium of universities has enabled unprecedented imaging of processes occurring deep within living cell structures. The technique involves passing an ultra-thin sheet of light repeatedly through the target area, effectively creating slices of the target volume. A computer can stitch the image data captured to create a 3-dimensional [...]

Low cost, Flexible Electronic Body-Worn Monitors

Flexible electronics have significant potential for applications in medical devices. Still mostly in the developmental stages, I believe it will be very soon that we will see them in commercial products. According to an article in Medical Design Technology, a team at the University of Texas at Austin has developed a way to manufacture flexible [...]

More on Computer-augmented Imaging

I have written on numerous occasions about the fact that computer algorithms are being developed to enhance imagery from ultrasounds, MRI’s, CT scans and the like to provide far greater resolution and clarity. A recent story in Medical Device Technology reported that deep machine learning has been used to enhance images from smartphone cameras to [...]

Will Medical Devices Replace Pharmaceuticals?

To date, the wearables market has been focused on providing monitoring functionality – steps taken, heart rate, pulse, etc. In the future, wearable devices are also going to provide therapeutic remedy functionality. There are a number of companies that have recently come out with devices to treat various maladies that are normally addressed with pharmaceuticals. [...]

Algorithm-based Healthcare

Sonde Health contends that analysis of subtle changes in your voice can accurately reveal important aspects of your health. They are working to develop an algorithm that can be used to compare the vocal characteristics of an individual over time and use the data to develop correlates to mark the earliest onset of illness and [...]

Implanted Sensors

Sensors that can be implanted in the body will be replacing the current generation of wearable technology. Profusa, a company based in San Francisco, has developed a device that can be implanted under the skin and can serve as a sensor to determine levels of oxygen, carbon dioxide, glucose and lactate in the blood. What’s [...]

Structured Light

I have been writing for some time about the technological advances that are being made allowing us to harness the characteristics of light for a multitude of new uses. I’ve even described the 21st Century as being the Century of Light, because of the new discoveries that are being made and the potential those discoveries [...]

A Nanoscale Artificial Eye

The advances we are making in understanding the physics of the nano scale are truly amazing. The inventions that come from that understanding will be as disruptive – or more so – than were the internal combustion engine or the internet. An example of where we are heading can be seen in research that is [...]

Coming Soon, To Your Own Phone!

I have written in the past about non-invasive sensing to monitor health parameters. It appears that one such technology could soon go mainstream. Smartphone video cameras can capture the subtle changes in skin coloring that occurs as blood pulses underneath. GE Global Research – along with Michigan State University and the University of Rochester Medical [...]

Flexible Electronics Advance for Medical Devices

The technology surrounding flexible electronics is making considerable strides, with the latest news coming out of Stanford University. A team at Stanford has developed a system composed of layers of polymers that provide stretch-ability, electrical conductance and insulation. Importantly, the team has also developed a method to fabricate the material in production quantities. With 6000 [...]

Gamification of Rehab

I am not a big proponent of “gamification”, but The RAPAEL Smart Pegboard from Korean company, Neofect is one product for which it seems appropriate and would be effective. RAPAEL provides a versatile solution for physical therapists dealing with all kinds of rehabilitation patients. The board has three different templates that can be used – [...]

Rotational 3D Printing

3D Printing has been hyped for a long time as a game-changing manufacturing method. But its use is still limited mainly to the production of prototype parts. Using the technology for large-scale commercial manufacturing has proven difficult due to limitations of the physical properties (mostly strength) of the materials suitable to be 3D printed. It [...]

Artificial Muscle for Soft Robots

Material science and mechanical engineering researchers at Colorado University, Boulder, have developed a remarkable system that imitates the function of biological muscle. The devices are described as “hydraulically amplified self-healing electrostatic” actuators, or HASEL for short. They consist of a soft pouch – foil, elastomer, or other soft/flexible material – filled with electrically insulating liquid [...]

More on the Century of Light

I have been predicting that harnessing the characteristics of photons and light energy is going to be the source of many of the most significant innovations we will see in this century. More support for this observation comes from an article at, that discusses how light might replace electrons to create faster, smaller and [...]

The Physics of Future Medical Devices

Untangling the mysteries of quantum physics could have a huge impact on future medical devices. MIT Technology Review reports on a study out of the Federal University of ABC in Brazil in which researchers say they have been able to reverse the arrow of time. No, this isn’t a “Back to the Future” scenario. It [...]

Flexible Microfluidics for Medical Devices

A flexible microfluidic system is being developed in John Rogers' Lab at Northwestern University. Rogers, previously at University of Illinois – Champaign, is the leading pioneer in flexible electronics. The device under development uses wireless electronics, color sensors and silicone with microfluidic channels etched in. In the form of a flat patch, it attaches to [...]

Augmented Reality to Aid Surgery

Augmented reality has been a hot topic this year. Most of the emphasis at present seems to be in the consumer and entertainment area. However, the Fraunhofer Institute in Germany is experimenting with using augmented reality technology to aid in the surgical removal of cancerous lymph nodes. Cancers often spread first to the lymphatic system. [...]

Algorithms and Medical Imaging

Analytics 4 Life is a new company that is working on bringing a device to market that uses Phase Space Tomography to provide a new form of digital imaging for diagnostic purposes. Their initial focus is on coronary artery disease. Their CorVista system uses 7 sensors that attach to a patient’s chest and back. From [...]

Scientific Wellness

Scientific wellness is a term that Dr. Leroy Hood uses to describe where he thinks the future of health care lies. Dr. Hood is President and Co-Founder of the Institute for Systems Biology, an organization that is on the leading edge of looking at ways of combining large sets of personal health data, genomic indicators [...]

Non-Invasive Monitoring (and other things)

Let’s talk about non-invasive monitoring, body-worn sensors and what the future of medical devices might look like. A recent story in Medical Device and Diagnostic Industry (MDDI) reports that Fitbit is collaborating with several other companies to bring glucose monitoring capability to a smartwatch. That is hard to do. Many companies have been hoping to [...]

The Current Design Trend

This post was initially going to be about the increasing prevalence of home diagnostic devices. One recent device is from Athelas. The device can analyze blood from a finger-prick droplet. It is meant to be used at home to allow patients to monitor changes in disease progression or to catch at the earliest stage whether [...]

Tips for Intuitive Design

Keep it simple. The small details are extremely important. Using distinct contrast - in color, or value (light/dark) - is the best way to call attention to what’s most important. Understand that one size does not fit all. What seems intuitive to one might not seem intuitive to another, for various reasons. Understand that, no [...]

Behavioral Psychology and Medical Device Design

Psychology is a core aspect that influences all design. In this article from Medgadget, Matt Loper tells how a particular human psychological trait is the key to an app that encourages compliance with medical treatment regimens. Wellth is the app that Loper’s company has created. It encourages adherence not by giving something as a reward [...]

The Environment of Use

The product design process focuses heavily on the interaction between the user and the product: how the product is perceived aesthetically, what cues it provides that tell the user how to operate it, how it needs to be manipulated, what safety features it needs, how it might be used inappropriately. Another factor that should be [...]

Sensors and Smart Medical Devices

Tiny computing devices are being incorporated into the human experience in thousands of ways. Along with that, sensor technology is progressing rapidly. This trend will provide significant opportunity in the design of medical devices. With the wearable sensors that are available today, along with their associated apps, we are just scratching the surface of what [...]

Convergence of Diagnostics, Drugs and Devices

I am seeing a lot of stories in the medical press about new developments in diagnostic devices and point-of-care analytical systems. New microfluidic devices seem to be announced regularly. Imagine a future whereby you could deposit a small sample of your own blood or urine onto a microfluidic slide, insert it into a reader attached [...]

The Leading Edge of Medical Device Design

The PocketECG system from MEDICALgorithmics is a good example of where medical device design is headed. The PocketECG is essentially a Holter monitor combined with a physical activity tracker. What is significant is that, with data being collected on both heart rhythm and physical activity, it allows correlates to be established that can provide a [...]

From the Safety of Your Own Home

Will visits to the doctor’s office be a thing of the past? In late 2016, TytoCare received FDA clearance for its device that enables physical examinations to be done remotely. From their press release: “TytoCare’s modular exam tools and fully integrated telehealth platform enable a remote examination of the heart, lungs, heart rate, temperature, throat, [...]

Accuracy of Medical Wearables

A story at Medgadget presages an issue that is going to be of increasing concern for health and medical wearable devices. It appears that some approved devices now on the market are not as accurate in detecting physical events as initial testing had indicated. FDA approval was granted based on study test results, but now [...]


Wearable technology has advanced quickly in just the few years that it has come to be known as a category. The next wave in this progression is going to come from smart technology that uses the ear as its interface. Valencell  is a company that is pioneering advancement in biometric sensors. Their newsletter pointed me to [...]

Outer Space, Inner Space

One of the biggest problems with catheters is that they get clogged with biomaterial after a time, requiring intervention to replace the catheter. Researchers at Purdue University are looking at a way to use a magnetically-powered device to clear implanted drainage catheters. They have been able to place a device inside the lumen of a [...]

Graphene Hope Springs Eternal

One of the potential uses for graphene – the super-material that has yet to live up to its promises – is as a capacitor for storing electrical energy. I wrote back in 2013 about Ric Kaner’s lab at UCLA being able to produce sheets of graphene flakes. They found that the material could quickly gain [...]

Hacking the Brain

The past several years has seen a new emphasis on medical and scientific research delving into how our minds work. As we learn more about the brain and become adept at translating the electrical impulses that characterize thought patterns, we will see more and more interfaces that use thought to manipulate computers and machines. This [...]

Hydrogels in Medical Device Development

I have predicted that hydrogels are going to be a significant topic in medical device development in 2017, and recent news out of Duke University supports this. Duke researchers have been able to develop a “double-network” hydrogel that combines two different hydrogel materials and can be formed to shape using a 3D printer. Significantly, the material [...]

Starting a Medical Device Company

Designing, developing, and bringing a medical device to market is a complex undertaking. Both the design process and the means of production are regulated to ensure safety. The ramifications of the regulatory environment are often not well understood by start-up companies. How the company will eventually get paid for their technology is also a significant [...]

Home Diagnostic Devices

All kinds of medical devices are making their way from the hospital into the home. Diagnostic and monitoring devices are following that trend. A story from MedGadget reports on a portable tonometer, recently FDA approved, that patients can use in their homes or when they are traveling to monitor their intraocular pressure. I’m not sure [...]

What’s Up Wtih Graphene?

It’s been awhile since I’ve posted anything on graphene. There was a lot of buzz about it earlier in the decade, but the technological breakthroughs needed to make the material viable for use in commercial applications, including in medical devices, have been slow to materialize. Is there anything new to report? Not really … but [...]

Electronic Tattoo

Well, not really a tattoo, but a sensor patch made to look like one. Flexible electronics have been in development for a number of years now, and their practical use in the medical field is beginning to be seen. This video is about a patch that monitors the body’s sweat production so you can stay [...]

More on Hydrogels in Medical Device Design

My last post was about how hydrogels will be an important medical technology that will see significant developments this year. Further evidence of that from another report at Medgadget. Researchers at University of California, San Diego are using 3D printing methods to build millimeter-scale networks that mimic vascular structures. From the Medgadget article: “The new method, [...]

Hydrogels: The Most Important New Medical Technology

As a package for implantable medical devices, hydrogel material holds enormous promise. The topic is showing up with increasing regularity in the research and medical development press. In 2016, the developmental focus was on flexible electronics. That is still an important technology, and advances will continue to be made. But in 2017, the focus is [...]

Value-based Health Care

Value-based health care is replacing the fee for service model that the health care industry has been operating under for most of its history. Can medical device designers help in this transformation? Value-based care seeks to improve outcomes, increase patient satisfaction, and reduce the cost of care. Improving device design should have positive impact in [...]

Medical Device Design for Usability

Medical devices that are designed for good usability will minimize user errors. Negative outcomes are more likely to occur as a result of user error than of other device failure modes. In their paper, Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology JaiJie Zhang and colleagues discuss using heuristic analysis as [...]

Smartphone Medical Devices

I’ve written several times in the past about smartphones being employed as the base platform for medical devices and diagnostic instruments. A new milestone has been reached using that strategy by researchers who have created a device that can image DNA sequences and can reportedly perform mutation analysis on living tissue. The device is portable, [...]

Build Your Own Medical Wearable

You can now build your very own, customized medical wearable device. A company out of Scotland, Glasgow Neuro Ltd., is offering all of the individual components you need, along with a bio-amplifier that communicates to a smartphone or tablet via Bluetooth. Dr. Bernd Porr, has been instrumental in educating the public, via a series of [...]

Graphene Gyroid Geometry

Researchers have been trying to get graphene to behave as a 3D material for some time. Their work might have finally paid off, but not in the way expected. Graphene is one of the strongest materials that exists. It is also light weight and has electrical properties that could give it advantages in many functional [...]

Gamification Theory

A recent story about Reflexion Health’s Virtual Exercise Rehabilitation Assistant (VERA) points to the continuing progress that is being made in moving medical care out of the hospital and into the home. That trend has been underway for some time, and I think it will accelerate in the years ahead. With the continuing pressure on reducing [...]

Are Wearables at an Inflection Point?

Wearable devices that can tell you such things as how many steps you’ve taken in a day, or what your heart rate is have become fairly common. There are many devices out there, and consumers have embraced them. But most of these devices are limited in what they can do. For many people who try [...]

Thought-controlled Machines

I have written in the past about how we will be able to control machines using our thoughts alone. Advances in research into our ability to do so seem to be coming more frequently. The latest is news from MedGadget, out of the University of Minnesota. A team there has been able to employ non-invasive [...]

Sanitizing Robotic Surgical Instruments

A recent study performed by researchers in Japan has revealed that instruments used in robotic surgery are very difficult to decontaminate. The complexity of the instruments prevents cleaning and sterilization mechanisms from reaching all areas of the instrument. The instruments are not designed to allow disassembly to clean the interior of lumens. As a result, protein [...]

Robotics in Medicine

Robotics is moving into the medical sphere in a big way. Beyond surgery, robotic devices are going be developed to aid in many medical tasks and procedures. This story from MedGadget is about a robotic device developed at the Fraunhofer Institute that makes positioning for a needle biopsy much easier, accurate and efficient. I can [...]

FDA Guidelines for Medical Device Calibration

Guest post by Edward Simpson, RS Calibration, Inc. In biotech, biopharma and medical device industries, regular calibration is an important part of the FDA (U.S. Food and Drug Administration) approval process. Comparing measurements from a test device against a known reference or standard helps reduce measurement uncertainty and errors, bringing instruments within an accepted accuracy [...]

Selling Solutions along with Devices

Large med tech companies are offering education and training in support of their device products. We are at the beginning stages of a change whereby companies are considering how they can add value beyond simply offering a better device. Leading edge companies are looking at the entire ecosystem in which their products exist, and what [...]

Driverless Cars and Automated Medicine

Automation is coming to disrupt everyone’s lives. It’s predicted that soon, driverless vehicles will render the truck driving profession obsolete. Many other industries will be affected as well, including medicine. What might this new world look like, and how will we adapt to it? The impact on employment is obvious and will be massive. When [...]

Making Better Team Decisions

Medical device design is a collaborative process. That necessitates meetings with development team members to report on progress, discuss alternatives and solve problems. Group interactions can often spark great ideas via the interplay of the different perspectives and thinking that individual members bring to the group. Meetings can also be highly dysfunctional and a gigantic [...]

Innovative Suturing Device

Mellon Medical has developed a device that cuts suturing time in half. Their device is a great example of how re-thinking a problem can lead to revolutionary innovation. From the Mellon website: “Classical suturing is a complex process and takes a long time to learn. Focus is on getting control over the needle. Surgeons using [...]

Personalizing Healthcare

So Humana is using data they collect on their insureds to group them by “personas” as a means to tailor care in a more personalized manner. Personas are not new. They are used all the time in sales and marketing to help companies position their products in ways that will best appeal to people with [...]

Heart Defibrillation Using Light

Many recent technological advances in medicine and in other areas have been achieved by harnessing light in some manner. I have written on a number of occasions how I believe that this century’s innovations will be driven by finding new ways to control and apply light energy. The most recent news on this front comes [...]

Needle Free Medical Device

We all know that one person, the one who gets squeamish around needles and blood. They see the needle or the blood being drawn, and their face goes pale while their eyes get huge. Now, don’t get me wrong, I don’t like needles going inside me anymore than the next person. My arm veins actually [...]

Micro-invasive Surgery

Minimally invasive surgery is relatively common. Many procedures are done laparoscopically, with only a few small slits in the body required. On the horizon now is micro-invasive surgery – internal surgeries accomplished without having to disturb the dermis at all. One experimental approach being studied is using the body’s natural orifices through which to introduce [...]

Heart Disease and Hugs

Many people in the United States either suffer from heart failure or have a family member die from it. Did you know that, according to the Center for Disease Control, that one in every four deaths is due to heart disease and that it is also the leading cause of death in both men and [...]

Regenerative Bandages and Diabetic Ulcers

Did you know that the leading cause of lower body amputations is from infected ulcers caused by diabetes? Foot ulcers triggered by diabetes contribute to increased medical costs, hours of pain, and a lower quality of life for the patient. Now, biomedical engineers working at Northwestern University have developed a product to help address this [...]

Sleep Quality and Your Health

Everyone knows that getting the right amount of sleep is one of the most important aspects of a healthy lifestyle, but did you know that 35% of U.S. adults do NOT get their recommended 7 hours of sleep each night? Unfortunately, having a sleep deficit is a common problem for a lot of adults and [...]

Virtual Reality and Spinal Cord Injuries

Imagine being a paraplegic patient for years, then being able to learn to regain some control and feeling in your legs without undergoing invasive surgery. Well a group of eight people with the help of the Walk Again Project were recently able to achieve this! Since 2013, they have been conducting a study in Brazil [...]

Holograms in Medical Application

Imagine performing surgery on a patient using a headset that incorporates “mixed reality” holograms into the procedure. Well this may be something you are able to do in the near future! Microsoft has developed a device called the Hololens, and they are currently developing a holographic anatomy education program with Cleveland Clinic and Case Western [...]

Surgery With Magnets

One of the prospective technologies that I have been monitoring is that of non-invasive surgery using magnetics or injectable robots. A device that moves surgery in that direction has just received CE approval and De Novo FDA clearance. Levita Magnetics has developed a laparoscopic instrument that has a tip that can be detached from the [...]

Sea Change for Medical Device Makers

The fee-for-service healthcare model is being replaced by a value-based care model. This is a sea change, and therefore a significant opportunity for those who can envision ways of fulfilling the needs of the new market model. For medical device makers, opportunities lie in developing ways to extend device offerings to provide associated services and [...]

Blue Lights and Your Sleeping Habits

With our increasing attachment to our electronic gadgets, many people tend to spend time on their phones and computers late at night. Unfortunately, not everyone knows that the blue lights emitted from their electronic devices can negatively affect healthy melatonin production and the ability to sleep well at night. A company in Japan called JINS [...]

Electroceuticals and “Neural Dust”

Medical Design and Outsourcing reports that researchers at the University of California, Berkeley have developed a technology they are referring to as “neural dust”. The devices are tiny sensors, the size of a large grain of sand. When implanted in the body, ultrasound is used to vibrate a piezoelectric crystal in the device, generating electrical [...]

Where Medical Imaging is Heading

Medical imaging is heading to 3 dimensions, like everything else! A recent story at Medgadget highlights the accomplishments of EchoPixel and Hewlett-Packard in bringing a device to market that enables image data from CT and MRI scans to be viewed in 3 dimensional space. The system also allows physicians to manipulate the anatomy and view tissue [...]

Sensory Augmentation

This story in EETimes is about a trend that is well underway now, but which is going to grow even more rapidly in the next few years: the melding of medical technology with consumer products. The impact on economics and lifestyle will be sweeping. You could call “hearables” a subset of wearables, which already command [...]

Medical Device Reimbursement

The initial stages of developing a new medical device involves a lot of work around the technical aspects of the device and how it should be designed. Equally important is the question of whether it makes economic sense to pursue the idea. To answer that question, you need to know how public and private insurers [...]

The Fourth Industrial Revolution

I think everyone can feel that the world we live in is changing, and changing rapidly. Klaus Schwab, Founder and Executive Chairman of the World Economic Forum believes we are at the beginning of a fourth Industrial Revolution. According to the WEF article, the first revolution was about harnessing the steam engine to mechanize production. The [...]

Cut the Cords

Hospitals are filled with machines, instruments, and devices, all with cords that get tangled and cause frustration and pose safety hazards if not managed properly. The mass of cords, both in operating suites and in patient rooms, also creates an ugly mess. Designers do the best they can to address cord storage and management when [...]

The Shape of Things to Come

Medgadget reports that Healcerion, a South Korean company, has developed a portable ultrasound device that is no bigger than the transducer itself. It couples wirelessly to a tablet or smartphone. According to the report, the device isn’t meant to replace large ultrasound machines, but to allow ultrasound technology to be used in situations in which the [...]

Soft Robots

Vacuum-actuated muscle-inspired pneumatic structures. VAMPs. Developed at Harvard University and being adapted for commercial use by Soft Robotics, Inc., VAMP’s use vacuum instead of pressure to actuate a flexible body and cause it to contract. The action is likened to the way the biceps muscle works. This is a unique approach that carries a number of [...]

Disrupting the Healthcare System

A recent report that I noticed on the MedGadget website reveals how innovative companies are disrupting the healthcare system. The Trak male fertility testing system is a device that can be used at home to test sperm count. It has received FDA clearance. The product page claims that, after 500 hours of testing and clinical [...]

Surgery’s Future

Back in 2015, I wrote about where surgical technology is headed. New evidence to support that prediction comes from The story is about tiny, origami-like robots, folded in ice. When the ice capsule is ingested, the ice melts and the device unfolds, whereupon it can be propelled and manipulated by external magnetic force. This [...]

3D Printing Heart Stents

Guest post by Ronan Ye. The Heart of the Matter People come in all sizes and so do their heart arteries. Many doctors wish they could have custom fitted stents for their heart surgery patients. Currently, heart surgeons only have small, medium, and large heart stents to place in an artery. With rapid prototyping and manufacturing of custom [...]

More on 3D Printing Medical Devices

3D printing has been a hot topic for the past several years, with the cost of printers coming down dramatically, to the point where they are becoming a consumer item. Aside from its use for prototyping parts, 3D printing medical devices remains a novelty. Lately, however, there have been some developments with the technology that [...]

The Agile Manifesto

The Agile Manifesto is a story about software development, but its philosophy holds lessons that can apply to medical device design. The Agile Manifesto grew out of frustration with the “waterfall” model of development: 1) Establish requirements 2) Design 3) Implement 4) Verify 5) Maintain Reliance on this model resulted in a lot of attention [...]

Therapeutic Touch

Our sense of touch is a powerful emotional communicator. A gentle stroke, a punch, a pinch, a slap, a pat, a hand held on another’s shoulder – all of these register deeply within us. When we’re anxious or upset, simply being held is universally calming and reassuring. In medicine, the healing power of touch offers [...]

Powered by Light

My prediction that this century is going to be powered by light gets more credence with today’s big story in Wired magazine about Magic Leap. The webs are a-buzz with takes on the Wired article. If you don’t know, Magic Leap is a company that is working on delivering MR – “Mixed Reality”. Their technology [...]

3D Printing Medical Devices

There are beginning to be some meaningful advances in 3D printing that could make it the preferred manufacturing method for many medical devices. This report from the Fraunhofer Institute in Germany announces an additive manufacturing technique that allows multiple materials to be printed to form a single part. Fraunhofer has developed a way to create [...]

Smart Fabrics: Next Med Device Frontier

The Department of Defense is funding research into combining sensors, electronics and power generators into fibers, threads and yarns to produce advanced smart fabrics. According to the press release: “The institute will bring together nontraditional partners to integrate fibers and yarns with integrated circuits, LEDs, solar cells, and other capabilities to create textiles and fabrics [...]


Here is an interesting read about creativity from Medical Design & Outsourcing. The most important thing I got from the article is the idea of “Plusing” – a great concept, new to me. Plusing is an aspect of the creative collaboration method that Disney employs. It serves as a way to take individual egos out [...]

Flexible Electronics in Medical Devices

Flexible electronics are about to bring a revolution to medical device design. MC10 has been the pioneer in flexible electronics, and seems close to having a device on the market that utilizes their advantages in interfacing with the human body. Other institutions, such as EPFL (Ecole Polytechnique Federale de Lausanne) are also making strides in advancing the [...]

The Century of Light, Continued

Our ability to harness light energy to control mechanical systems and employ it in many other useful ways continues to grow. I have written how the 21st century will be the century of light. Optogenetics is one of the emerging fields that will have a significant impact in putting the power of light to work. [...]

Thought and Gesture

The way in which we interact with machines is changing. A lot of progress is being made in the area of gesture-based control and in thought-based control – controlling machines with our minds. Knobs and switches are going to give way to hand movement and brain waves. Eye movement and vocal commands are also being [...]

Predictive Medical Devices

More and more wearable devices are coming on the market intended to help people with their health and fitness goals. There will be medical devices that will adopt the system perspective of wearables and evolve to being tools that can predict upcoming health problems and enable people to head them off. Combined with family medical [...]

Design and Healthcare

I have written on several occasions in the past about how hospitals will be leaders in medical device design. More support for that hypothesis comes from Today’s Medical Developments and the University of Pennsylvania. Medical schools are realizing that design is the primary driver in the way people experience all aspects of the healthcare system, [...]

The Cost of Healthcare

The cost of healthcare was the big focus at the JP Morgan 2016 healthcare conference held in January in San Francisco. Attended by all of the major healthcare providers, it’s a window into what is going to shape the healthcare sector in 2016. According to reporting from Becker’s Hospital Review, these were the 10 topics [...]

Med Device Design and the Maker Movement

Med device design is typically done by companies with significant resources. Capital, design and engineering talent, and infrastructure to comply with regulatory requirements are typical of what it takes to move from idea to viable product in the medical space. The need for that foundation will not be changing any time soon. What is changing, [...]

A Disturbing Color Trend

I’ve noticed that a number of new medical products that have recently come out are employing a significant amount of black as the color for trim components and accents, and in some cases for the majority of the housing itself. From a patient’s perspective, this is not a good thing. Black is a good color [...]

The Future of Sensing Technology

Implantable biosensors are the future of sensing technology.  Not only will they be implantable, but they will be able to be placed in the body in a minimally invasive manner via injection. The Profusa company will be introducing an injectable oxygen sensor. One key to the technology is that it is built within a hydrogel scaffold. The [...]

Future Medical Devices

I’ve touted our current century as being the century of light . The latest evidence for this prediction comes from in a story about optoelectronic microprocessors. Using light to transmit data requires a lot less energy than using electricity. The reduced power requirements make optoelectronic chips an attractive field for applied research. Researchers at a [...]

Stretchable Medical Devices

Flexible electronics are the wave of the future. And combining flexible electronics with soft, pliant hydrogel material is going to transform medical product design. From MedGadget, we learn that researchers at MIT are developing hydrogel materials and incorporating sensors and drug delivery mechanisms into them. The key here is the flexible nature of the hydrogel, [...]

The Next Buzz

Patient Generated Health Data. Or, PGHD. We will be hearing more and more about this in the coming years. According to the Office of the National Coordinator for Health Information Technology (ONC),  “Patient-generated health data (PGHD) are health-related data created, recorded, or gathered by or from patients (or family members or other caregivers) to help address [...]

Software-Defined Batteries

I have written before about the fact that the lack of advancement in battery technology is a prime constraint in medical device design. A new approach developed by Microsoft researchers might enable some progress in this area. Via an article in MIT Technology Review: today’s batteries typically have a particular chemical design that defines its [...]


My November 3rd post was about how technology initially intended to help disabled persons regain physical function was being extended to provide able-bodied individuals with augmented strength and endurance. Prosthetics that enable the human body to surpass its inherent limitations are tools that we are going to see more and more of. Another example is [...]

Devices That Augment Human Capabilities

One of the trends we’ve seen coming is the use of prosthetics to augment human abilities. MedGadget has a report on one of the newer developments in this area – an unpowered exoskeleton designed to allow industrial workers to hold heavy tools for long periods of time. There have been a number of stories in [...]

Brain Research

Researchers at Sweden’s Lund University have been able to develop a flexible electrode that can be safely implanted in the brain and capture signals from single neurons. The electrode material is so flexible that it bends against the surface of water. The researchers were able to implant the electrode by encasing it in a rigid [...]

Ambient User Experience

This blog often speculates on what the future of medical device design might be, and what might influence it. An article from about technology trends for 2016 includes an interesting concept. Paraphrased from the article: “The device mesh1 creates the foundation for a new continuous and ambient user experience (emphasis mine). Immersive environments delivering [...]

Medical Device Design Inputs and Outputs

Medical device design inputs and outputs are your friend. After defining user needs, understanding how to develop and document design inputs and outputs is the critical quality task in medical device design and development. Properly identifying what the design inputs should be, and specifying them in such a way that they can be objectively verified [...]

Engineering Drawings, R.I.P.

I encourage you to check out this link to a blog post by Jennifer Heron at on using 3D models as manufacturing control instead of drawings. For at least the past two decades, product components have been designed in virtual 3-dimensional space, using various computer aided design tools. Where orthographic drawings were once needed to [...]

Optogenetics Advance

A story from MedGadget highlights the continuing advances that optogenetics is making. The optogenetics procedure involves using light to stimulate genetically altered neurons. Until now, research efforts have been hampered by the need to tether laboratory test animals to fiber optic cables in order to deliver the light stimulus. Stanford University researchers have now developed [...]

Wearable Medical Devices and the AARP

In recent posts, we have been exploring the relationship between new medical technologies and an aging population. Instrumental in this exploration has been the findings of the AARP’s Project Catalyst. Project Catalyst seeks to support innovation in medical device development by generating insight into the consumer behavior of older adults as it relates to health, [...]

Is energy-harvesting technology for wearables hard-boiled or hype?

As I wrote in May, the biggest constraint in any kind of medical device design today is battery technology, which has not kept pace with the progressive aspects of medical devices. But energy-harvesting technologies for use in wearable designs show promise, in spite of four key engineering challenges: 1) the power they generate; 2) how [...]

Brain-controlled Prosthetics

One of the most exciting developments in medicine and science is the possibility for humans to be able to control computers with their minds. In fact, it’s no longer just a possibility, it is actually being done. The NY Times recently had an article about an armless man who can control a pair of robotic, [...]

New Medical Devices Must Prove Their Value

Medical Marketing and Media (MM&M) has an interesting article regarding MannKind Corp’s Afrezza inhaled insulin. Initial roll-out of the therapy has been below expectations. One of the reasons for that, the article contends, is that the Afrezza therapy has not yet proven that it will provide increased value over other current therapies, pen injectors, for example. [...]

The Biggest Constraint on Medical Device Design

There are many new technologies in the development pipeline – and coming on-line – that will be incorporated into new medical devices in amazing ways. Unfortunately, advances in battery technology have not kept pace with advances in functional capabilities, miniaturization, and other areas. Often, the element that constrains design the most is the size of [...]

More Smartphone Devices

EyeNetra is introducing a series of products and a service that will allow you to determine your eyeglass prescription using a Smartphone. MIT Technology Review reports on the service, “Blink”, that will utilize add-on devices to smartphones – operated by a technician –  to determine your eyeglass prescription in your home or office (the actual prescription [...]

What Would Be A Good Day For You?

In this video, (hat tip to Dr. Lachlan Forrow, MD, shows how the simplest gestures can have the biggest impact in medical care. He brings to focus the most important factor in a patient’s wellbeing – showing genuine interest in them as a person. In caring for one of his patients – a 92 year-old [...]

Building a Better Inhaler

Metered dose inhalers (MDI’s) are one of the most commonly used drug delivery devices, with millions relying on them for relief of asthma symptoms and for treatment of other respiratory diseases. But the technology remains fraught with problems that medical device designers have been struggling to overcome. This excellent article from Today’s Medical Developments ( [...]

2-Dimensional Medical Devices, continued

This is definitely a trend. Several of my recent posts have been about how medical devices are moving from 3-dimensional objects to 2-dimensional ones. Stickers, electronic tattoos, etc. Yet another similar type of device is being developed at UC Berkeley to sense tissue damage due to pressure (pressure ulcers such as bed sores) before evidence [...]

Medical Devices in 2-Dimensions.

Several weeks ago, I wrote about how medical devices will be transitioning from 3-dimensional objects to 2-dimensional ones. The latest news in this area comes from UC San Diego, where researchers have developed enzyme-based inks that can be used to create low-cost, wearable sensors. The inks can be applied using a ball point pen. Also in [...]

The Future of Surgery

MedGadget reports on a surgical instrument developed by engineers at Vanderbilt University that is introduced into the body via a single incision and is controlled by a series of magnets. I believe this represents one of the first proofs of where surgical devices are headed: tiny robotic instruments that perform surgical procedures after being injected [...]

A Lump of Technology

Medical device designers are very passionate about what they do. We tend to get caught up in the object we are designing. How to make it beautiful, effortlessly usable, the greatest thing ever. As well we should. To most everyone else though, the thing we’ve so thoughtfully designed is just a lump of technology. It [...]

The Next Big Thing

I have been writing quite often recently about how medical research is focusing more and more on the brain. There is yet another story that highlights this trend. But there is another, more intriguing aspect to the story that portends a different impact. Via MedGadget, we learn that the company, NeuroVigil, has partnered with the American [...]

Imaging Single Neurons

  Each image is of the same exact neurons of a genetically defined group of cells. But some (left) fire while mice search for food; others (right) fire while the mice eat food. (credit: Garret Stuber, PhD) I believe that research into how the brain works is going to be a major focus [...]

Advanced Materials, the Brain and Optogenetics

“New fibers can deliver many simultaneous stimuli. Implanted into the brain or spinal column, they can transmit drugs, light, and electrical signals.” MIT scientists have developed a process by which they can produce flexible, multi-channeled polymer fibers that could simultaneously deliver drugs and optical and electrical signals. The polymer itself has characteristics that resemble human neural [...]

What Will Drive the 21st Century?

I have written on a number of occasions about Optogenetics and its promise for medicine. Here is another story, via Medgadget, that reports on advances in the field. In summary, scientists were able to use optogenetic techniques – which allows light to stimulate specific brain neurons – to induce REM sleep in mice. How might these advances [...]

The Patient Experience

I recently experienced today’s health care system first-hand from the patient’s perspective. One of the things that struck me was the amount of improvisation that took place in order to devise solutions for which a dedicated product wasn’t available. For example, showering with an IV line in place. In order to keep the IV dry, [...]

Designing the Experience in Medical Devices

“Experience Design” has been a methodological approach used in the consumer products industry for some time. Apple pioneered the practice, deliberately designing not only the product itself, but every aspect of the user’s interaction with it, from opening the package and removing the product, to setting it up, turning it on and using it for [...]

Medical Device Industry Growth

MedCity New reports on a study by A.T. Kearney that has some interesting findings for medical device design: The analysts say that the “emerging markets will save us” theory is false. Executives they interviewed have not figured out how to make the “Western” approach work in other parts of the world. The report suggests that companies [...]

EY Medical Technology Report: a Critique

Ernst & Young has been taking the pulse of the medical technology industry for several years, and has issued a report annually that discusses their findings. The 2014 report highlights the shift toward valuing better patient outcomes over other criteria. They also emphasize that one of the most important procurement metrics is going to be [...]

MedTech: Differentiate With Design

“Global Medtech industry needs to better differentiate products or face commoditization.” That is the conclusion of MedDevice Online in reference to Ernst & Young’s 2014 report on the industry. The ramifications are significant for medical device design. Indeed, in a commoditized market, design is one of the few things that can be used to differentiate a [...]

Medicine’s New Frontier

There is increasing activity involving research into how the brain works. The knowledge we gain as this research proceeds will have significant implications for medical device design and development. The latest news on this front is from Lawrence Livermore National Laboratory. They have received a grant from the National Institutes of Health to develop a neural [...]

The Essence of Design

Industrial design is not about products. It’s about visual information. The job of the designer is to provide the user with information that they understand, organized in a way that makes interacting with the product intuitive, executed in a manner that makes an emotional connection with the user. At its heart, design is about organizing [...]

Mind to Mind Communication

During the past several years, there has been a significant amount of research conducted on brain/computer interfaces. I have written about several programs that are seeking to enable computers and mechanical systems to be controlled by thought alone. The latest development comes from a report at Studies are being done that allow thoughts to [...]

Designing “Cool”

An interesting article in talks about social science research into what makes one thing seem “cool” and a similar thing not. Cool is a perception, not an inherent quality. It’s established in a very social process wherein a society’s trend setters adopt it (who determines who the trend setters are?), then it’s taken up by [...]

Doctors and Data

Personal fitness trackers are the rage right now. One of the hopes for these types of devices is that the data will be able to be used by physicians to keep their patients healthy. But will the data generated be of any use to the healthcare ecosystem? A recent article in Venturebeat suggests not: “… sources [...]

High Design vs Good Design

A recent article in the New York Times was about how Apple uses some Picasso lithographs to illustrate to their employees how simple design is created. Simple – meaning no frills – design is the basis of the Apple design aesthetic. The simplicity aesthetic originated with Dieter Rams’ work with Braun.  It’s an aesthetic and [...]

Another Advantage of 3D Printing

3D printing’s greatest advantage is in the flexibility it allows in part design – parts with undercuts and zero draft can be manufactured. A newly developed technique might give 3D printing another advantage: integrally combining multiple metal materials in the same part . The technique involves using a laser to melt metal powder in an additive [...]

Why 3D Printing Deserves its Hype

3-dimensional printing is one of the current big trends. You can now buy a 3D printer in some big-box stores and use it to print things in your home – toys, coffee cups, and whatever else you want to put a design together for. The consensus in the press is that 3D printing is going [...]

Big Medical Data

MIT Technology review recently reported how Express Scripts scoured data from doctor’soffices, pharmacies, and laboratories to detect patterns that might alert doctors to potential patient issues. They say they can predict twelve months in advance and with 98 percent accuracy whether a particular patient will be compliant with their medication regimen. If doctors know who [...]

Medical Device Future: the Hope and the Hype

I have been following new developments in the medical device space for a number of years. In that time, I have written about many technologies that have the potential to revolutionize medicine. Yet few of those technologies have been able to be commercially realized. Are these potential breakthroughs promising more than they can actually deliver? [...]

Open Source Hardware for Digital Health

Samsung recently (May 28, 2014) introduced their Simband platform: “A new health open reference design platform tailored to take advantage of the latest sensors, behavioral algorithms, battery technologies and displays. Devices based on the Simband platform will be able to gather vital diagnostic information - from your heart rate to your skin’s electrical conductivity, 24 [...]

3D Material that Behaves Like Graphene

Graphene is the miracle material that has proven difficult to commercialize for practical purposes. There are a number of approaches under way that hope to accomplish that. But now, Nature Materials (via reports about a new form of cadmium arsenide that has electrical properties similar to graphene but which might be easier to put to [...]

The Beginning of the Age of Bionics

One of the future trends I've written about has to do with sensors that will be implanted in the body. A recent article in  reports on how scientists have engineered a protein that changes shape when it attaches to glucose. Incorporated into an implantable device, the protein could be used to monitor blood glucose [...]

Using Light to Detect Glucose Levels

There is a lot of research underway into finding an effective and practical way to monitor blood glucose levels non-invasively. reports on a paper authored by researchers at Israel’s Bar-ilan University and published in the journal Biomedical Optics Express. The Bar-ilan researchers have developed a device that uses a laser to generate a wavefront of [...]

Biological/Computer Hybrid Thinking

Famed futurist, Ray Kurzweil, recently gave a TED talk in which he discussed his theory of how the brain works and how we will soon be able to augment our thinking by harnessing vast computing power in the Cloud. Rays timeline predicts that in the next ten years, search engines will be based on reading [...]

Glucose Monitoring Implant

I have written on previous occasions how sensing technologies will take the form of implanted devices (among others). The latest development on this topic comes from Sensionics . They are developing a small sensor designed to be implanted subcutaneously in the upper arm to detect blood glucose levels. From the Sensionics site: “Encased in a biocompatible [...]

Smartphone Medical Devices

Medical devices that couple to smartphones are becoming more and more commonplace. One of the latest is a design from MobileOCT that allows a smartphone to be used as a colposcope for detecting cervical cancer. The device is basically a case for a phone onto which a lens tube is clipped to provide the correct [...]

Medical Device Design: Find the Friction

In developing a successful medical device design, the most important step is identifying the true problem that needs to be solved. This is not nearly as obvious as it seems. Many devices and products have been designed, only to fail in the market not because they were designed poorly, but because they failed to address [...]

How About a Wearable Liver?

Nature Communications  has an article about new technology for filtering toxins that could lead to novel medical devices. Researchers Maling Gou & Xin Qu of Sichuan University, China explain in the paper they authored how they used nanoparticles to capture toxins in a 3D-printed hydrogel nanocomposite matrix. Nanoparticles can be injected for detoxification but the [...]

The Ultimate Wearable

A company called OMsignal  is coming out with a line of compression shirts that incorporate electrodes woven into the fabric. OMsignal claims the shirt will be able to track movement, respiration and heart activity. Another company, Hexoskin has a similar product already on the market. According to a blurb on their website, "They envision a future [...]

Medical Device Design: Context

One of the reasons products fail is because they’re designed as objects in isolation, without considering the context in which the object will be used. Design should be done in consideration of the whole system in which the object exists. The designer should also focus not on the object as much as what the object [...]

Medical Device Future: Point-of-Care Diagnostics

Testing and diagnosis is moving out of the lab and to the point-of-care. One recent example of this is the device that QuantuMDx is developing: a handheld molecular diagnostic and sequencing device to deliver rapid disease diagnosis at the point-of-care. Their goal is to enable routine real-time personalized medicine with a simple device that can deliver DNA [...]

Automatic Nutrition Tracking

The company, DataArt, is developing technology that will take an image of the food you eat and look up the calorie content. This approach is a logical next step in passive acquisition of caloric data, but it seems inelegant and cumbersome. With the advances in sensor technology that are taking place, it shouldn't be long until [...]

Skin Conductance and the Future of Wearable Sensors

Tiny increases in sweat gland production translate into large changes in skin conductance. This phenomenon is being used to study the medical implication of increased sweat production. Rosalind Picard, of MIT, has been using data from body-worn sensors to measure and correlate emotional states. Understanding emotion has significant possibilities for the treatment of autism, depression [...]

MannKind Receives FDA Panel Recommendation

MannKind Corporation has received recommendation from  the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) that their inhaled insulin product, AFREZZA, be granted marketing approval.  This is a huge step forward for MannKind and for the treatment of diabetes. Forma designed a range of inhalers for MannKind based on the AFREZZA technology, enabling [...]

Dematerializing Medical Devices

A few weeks ago I posted a blog about the future of medical product development  and how many medical devices would become “dematerialized” and take the form of implantables, injectables and electronic stickers. Now comes word that a device is being developed in the form of a bandage  that would incorporate strain gauges, a heating [...]

Wearable Sensors and Fitness Trackers

Recently, New York Times journalist, Albert Sun, published an article about his experience with fitness tracking devices. His original idea was to compare various trackers to see which ones were the most accurate. He realized that the compelling aspect of such trackers was not in the data they accumulated and how accurate that data was, but [...]

Medical Product Development and the Future

Patient accountability/partnership will become the norm. Preventative care and early diagnosis will be the focus. Biometric data tracking will be used to establish a “digital you” against which predictive models can be run to forecast health risk so preventative measures can be taken. Everything will be connected and interactive. Surgical intervention will become increasingly minimally invasive. Nano robots [...]

Design of Wearable Health Tracking Devices

Many companies are introducing wrist-worn bands that track your activity levels, calculate calories burned, monitor your heart rate, etc. One drawback to the wrist-worn form factor is that it limits the skin surface area that can be used for sensing. Flexible electronics are being developed that can conform to body contours. As this type of [...]


Optogenetics is one of the most interesting and promising of the new technologies in science and medicine. It involves modifying DNA with genes that make light-sensitive proteins. Modifying neurons in this way makes them react when energized by light. Most experimentation to date has focused on understanding how neural systems work and how they might [...]

The Opportunity in Health Data Trackers

An article in MedCityNews highlights an interesting point regarding wearable health sensors and the data they generate: how do users make sense of all the data they collect? This quote, from Catherine Calarco of Heartmath is telling: “People are still trying to figure out the design and presentation of the data. I’d like to see more user [...]

Medical Product Design and Patterns of Use

Here is an interesting example of use patterns impacting results: The Pecan Research Institute ran a study in which they analyzed electricity generation by solar panels that a) faced south and b) faced west. Most solar panels are mounted to face south because that orientation maximizes the number of hours of sunlight the panels can receive. [...]

Creativity in Med Design: Let Your Problem Incubate

When you exercise your muscles, you don’t see immediate gains in strength. It’s only after you’ve rested that the strength gains occur. Neuronal connections seem to act similarly. When you’re thinking hard about a problem, it’s rare that you’ll have a eureka moment. The insight usually comes only after you’ve let the problem ruminate in [...]

Medical Product Development and Randomness

Why do most people find it hard to be creative? One reason is that we’ve spent our lives learning how to be logical and analytical. To think creatively, you have to stop thinking logically. The emphasis on logic and analysis works well for helping us navigate most of the problems of our day-to-day world. But [...]

Non-Invasive Testing Using Sound

Non-invasive testing is a growing trend in medical device design and development. A new technique that uses sound to detect the presence of malaria has been developed by Drs. Dmitri Lapotko and Ekaterina Lukianova-Hleb and a team of  researchers at Rice University What the researchers at Rice have been able to do is to use a [...]

Iphone Diagnostics

Medical devices that use smart phones as part of their base technology are becoming more prevalent. And we are seeing more such devices being marketed to consumers, not just to the scientific community. This trend will be a boon for those in medical device design. One of the latest devices in development makes use of [...]

Creativity for Medical Product Design

This past week we conducted our workshop, “Break on Through to Creativity”, at MDM Chicago 2013. Workshop participants learned that, in medical product design, problem finding was as important as problem solving. They learned about the three barriers to creativity: perception, rules and logic. And they learned a number of techniques they can use to [...]

A Taste of Creativity

The workshop on creativity that we will be conducting at MD&M Chicago is coming up in less than two weeks. Here’s a preview: Are you a problem solver or a problem finder? Why does it make a difference in your creative approach? Why do most people find it hard to be creative? Three reasons. Think you’re [...]

Creativity in Medical Device Design

Ever wish you could be more creative in developing solutions for your medical device design problems? I and Forma’s CEO, David Chapin, will be conducting a workshop on creativity at this year’s MD&M conference in Chicago on September 10th and 11th. Here’s a synopsis: Break on Through to Creativity The goal of our Creativity Workshop is [...]

No More Gel for Electrodes?

There are a number of cardiac monitors on the market that can be used to monitor heart activity over a period of time. One of the drawbacks to current technology is the need for gel to keep electrodes in place and maintain electrical contact. Orbital Research, Inc.  has developed an electrode that doesn’t require gel. [...]

The Constantly Monitored Man

My last post was about medical devices in the form of adhesive patches. With sensors growing smaller and more ubiquitous in our lives, it stands to reason that we will soon be able to keep track of our vital physiological processes constantly and over a long period of time. Because we’ll have a vast data [...]

Patchwork Medical Devices

Flexible electronics and batteries point to a future in which many medical devices and body-worn monitors will come in the form of disposable adhesive patches. How will medical device design change in response? For medical device designers, the control and feedback components of such devices will be the important area to focus on. Wireless communication [...]

A Lab in Your Home

We have written on a number of occasions how it is becoming more common for medical devices to be used at home, instead of in the hospital or clinic. That trend appears to be occurring in the lab test area as well. Here is a story about a company developing a device that will allow [...]

Forma’s CEO Being Honored

David Chapin, CEO of Forma Medical Device Design, will be honored as Life Science Consultant of the Year by the Triangle Business Journal. David has been active in medical device product development for 25 years. In fact, 2013 marks Forma's 25th anniversary. As named inventor in over 40 patents, David has contributed great value to [...]

Video in Medical Device Product Development

Medical device product development will be utilizing advanced video technology and analysis algorithms to eliminate invasive methods of medical testing and vital sign monitoring. A clue to this future comes from the world of video gaming. The latest generation of Microsoft’s Kinect motion sensing system incorporates technology that allows it to measure your heartbeat via [...]

Intelligent Medical Devices

Here is a story from Medgadget about a device that helps people perform perfect chest compressions when performing CPR. We are seeing sensors being incorporated into many devices. Mostly they’re being used to monitor various processes and collect data for later analysis and feedback. The Physio-Control device suggests ways that sensors in devices can give [...]

Brain Work

The trend in medicine is away from the heart and toward the brain. We are seeing significantly increased interest and research into how the brain functions and how we might be able to repair neurons and nerve pathways to restore abilities lost to injury or aging. The Obama Administration’s proposal to map the brain is [...]

Get Motivated

You’re starting a medical device design project. Do you know what your goal is? It’s not what’s spelled out in the design spec. It’s not what the marketing group thinks your customers want. It’s not what’s been summarized from focus group research. Your goal is to satisfy motivations. Do you know what motivates the people [...]

Medical Device Design and Aesthetics

Jawbone has acquired Body Media. Both companies utilize industrial design to a significant extent to brand, differentiate and make their products compelling. With the combination of these two companies, we are sure to see even more high design in the wearable health device space. Predictions are for the wearable health device market to grow. Health care [...]

Medical Product Development and Users’ Hidden Needs

Medical product development efforts are often undertaken with the objective of introducing a new technology or implementing improvements to an existing one. Companies spend a lot of time and resources on the functionality, aesthetics and ergonomics of their solution, confident that their product will be a winner. And yet, most new products fail in the [...]

Medical Product Development and the Aging Population

It’s no secret that older individuals consume the bulk of health care resources. It’s also no secret that the US population is aging, as the baby boom enters its senior years. Medical product development is not addressing this phenomenon adequately. This article from Medcity News highlights that many companies are focusing on digital solutions. I fear [...]

The Hits Keep On Coming

I have written on a number of occasions about medical device technology being coupled with smart phones to provide their functionality. Medgadget  has a story about a device that turns an iphone into a fluorescent microscope or flow cytometer. Scientific technology piggybacking on smart phone functionality is one of the strongest trends I see in [...]

Medical Devices as Jewelry

The shrinking size of sensors and electronics, combined with new power technologies, will enable fitness tracking devices and other monitoring medical devices to be designed more along the lines of jewelry . Modularity and customizability will be the key to success here. One aesthetic will not appeal to everyone. Offering a system that allows base [...]

Preventative Care Fear

There is an interesting story at MedCity News. Seems that CVS is trying to get their employees to take an active role in their own health by encouraging them to live more healthy lifestyles. Several groups are calling the CVS program an invasion of privacy. I believe that we will be seeing more companies adopt [...]

Thinking About Electronic Tattoos

Last week I wrote about the medical device technology I think will advance in 2013. Two of those areas are flexible electronics and controlling devices with our thoughts. Well, how about combining those two ideas? Business Insider reports on just this scenario. Work is being done by MC10 and by NorthwesternUniversity and University of Illinois – [...]

Looking at 2013

In previous posts, we have taken a look at general trends in medical device design and medical technology. What about the near term future of 2013? In the coming year, I think we’ll see a lot of news regarding: Devices that attach to smart phones. Devices in development that incorporate flexible electronics. Progress in the [...]

Genomics is Beginning to Show Results

Two stories in the last two days illustrate that the genomics revolution in medicine is gathering speed and is about to deliver tangible benefits. The Tampa Tribune (via Medcity News) reports about a team of researchers that has found that persons with a certain genetic signature can prevent fatal heart arrhythmias by using a specific beta-blocking [...]

Design for Invisibility

Those of us involved in medical product design and development spend a lot of time thinking about product appearance and about how the user will interact with the product. As it relates to medical industrial design, these activities are at the heart of what we do. There are many methods, processes and techniques we employ [...]

Wiki Electronic Health Records

One of the newer ideas floating around is to make electronic health records work like wikipedia-style (semi)open-source documents. A person’s medical record could be accessed (with permission) by doctors and updated with new information. That way, there is one master record that is continually updated and current. This is a great idea on its surface, [...]

Stress, and Medical Product Design

Medical products are often used in stressful situations. Stress reduces cognitive function. In that environment, the importance of good design that helps products be intuitive to use should be apparent. Medical product design that achieves this can only be done if the designer understands human perception and cogniton As more medical products move from the [...]

Will Medical Device Design and Development be Led by Hospitals?

A number of hospital systems are establishing centers to help launch med-tech startups. The Cleveland Clinic is a pioneer in this area, with their Innovations Center. St Joseph Health has just launched the Innovation Institute, the heart of which is the Innovation Lab, which will incubate inventions that have come from the health system’s staff. [...]

Personal Diagnostic Devices

Smart phones are becoming ubiquitous. Devices that attach to smart phones are being developed by more and more companies. In the medical device field, a number of such products have been released in the past year. As this trend progresses, I believe we will see the advent of personal diagnostic devices. That is, lab-on-a-chip devices [...]

Too Much Information

When you are designing displays and interfaces on medical products, simplicity goes a long way in making the device easy to use. Every piece of visual information competes for our attention. It taks a lot of cognitive energy to decide what are the important things we need to pay attention to at the moment, when [...]

Genomics and Privacy

I am intrigued by a story in the New York Times (Jan 17, 2013), about someone who was able to use anonymous genetic data posted online to determine the identities of the those whose dna sequences were published. The implication is that disseminating genomic data will compromise individual privacy unless a strong security protocol is [...]

More Advances in Mind Control

Technology that allows computers and even mechanical devices to be controlled by thought is advancing at a remarkable pace. The latest development comes out of the University of Pittsburgh , where a woman with quadriplegia has been able to control a robotic hand via her thoughts, an implanted electrode grid, and an algorithm that translates [...]

Medical Devices as Part of Our Environment

The trend right now is toward wearable sensors and medical devices that can monitor our physiology, enabling us to reach health goals and warn of impending health problems. This is the next stop on the way toward technology that we don’t carry around with us at all, but that is part of our environment. There [...]

Medical Device Design and the Smart Phone

Pertinent to a very recent post , UCLA has announced an allergen testing device that attaches to an iphone. Medical devices that attach to smart phones are becoming more commonplace. What most of these devices provide in terms of power and convenience, they lack in elegance. For devices that couple with something as personal as [...]

Technology Divorced From Form

Misfit Wearables  will be coming out with a fitness tracking device in 2013 that is more or less a piece of jewelry with technology inside. The device tracks your movement (running, cycling, swimming, etc.) but the only feedback it provides is via a series of small led’s that tell you how far you’ve progressed in [...]

The Changing User Interface of Medical Devices

A transition is definitely taking place in the way we interact with electronics. We are moving form using keyboards, mice and graphical user interfaces to using voice, touch and gestural movement. How will this impact medical device design, and what do we as designers need to be aware of moving forward? Remarkably, touch capacitance works [...]

Medical Device Design for Specialist Groups

Medical device design for surgeons, nurses and others in the medical professions requires that the designer understand how these specialist populations use the devices that are unique to their specialties. The techniques that doctors and dentists use with specialized injection devices, for instance, is often not obvious to the lay person. It’s essential that direct [...]

Energy Parasites

Oregon State University reports that they have developed a technology that allows them to integrate multiple sensors onto a single microchip. The sensors replace what are currently large components in devices such as body-worn pedometers and fitness trackers. Rather than large, expensive, power-hungry devices, the OSU technology could accomplish the same sensing function in a postage [...]

First Gamification, Now Robotics

Intuitive Automata, Inc. will be introducing a robot – Autom –  that will act as a personal weight loss coach. Medgadget has the details. This is the latest development in harnessing technology for wellness. Previously, we’ve noted that companies were turning toward applications that use gaming and reward systems  to encourage attainment of health goals. It [...]

Cost Pressures

Medical product design is going to have to respond to increasing pressure on product cost. A medical product’s effectiveness/cost ratio is going to be a crucial benchmark as the healthcare delivery market is pressured to move from a fee-for-service model to one that rewards positive outcomes. Rather than working toward innovative advancements in treatment, companies [...]

Is it Time to Stop Listening to the Customer?

A revolt is fomenting within the design community. Researching and knowing the user has been a foundational priniciple of best-practice product design for some time. Now, however, I’m hearing with greater frequency the opinion that soliciting feedback from users doesn’t give you the answers you need. That users don’t really know what they want. That [...]

Human-Powered Medical Devices

In medical product development, one of the most significant challenges involves satisfying the power requirements of devices. This is particularly so with implantable devices, where replacing batteries requires a medical procedure. There are several intriguing technologies that are being researched to see if power can be provided by the human body’s own systems to drive [...]

Optical Glucose Monitoring Now a Reality

Medical device design is at the forefront of commercializing radical new technologies.  A little over two years ago, we posted about new technologies that were being developed to monitor blood glucose levels non-invasively . Now, C8 MediSensors,  has incorporated one of those technologies – Raman Spectroscopy – into a device that has received CE approval. [...]

The Picture on My Wall

Medical products are not used in isolation. I keep a picture of a crowded operating room on the wall of my office to remind me of the mess that is the environment in which most medical products are used:                         To maximize the usability [...]

Medical Devices as Consumer Products

Many companies are realizing that industrial design offers them a competitive advantage. This is just as true with medical products. Companies will realize competitive advantage if they employ design as part of their strategy. There is a clear trend toward limiting hospital stays. As a result, medical products of all kinds are being used more [...]

Cognitive Load in Medical Product Design

In medical product design, Cognitive Load is an important concept to be aware of. Visual complexity is an enemy because it overloads our ability to mentally process all the information we are taking in. Not only is it difficult to process a lot of information at once, having too much information to choose from inhibits [...]

Motivation, Part 2

The last post looked at how medical product design can be done in such a way as to motivate the user to prefer one product over another. Motivation also comes into play during the use of the product in that we are motivated by progress, mastery and control. Small signs of progress can have a [...]

Motivation and Desire

Another facet of cognition that medical product designers should understand has to do with motivations and desires. Though we learn to hide it well, at the most basic level we all harbor doubt, fear, insecurity and a sense of incompleteness. To counteract those feelings, we are drawn to objects that reflect our view of our [...]

Tell A Story

We process information best when it’s presented in story form. “Let me tell you a story…” is a powerful way to grab people’s attention. Because stories normally progress in a linear fashion, they imply that one event leads to another, that there is causation. Just as our visual system seeks to detect patterns that allow [...]

Don’t Assume

It is important that medical product designers not make assumptions about users. What might be obvious to you as the designer might not be obvious to those using what you’ve designed. People will always make mistakes. It’s impossible to design a perfectly fail-safe system. The approach to take is to anticipate as much as possible [...]

Mental Models in Medical Product Design

In medical product design, function is paramount. The device must work as intended, no questions asked. Proper function is often related to operation of the device in the proper manner. Designing a medical device in a way that clearly shows the user how to operate it must employ a knowledge of cognition as a basic [...]

Swiss Army Medical Devices

A number of medical products have come out in the past year that provide their functionality by coupling to smart phones. One device enables remote dermatology diagnosis. Another provides an add-on that can diagnose an ear infection. Still another turns an iphone into a microscope. We will undoubtedly see more such devices. For medical device [...]

Beyond Vision

In recent posts, we have been considering how medical product design can use knowledge gained from the field of cognitive psychology to suggest ways in which medical products and devices can be designed so they are more effective for users. We have written a lot about how the way in which we see influences our [...]

The Eye’s Mind, part 7

(Another in a series about how medical product design is informed by the science of cognition.) We want to see patterns and we like to create categories. If the designer doesn't provide informational categories, we will make our own. We want to create order. Patterns imply order, so that is what we look for. Medical [...]

The Eye’s Mind, part 6

It’s important in medical product design to understand that users will not always pay attention to visual cues the designer provides. Critical cues must be exagerated or given a treatment that draws attention in an obvious manner. Our eyes are drawn to contrast – both in color and in value (dark vs. light) – and [...]

The Eye’s Mind, part 5

The last several posts in this series have considered various aspects of the way we collect and interpret visual information and how that impacts medical product design. Another characteristic of our visual sense that is not often considered is the importance of peripheral vision. Whereas we use central vision to recognize specific objects, we use peripheral [...]

Medical Device Development and Nanotechnology

Medical device development using nanotechnology systems and techniques is just getting started. North Carolina State University will lead a National Science Foundation Nanosystems Engineering Research Center that will investigate and do basic research on self-powered health monitoring. The program is called ASSIST, for Advanced Self-Powered Systems of Integrated Sensors and Technologies. Funded by an NSF grant [...]

The Eye’s Mind, part 4

Last time, we talked about visual simplicity and how that relates to medical product design. In some respects, our desire for simplicity conflicts with our desire for control. We equate having choice with having control. Our need to control the environment is built into us, the hypothesis being that as we evolved as a species, [...]

Non-invasive Sensing Using Microelectronics

Medical product design is going to be impacted greatly by new technologies that are being developed to allow non-invasive testing and monitoring of things that now require finger sticks, blood draws, and other unpleasantries. We’ve written in the past about various technologies that use light,  and microneedle sensors, to accomplish this. Now, microelectronics are also [...]

The Eye’s Mind, part 3

(This is the fourth in a series about cognition and how it relates to medical product design). Effective medical product design is that which reduces complexity. Experiments have shown that we can hold only 3 or 4 pieces of information in working memory at one time. By designing to this limitation, you won’t overload the [...]

The Eye’s Mind, part 2

(This is the third in a series about cognition and how it relates to medical product design). The last post talked about how our minds can fill-in visual information that’s missing. Just as we can add missing information, we can also filter out information that we don’t need. Perception is selective. We naturally filter information [...]

The Eye’s Mind, part 1

(This is the second in a series about cognition and how it relates to medical product design.) When we interact with a surgical tool, medical device, lab instrument or any object, our first impression will most likely be visual. We’ll see the object and then begin to make sense of it and understand how to [...]

The Power of Genome Sequencing

Incorporating genomics technology will be increasingly important for medical product design as the cost of sequencing and analysis falls.  In the coming years, we will see amazing new devices that utilize some form of genomics technology as their foundation. This amazing story, that I picked up from MedCity News, confirms how genome sequencing is going improve [...]

Instant Diagnostics

A promising area of medical technology is emerging in which medical device design will be able to make a major contribution. We’re seeing a number of companies that are working on technologies that enable nearly instant diagnostic test results. Epocal is one, Abbott is another. Most of the focus seems to be on bedside administration, where treatment [...]

Algorithm Method

Medical device product development is advancing with the help of sophisticated computational algorithms that translate signals detected by non-invasive electrical and optical sensors into meaningful health data and images. We’ve written before about how computing power is being used to augment  and magnify the relatively crude information that current sensing technology can gather. Reflectance Medical [...]

Trends in Elder Care

Medical product design will be faced with many challenges as the U.S. population ages. There are trends that suggest that remote monitoring via sensor systems, care at home, and virtual coaching will all be areas in which there will be significant opportunity for innovative medical product design to have an impact. The trend toward care [...]

Medical Device Development and Data

  Medical device development will increasingly be driven by the growing amount of health data that is being generated. Even companies not traditionally in the device industry are realizing that they too will be impacted by the data deluge: For Craig Lipset, Head of Clinical Innovation for Pfizer, the future of pharmaceutical companies lies in [...]

The Data Driving Retail Healthcare

Continuing on the subject of health data – which was the big theme at the 2012 CONVERGE Summit for Healthcare Innovation – Brandon Rowberry, VP of  Innovation Development at UnitedHealth Group, made the point that the challenge for innovators in the medical device and healthcare fields will be in digesting the mountain of health data [...]

Engaging the Innovation Ecosystem

According to Dr. David B. Nash, Dean of the Jefferson School of Population Health, the healthcare economy is changing from one that encourages service volume to one that encourages better health outcomes. His mantra for the future is, “no outcome, no income”. This was the gist of Dr. Nash’s talk at the 2012 CONVERGE Summit [...]

Convergence Worth Investing In

What are the most promising avenues for medtech investors? That was the question discussed by a panel of entrepreneurs and venture investors at the 2012 CONVERGE Summit for Healthcare Innovation. It seems that medical product design could become dominated by software. Echoing the conference's overall theme of data, the big players are looking for digital [...]

Telemedicine at CONVERGE 2012

Telemedicine will be a fertile area for medical product design. The two biggest challenges in telemedicine right now are the difficulty in getting reimbursement for telehealth services and barriers created by inadequate cross-state licensing. From the Telemedicine breakout session at CONVERGE 2012: It’s difficult to get reimbursement for telemedicne practice because its benefits are as [...]

Medtech 2020

What will be driving healthcare innovation in the coming years? According to Kevin Schimelfenig, Dr. Ken Riff, Kem Hawkins and Richard Russo, panelists at the 2012 CONVERGE Summit for Healthcare Innovation, this: Innovation is needed in the process of care delivery. There are opportunities for big improvements in access, cost and quality. Markets outside the [...]

Avast, Ye Scurvy Dogs!

In the days when the sea was the best means of traveling long distances, the economic success of a country was heavily dependent on the geographical reach of their maritime trade and of their navy. Scurvy was one of the biggest killers aboard ship and limited the time a sailor could remain at sea. Finding [...]

CONVERGE: Healthcare Innovation, part 2

The future of medical device design lies in harnessing the massive amounts of health data that will be generated in the coming years. Other take-aways from the 2012 CONVERGE Summitfor Healthcare Innovation: Business models will need to change. Healthcare players are moving to expand their reach within the continuum of care. Improving patient outcomes: all [...]

CONVERGE: Healthcare Innovation, part 1

Data. That was the overarching theme of the CONVERGE Summit for Healthcare Innovation held in Philadelphia on July 10th. This quote from Dr. Ken Riff of Medtronic struck me in particular: “ data will be the healthcare currency of the future”. What implications does this have for medical device design? It will take time to [...]

CONVERGE: Healthcare Innovation

If you want to know where those at the forefront of the rapidly changing healthcare landscape see both disruption and opportunity, check back here. I am just returned from the CONVERGE Summit for Healthcare Innovation presented in Philadelphia by MedCity News. The agenda was jam-packed with excellent speakers and panel discussions about exciting developments and trends [...]

Sensors and Significance

The use of body-worn sensors to monitor physiology and provide usable feedback to individuals is still very new. Most of the devices we’ve seen so far track such things as heart rate, body temperature, respiration rate and calories burned and are used mostly as athletic training aids and weight-loss aids. Now, Orpyx is working to release [...]

Using Video for Monitoring and Sensing

I have written before about how computers will be used to enhance imaging data to give us a much clearer view of human physiology. The newest example of this comes from MIT, where researchers have been able to enhance video to reveal subtle movement and color changes that heretofore could not be visibly detected. See [...]

A Problem’s Soul

Medical device design, to be successful, must start with a crystal clear understanding of the true problem the device will be designed to solve. This quote, from Sonny Vu, in an article at MIT Technology Review,  superbly illustrates the point: “If you have diabetes, what’s your main problem? It’s that you don’t want to have [...]

Brain-Computer Interface

Controlling computers using the electrical impulses from your brain seems to be making advances. PSFK  reports on two companies, Emotive Systems  and NeuroSky,  that have developed headsets that allow users to control video games with their thoughts. The actions the devices allow are at present very limited, but indicates that the technology is definitely moving [...]

The Limits of Gene Sequencing

A recent article in the New York Times  points to a study of 53,666 sets of identical twins that looked for genetic predictors of disease. Turns out the study found little value in using genetic makeup to predict disease. An interesting finding, but not surprising, as the field is still in its infancy. As gene [...]

Does Everything Need to be a Game?

We’ve been hearing a lot about “gamifiication” to get people to engage in a variety of behavior-change exercises. Does turning something into a game provide sufficient motivation? For some people it probably does. For others, not so much. MIT’s Technology Review recently ran a story about a company that is developing devices and a virtual [...]

Wellness Pays Off

There was a story in my local paper recently about how a nearby town’s (Wake Forest, NC) wellness program has helped decrease the town’s insurance rates by 4.3%. Since the wellness program started in 2007, the town has gotten $75,000 in insurance credits, high-dollar claims have decreased and annual health care costs have leveled off. [...]

Genome Analysis News

MIT’s Technology Review recently ran a story  about a company that hopes to dramatically increase the speed of analyzing a sequenced genome. We’ve written in the past about how genome sequencing is getting faster and less expensive, but it still takes a year to do the analysis on the genome to derive any useful information [...]

Toward a Proactive Health System

Our health care system is expensive largely because it is reactive, attempting to correct problems that have already occurred. And those problems are often the result of long-term neglect on behalf of the patient. Our health care system would be much less expensive if its focus became predominantly proactive: aimed at keeping people healthy. This [...]

Hierarchy of Needs

Most of us are familiar with  Maslow’s hierarchy of needs that progresses from the most basic physiological needs up to the needs of self-actualization. A similar thing is going on with respect to products. That is, users have different needs relating to the products they use. The lowest level is function: the user just wants [...]


“Good design is as little design as possible” – Dieter Rams Dieter Rams is an icon of design. His work is based on simplicity and economy. Many of the designs he did for Braun in the 1960’s are as fresh today as they were then. Medical device designers can learn a lot from the way [...]

The Greatest Challenge

The TedMed 2012 conference was held last week. I was not able to attend, but the reports I’ve read indicate that preventative health was a big topic. In fact, of the 50 challenges proposed in TedMed’s Great Challenges program, the challenge voted number one was “inventing wellness programs that work”. From the challenges brochure: [...]

Taking Charge

Taking responsibility for your own well being is going to be almost mandatory in the future. No longer will we have the luxury of being passive consumers of healthcare managed and directed by others. Preventative healthcare will be extremely important. We will need to be active participants in our own care, and we will need [...]

It’s All About Preventative Care

PBS has documentary about several health systems in the US that are delivering quality health care to all citizens at the lowest cost. You can watch it here. There are a number of aspects that make these systems work in reducing health care costs. Chief among them is the fact that they focus on providing [...]

Data-enhanced Imaging

New information out of the University of Pittsburgh reinforces what we have been saying about enhanced imaging techniques: computer analysis will be used to augment imaging technologies to provide far greater clarity than we can achieve presently. The technique being developed at Pitt uses algorithms that analyze MRI scans to create brain images of neuron [...]

A Systems Approach to Health Care

Microsoft and GE recently announced partnership in their “Caradigm” venture, scheduled to launch in 2012. From the press release: “Caradigm will be aimed at driving a paradigm shift in the delivery of care by enabling health systems and professionals to use real-time, systemwide intelligence to improve healthcare quality and the patient experience. Upon formation, the [...]

The Family Tree of the World

That is what Andreas Sundquist of DNAnexus predicts we will be able to put together within ten years. That’s a fascinating prospect in itself, with far-reaching ramifications. But Sundquist’s real point is that DNA sequencing is poised to become routine. He thinks that by 2014, we will have sequenced a million human genomes, tens of millions [...]

What Health Care Will Look Like

In the coming years, we will be hearing a lot about coordination of care. Two recent items highlight this trend. First, is the concept of the patient-centered medical home (PCMH). Basically, the PMCH model calls for each patient to be under the care of a personal physician who is responsible for coordinating that patient’s care [...]

What’s Hot Now

More and more devices are showing up that track your vital signs, calories burned, etc. etc. As we’ve been predicting, personal informatics is gaining ground in the popular culture as a means of staying healthy. This is a subset of the move toward preventative care, which will become more and more important as the costs [...]

Fighting for Creativity

Most people will say that they value creativity. And they really believe that they do. But new research out of The University of Pennsylvania, UNC-Chapel Hill and Cornell shows that, in fact, we harbor a bias against creative solutions in favor of those we percieve as safer and more practical. The reason is because most [...]

Imaging Update

Last year I wrote about how new technologies combined with software data enhancement will revolutionize medical imaging. A new development in this area comes out of Imperial College London and the Agency for Science, Technology and Research (A*STAR). Scientists there have found a way to make electromagnetic terahertz waves (T-rays) much stronger while requiring less [...]

Genome Sequencing Update

In a post last year we noted that the cost of sequencing an individual’s genome was expected to drop to $100 and take less than ten minutes. We’re not there yet, but Life Technologies has announced that they will be introducing an instrument in 2012 that can sequence a genome for $1000 and do it [...]


A question was posted in one of the on-line groups I participate in: what purpose does beauty serve in the design of a product, and what value does it have? Behind the question seems to be the presumption that, in many peoples’ eyes, aesthetics is a secondary consideration to function. In medical product design that [...]

Go State!

Real-time monitoring of body chemistry using microneedle sensors might be coming soon, thanks to researchers at North Carolina State (ok, more accurately, the Joint Department of Biomedical Engineering, University of North Carolina and North Carolina State University), Sandia National Laboratories and University of California, San Diego. The press release explains that an array of hollow [...]

This is Just Cool

This one doesn’t have much to do with medical device design per se (other than enabling you to imagine how far and how quickly robotic surgery will be advancing), it’s just cool. Check out this video at Medgadget.

The Mind-Device Interface

There have been a number of recent stories in the medical press regarding developmental systems that enable direct control of both software and hardware devices using brain activity alone. I wrote about some of those systems here. The technology seems to be advancing quickly and has the promise of making real what was just recently [...]

The Data Gatherers

Medical device development is rapidly advancing in the area of wireless health monitoring. In a move targeted at medical device designers, Freescale has just introduced the Home Health Hub (HHH) reference platform. From their press release: “Freescale’s HHH reference platform provides comprehensive functionality and can be used as the foundation for connected medical product designs, [...]

Non-Invasive Sensing

Medical device design continues to benefit from advances in sensor technology. A sample of recent news: Everest Genomics recently announced that it will be releasing its CardioDefender diagnostic system: a wrist-worn ECG sensor device that communicates wirelessly with a smartphone. The system will allow real-time, long-term monitoring to detect, analyze and report heart arrhythmias. BAM Labs [...]

Too Exciting to Wait

I was going to wait until next week to post on the many recent developments that have come to the fore regarding non-invasive sensing of physiological functions and how that will impact medical device design. But this article by Frank Moss from yesterday’s NY Times is too timely not to give a shout-out too. It’s also [...]

MedTech 2011, Part 2

My second big take-away from Ibiliti’s 2011 Medtech conference was from remarks given by Dr. Ralph Snyderman, Cancellor Emeritus for Health Affairs, Duke University School of Medicine. Dr. Snyderman spoke about how, within ten years, the delivery of medical care will be vastly different than it is today. This has huge implications for medical device [...]

MedTech 2011, Part 1

If you’re involved in medical device design, the annual Medtech conference put on by Ibiliti is a great forum for learning about current issues in the field. Their 2011 conference was held on November 1st and 2nd in Chapel Hill, North Carolina. This year’s event was again very informative, with a good cross-section of speakers [...]

Attention on Wellness

The New York Times reports that Massachusets is working on a plan that would provide flat “global payments” to health provider networks that would act as incentives for them to keep their patients well. The hope is that the system will replace the current fee-for-service model that tends to increase medical costs because it reimburses [...]

More Developments in Wireless Monitoring

Development of technology for the wireless monitoring of vital signs and other physiological data continues to be a strong trend. The Universidad Carlos III de Madrid reports that scientists there have created an “intelligent” t-shirt that monitors temperature, heart rate, activity level and body position (standing, sitting, reclining). The shirt also embodies a localized GPS, [...]

Product Branding is About Trust

When people have confidence in your products, you will have loyal, repeat customers. That’s an easy sale. If you are not using design to brand your entire product line, you are missing the opportunity to leverage your customers’ trust. Because technical function is so important in medical device design, it’s understandable that the majority of [...]

Wireless Health Monitors

The Dutch Institute for Applied Science has developed a system for measuring body motion, heart rate and respiration using RADAR technology (watch the video posted at Quantified Self). This means that vital signs can be measured automatically via completely non-invasive means. The development team believes they can bring the system to market within a year. [...]

Personal Health Device Update

There is a new entrant in the personal health monitoring space. NewYu will be releasing a device in September that will help users track their exercise and calories burned. NewYu claims that it’s device can sense and distinguish between different types of movement, so it can tell if you are running, walking, using an eliptical [...]

Incredible Shrinking Device

Scientists at the University of Illinois have developed an ultrathin membrane inside of which they can embed electronic sensors. The membrane can conform and move along with the skin. Though the technology is not yet commercially viable, it points to where sensor and medical device design is headed: ever smaller. If electronics can be embedded [...]

Non-Invasive Detection Using Light

I wrote previously about a technology being developed at MIT that uses infra-red light to detect blood glucose. Now, Northeastern University is working on a technology that binds nanoparticles to a target chemical when injected into the skin. They can then use LED light and an iPhone to read the nanoparticles when they fluoresce. The [...]

Mind Control

A couple of exciting recent developments will have a big impact on medical device design in the future: The technology surrounding brain-computer interface seems to be advancing quickly. Toyota has a project in which they are using a bike helmet equipped with EEG sensors to identify the brain signals associated with a bycicle rider thinking [...]

Developments on the EMR Front

I wrote awhile back about the imperative of implementing Electronic Medical Records (EMR’s) on a widespread basis. The data such a system would provide would be invaluable in analyzing many factors that influence health and disease, and would reveal relationships that would be impossible to see otherwise. Initial efforts at such analysis and visualization are being [...]

The Medical Device Future

Medical imaging will have advanced immensely. We will be able to isolate and visualize physiological functioning in real time. Blood flow, gastrointestinal processes, even synaptic firing in the brain will all be able to be seen, analyzed and evaluated. Genetic analysis will allow people to focus preventative care on their individual aspects of greatest risk. [...]

The Value of Industrial Design in Medical Devices

One of the most important things that doctors, nurses, clinicians and consumers look for in medical devices is ease-of-use. In fact, in a study just released by IBM’s Institute for Business Value, 96% of respondents said that ease-of-use was the top factor in selecting one device over another. Ease-of-use will become even more important as [...]

The Big News

This week, Google announced that it was shutting down its Google Health service. Does this bode ill for the development and adoption of a universal Electronic Medical Records system? Not at all. It just means that Google didn’t get enough participation in the service to allow them to make money from ad revenue. There is [...]

P4 Future

P4 Medicine – Predictive, Preventative, Personalized, Participatory – is where healthcare is headed. In the near term, as the bulk of the population ages, there will still be a large portion of the industry devoted to treating disease. But more and more of medicine’s focus will be on neutralizing problems before they occur. Advances in [...]

A Second Imperative

I have been emphasizing how, in order to truly control health costs, it will be imperative to figure out how to get people to live healthy lifestyles in order to avoid disease and, in so doing, obviate the need for expensive interventionary care. In my reading about future trends in medicine, it’s become apparent that [...]

Personal Informatics Update

Last year I wrote several posts about the personal informatics trend – using technology to track our habits and various aspects of our physiology. At that time I noted how coupling devices with sensors to automatically collect data would help to bring personal informatics into the mainstream. Now we are seeing Ford Motor Company investigating [...]

Even More on Health Care Costs

Over at, Dr. Stephen Schimpff has some cogent thoughts about the root causes of rising healthcare costs in the United States. Doctor Schimpff reinforces my own view: that healthcare costs won’t be brought under control until we incentivize staying healthy. Read his post here:

Future Trends

Last week I wrote about the highlights from the FutureMed conference. Looking through the list, four overall trends emerge: Information technology for health. Personalized medicine. Control over biology. Targeted therapy. What do these trends mean for medical device design? First, medical devices that have any interaction with patients will need to be able to collect [...]

Highlights from FutureMed

                  The FutureMed conference was recently held outside of San Francisco. MedGadget has a more detailed synopsis, but here are the bullet points regarding the incredible technologies that will transform medicine in the not-to-distant future: Information technology will be playing an increasingly improtant role in medicine. Being [...]

Telemedicine Advances

InTouch Health is a company that has developed a number of devices and services that enable physicians to interact remotely with hospital patients for consultation and active monitoring. Their latest product is a the RP-Xpress, “a lightweight, rugged, portable device that brings the physician to the point of care”. This is the kind of technology [...]

More on Health Care Costs sights a study by Parks Associates that predicts that mobile health applications will soon be generating $5.5 billion in revenues by 2015. Of that amount, they say that 16% will be wellness/fitness related and 46% will be for chronic care monitoring and sevices. I hope the stats in their prediction are reversed. Only by [...]

Accidents Will Happen

Embrace them. Often times in creative endeavors, things go wrong. You play an unintended note. You draw an off-perspective line. But the accident gives you a new idea, or a different way of looking at the problem. Accidents can get you to places you never would have gotten to deliberately. They can often lead to [...]

The Imaging Revolution

Advancements in imaging technologies combined with the ability of computers to filter and enhance raw image data is creating a revolution in medical imaging. We are beginning to see techniques that provide realistic views of physical systems, organs and even cellular processes. Imagine being able to isolate a portion of a patient’s vascular system, see [...]

Creativity Suggestions

I was going back through some of my old papers and came across a piece from Newsweek written by Po Bronson and Ashley Merryman. Their article investigated what various researchers have found about creativity. It’s worth sharing the highlights: Brainstroming is not the best way for teams to come up with creative ideas. The same [...]

Containing Health Care Costs

Most of us agree that the continuing growth in the cost of health care must be brought under control. In our efforts to contain those costs, we will see the biggest savings if we can get people to live healthy lifestyles, preventing the need for interventionary care in the first place. Although it is receiving [...]

The Blank Page

To a writer, the most terrifying thing is a blank page. What to say? Where to begin? What if I can’t think of anything to say? What if my creativity is gone? Failure. The blank page can be paralyzing. One technique that writers use to get past their fear is to simply engage in the [...]

Innovation and Control

Corporations and managers love systems. They like things to be done the same way each time, in a step-by-step manner. Nothing stifles creativity quicker. There is no system for being creative. Hoping to develop medical device innovation by instituting a system is a fool’s errand. Leave the systems to the six-sigma folks. Your job is [...]

A Question of Balance

A body at rest stays at rest. A body in motion stays in motion. If only things were that simple. What we observe in the physical world is that everything is in a constant state of oscillation. You’re happy, you’re sad. You’re angry, you’re glad. The heart beats. Developing medical device innovation requires a similar movement [...]

Beware the Ego

Have you ever been in a meeting where creativity gets shut down because of something that happens in the group dynamic? Of course you have. Failing to effectively manage what happens in medical product development team group interactions is one of the biggest reasons why companies fail to innovate. Few companies are even aware of [...]

You Can’t Lead Innovation

Last week I told you that you can’t innovate because your leaders are afraid. But it’s not all their fault. There’s another reason you can’t innovate, and its source is at the top of the organization. That’s right, I’m talking to you, Mr. CEO. You want your managers to foster innovation, but you yourself are [...]

You Can’t Innovate

You can't innovate because your leaders are afraid. They’re afraid of doing things differently. They’re afraid of the consequences of failure. So they play it safe. They don’t risk much. They talk about innovation, but it’s only lip service. You know how to generate remarkable new ideas. You know how to create. But when your [...]

The Value Proposition

We attended the Medtech 2010 conference in Durham this week. The most important thing we took away was the opinion, expressed by several presenters, that the overall value a medical device delivers is becoming a more important consideration than simply its cost. In other words, medical devices that deliver better health outcomes in relation to [...]

Negative Innovation

Medical Devices Today recently cited an article from In-Vivo that talks about “negative innovation”. Basically, the idea is that advances in clinical value need to take a back seat to cost savings. In other words, not doing more with less, but doing the same with less. What this says to us is that cost reduction is [...]

Making the Right Decision

You’ve done a lot of research. You’ve developed some promising concepts. You’ve gathered the team together and now it’s time to evaluate and make some decisions. Amid the egos and agendas and politics, how do you make sure you’re choosing the ideas to move forward that will ultimately have the best chance of becoming a [...]

Data Enhancement

Last week we spoke about a new development in blood glucose sensing that uses infra-red light combined with a software algorithm that calibrates the signal. Using software to interpret, amplify and enhance instrument-acquired signals will become more common in imaging applications. Look to this kind of technology to have significant impact on future imaging devices [...]

The Future of Blood Glucose Sensing

Sticking your finger with a lancet will be a thing of the past. Non-invasive sensing will be a relatively near-term reality. One technology being developed at MIT is Raman spectroscopy, which uses infra-red light as a measurement collector. Read more about it here: Another technology being developed at the University of Washington utilizes nanoscale [...]

Preparing for the Future

What are the emerging trends in healthcare, and how can medical device designers prepare for them? Sustainability. There will be a drive to reduce waste in all areas of health care delivery. Reducing packaging and moving away from disposables and back to re-usables will become the mantra. Self-care. The high cost of conventional modes of [...]

Questioning Constraints

Far too often we’re presented with medical device design projects that arrive with constraints already firmly established. “We must use our existing manufacturing process”. “Our competitor has that feature, so we have to include it in our design”. “The filling vendors don’t like to do it that way”. If you’re really serious about medical device innovation, you [...]

True Innovation

Starts with courage. Courage to challenge the status quo. Courage to question constraints. Courage to defy the system. Courage to fight the me-too mentality. Courage to think big.

Sustainability and Medical Device Design

As the demand for sustainability grows louder, medical device design will need to find ways to significantly reduce environmental impact. This is especially so for single-use devices. Of the factors that affect sustainability, the type of material used and the amount of energy required at various stages of manufacturing, transporting and disposal are certainly major. [...]

Wellness and Self-Care

Medical device design is primarily focused on treating problems, not on preventing them. In the future, containing health care costs will increasingly rely on maintaining wellness rather than curing once a problem has arisen. Also increasingly, people will be involved in managing their own self-care. Rather than individual medical devices, they’ll need an integrated system [...]

Automatic Physiological Monitoring

We’ve written previously about personal informatics in health care, and have noted that sensing technology and automatic data capture need to get better before personal informatics can become mainstream. Here are some examples of the current state of sensing and automatic capture technology: Medtronic’s iPro2 system:         This device consists of a [...]

Personal Informatics: Automatic Data Capture

One of the biggest challenges in applying personal informatics in the medical arena lies in the sensing technology needed. Non-invasiveness and automatic data capture are the keys here. Currently there are a few methods that do capture some data this way: electroencephalography, electromyography, galvanic skin response, pulse oximetry, bioacoustic sensors. The Bodymedia Fit device [...]

Personal Informatics

We’ve noticed a trend that has many implications for medical device designers and that bears watching: the increasing prevalence of “personal informatics”. This is a fairly new phenomenon, and one that will grow substantially in coming years. What is it exactly, and where is it headed? Personal informatics has a number of different names: “health [...]

Health Care is Moving from Hospital to Home

One of the major trends in health care is that care once provided in the hospital or clinic is increasingly being provided at home by care givers or by the patients themselves. This trend gives rise to a number of issues that affect medical device design: Because users of medical devices in the home will [...]

How Will Personal Genomics Impact Medical Device Design?

Among the implications for medical device designers: Everyone will be able to have their genome sequenced. This will be a boon to laboratory instrument designers as the market for sequencers grows. Preventive medicine will become personalized. This could create a market for devices that do early screening for specific diseases. Specialization will occur with regard [...]

Cultural Differences

A few years ago, we conducted an extensive user research study in the U.S. and Europe surrounding a medical device design that addressed a less painful way of administering daily injections. In the States, Britain, Italy and France, every respondent was thrilled with the idea of less discomfort. The Germans, on the other hand, had [...]

Interpreting User Research

People are wary of things they aren’t familiar with. You need to keep this at top of mind when interpreting what users tell you. Most can’t articulate what they want in a design. They only know that this thing is new and it’s not like what they’ve used before. In medical device design, you won’t [...]

Designing for Patients

To provide quality health care, one of a physician’s greatest concerns is that their patients comply with the physician’s prescribed treatment regimen. An accurate diagnosis and proper treatment course will have limited benefits if the patient fails to comply with the regimen. In treatment regimens where a device is needed to deliver the prescribed drug, [...]

Where Innovation Goes to Die

Want to kill an idea? Put it before a committee. New ideas need a champion -- Someone who is vested in a successful outcome. Don’t expect casual players to push to the edges. It takes strength and decisiveness to drive a medical device design project beyond the ok and into the great. This is not [...]

Devices in Their Natural Environment

Hospital rooms, medical clinics and operating suites present unique medical device design challenges. For example, the operating suite is often filled with numerous monitors and electronic instruments. Each could be vying for attention at the same time. Designing medical devices to provide effective alarm feedback in such an environment is problematic due to the visual and auditory [...]

Manufacturing Constraints – The Good and the Bad

Injection molders in the medical device industry are experienced in achieving thin walls, tight tolerances and very small part features. In those respects, medical device design has fewer constraints than do other industries where walls are typically thicker and features larger for structural integrity. Generally, we do everything possible to eliminate undercuts and other problematic [...]

Smart Market

In the medical device industry, designers often deal with decision makers who are medical doctors or scientists trained in specialized fields. In order to communicate effectively with them, medical device designers need to quickly get up to speed with the scientific terms and jargon that medical and scientific people use in their daily interactions with [...]

Design as Differentiator

Many young medical device companies believe that their product will succeed in the market simply because their technology is stunning. When undertaking a medical device design project, why should such a company invest in industrial design? Because to not do so is bad strategy. Sure, revolutionary technology might be enough to get you established. But [...]

Testing Prototypes

In most industries, you can get away with testing early prototypes using parts fabricated from various rapid prototyping technologies. In medical device design, performance issues are often so critical and part features so small that early testing must be done using parts fabricated from the actual resin that will be used in the finished device. [...]

Can We All Just Get Along?

It’s always a good idea to use multidisciplinary teams in a product development project. In medical device design, the interaction between the design and engineering functions requires an even closer collaboration than usual. This is because design changes are often immediate and far-reaching. That is, an engineering change can have a significant impact on industrial [...]

Patent Envy

In all markets, products that have patentable features enjoy advantage over competitors. So why is intellectual property more important in the medical device design field? Mostly because product development costs are often so substantial that medical devices require a longer time period over which their development costs can be recovered. Patent protection provides this longer [...]

When To Think About Manufacturing and Assembly

In other markets, part features that aid efficient manufacturing/assembly normally don’t need to be considered until the detailed engineering phase of the design process. In medical device design, however, part holding and assembly features can have a big impact on device design. For example, the ability of a particular design to accommodate sterile assembly and [...]

The Issue of Sterility

The requirement for sterility is unique to the medical market. Some medical devices require that sterility be maintained throughout the assembly and packaging cycles. Other medical products need only be sterilized in batches after they are packaged. Reusable hospital and surgical instruments must be able to be sterilized repeatedly. Designing with sterility requirements in mind [...]

Good Design Wins Only Half the Battle

The other half is won by a convincing argument. We’ve all been through the experience of having a client insist on changes to a design that will make it, let’s say, less than optimal. I think most medical device designers don’t give enough thought to the “whys” of their designs. They know what works intuitively. [...]

Comply or Die

The Food and Drug Administration regulates most products that are used in the medical market in the U.S. Other industries are subject to strict rules as well, but I’m not aware of any that require as much control over the design process itself, as does the FDA. Thankfully the government doesn’t tell us how to [...]

Molecular-level Interactions – Small Can Be Big

In medical device design, what happens at the tiny scale of molecules can have a direct impact on what device designers do. In addition to biocompatibility issues, medical device designers need to be concerned with chemical reactions that could occur between say, drug molecules and device materials or between drug molecules and the outside environment. [...]


Some things just don’t get along with each other. That materials used in implantable medical devices must be compatible with the body is obvious. But there are unique material considerations in other areas of medical device design as well. The materials used in drug delivery devices, for example, must be compatible with the chemicals and [...]

Playing For All The Chips

If your laptop fails, little harm is done aside from some down time and the aggravation of having to have it replaced (ok, maybe more than a little aggravation!). If the interface on your digital camera is confusing, it’s annoying but you’ll figure out a way to get by. On the other hand, if your [...]

Medical Devices and the High Cost of Health Care

With health care reform so much in the news these days, cost containment is a big concern. Complying with the government’s regulations surrounding medical devices undoubtedly adds substantial cost to their development. How significant are those costs, though, in the overall scheme of caring for people’s health? Just about a year ago, former Congressional Budget [...]

The Specialized Nature of Medical Device Design

Industrial designers are trained in methods that allow them to design for many different industries. However, in the same way that medical specialists require additional training above their basic knowledge, medical device designers also need a specialized knowledge set. Some of the ways in which medical device design differs from design for other markets: The [...]