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, Jobs is now known to have done extensive market research with consumers before going to market.) You need to somehow discover what folks need, i.e. what will eventually sell. I humbly present 10 tips for defining medical products and devices.

medical products in use for measuring blood sugarHow do you know what to build?

Let’s talk specifically about new medical products, especially those which are personally used by clinicians – physicians, nurses, nurse practitioners and physician assistants – to treat patients. How does a supplier of such medical products determine what to develop and bring to market?

This question is easier to answer for other kinds of medical products such as drugs and diagnostic tests because those products are quite standardized in their presentation and have minimal interaction with clinicians after they are prescribed. They are substantially easier to define after a clinical need has been established — not a small matter but easier nonetheless.

The simplest answer to the question is: “Ask the clinicians what they need”. Well, it ain’t that easy! Here are some proven guidelines to follow in reaching a more satisfying answer to the question.

1Patients come first. Goes without saying, right? Perhaps, but you do need to establish with certainty that the well being of some patient class will be improved and/or their risks mitigated when the medical device is applied by a clinician. It’s also increasingly important to demonstrate that societal healthcare costs will be contained if not reduced.

 2. Just ask. A good place to start. Determine who are the likely users and ask them what they need. But who is the predominant user, and who is the predominant purchase influencer? They may be the same person or not. And you cannot simply ask “What do you need”. They may not know what they need, and they almost certainly do not know what can be delivered. But they do know precisely what job they have to do. Find that out, and make that job easier and/or quicker to accomplish.

3Just watch. What could be better than watching the targeted clinician perform that job? Nothing. Be there. Make yourself invisible, and learn. Watch especially for hang-ups, uncomfortable moments, complaints, time-consuming steps, error-prone activities, and such. After a procedure is done, ask what they found easy and difficult. Then go to work fixing the difficult steps. (Have you observed your physician specifying a diagnostic test to be run or a drug to be prescribed via their system-imposed EHR system? Now there’s a pain point to be addressed!)

 4. The clinician is a person. This reality is all too easy to forget. They don’t generally respond only to logical arguments and fancy new products. They know what is, and what is not, in their comfort zone. They also respond emotionally just like you. Your solution cannot be too unfamiliar or too complex. Perhaps it’s just the wrong color. Perhaps it will just take too long to learn. Or maybe they cannot imagine pitching your solution to the purchasing powers that be. Be prepared to react to the inevitable emotional responses. Maybe a focus group or clinician panel will do the trick.

5Gather from a diverse group. Since clinicians are people, they are all different. Be sure you are covering the territory: thought leaders, early adopters, late adopters, old hands, newcomers, and everyone in between. You must ultimately sell to all so it would be prudent to hear a variety of views.

 6. Push your developers into the field. Encourage – force if necessary – your scientists and engineers to visit healthcare workplaces and the clinicians who work there. Let them really get the feel of the place, the stress, the disorganization, the interruptions, the distractions and resulting errors and delays. Observing any prospective medical device’s environment of use will surely spur important questions and creativity.

7Better to ask highly focused questions. Ask when you have something to ask about. Not so much “What would you like to have?” as “What do you think of this product concept or that product benefit, and why?” Give clinicians something concrete to ponder, something they can imagine in their workplace. Later in the process expose them to a reasonably accurate concept model. Go all-in with product design professionals and so-called user experience experts.

 8. Consider asking patients. Self-treatment medical products are becoming ever more common. In those cases it’s imperative to get patient opinions and design guidance as well. The more intimate and intrusive the device, the more critical are patient inputs.

9Guard your secrets. You may not much care if your competitors learn that you’re conducting market research in an obvious, familiar space. But if you’re up to something very different, know that your competitors will inevitably find out. In that case consider third-party support for your research.

10. Share the wealth smartly. Don’t overlook the critical importance of sharing the expertise that you develop with your in-house team – not just the raw data, but some carefully crafted conclusions, the analysis behind those conclusions, and the resulting influences on your internal development plans and budgets. Whether your research is conducted by in-house staff or a consulting partner, its results must be widely shared, uniformly understood, and acted upon effectively throughout your organization.

At Forma Medical Device Design, we develop innovative solutions that function the way they need to, under the constraints of the setting they’re used in, efficiently for the user. If you’d like to learn more, please contact us.