Designing the Right Medical Product Starts with Defining User Needs. Here’s How to Do it Right.

 In Design Strategy, Engineering, Medical Product Design

If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If yours is like the majority of medical devices, then the answer is yes. And that means it’s time to get up to speed on what exactly you’ll need to do to satisfy the FDA’s requirements.

Design Controls involve following a series of prescribed steps and rigorously documenting your product development process. The end goal is to prove to the FDA that your device is safe, effective, and successful in meeting your users’ needs. From producing a traceability matrix to documenting formal reviews, there’s a lot to consider when it comes to Design Controls. But, like any good product design, it all begins with — and ultimately depends upon — your team’s ability to accurately and thoroughly define your users’ needs.

It’s easy for product developers and designers to get excited about new technologies and design innovations — so excited, in fact, that they sometimes forget about the customers who will ultimately use their products. Remember, your users are the reason you’re designing a medical device in the first place. The whole point (other than growing your business, of course) is to design a product that helps users improve or maintain their health or others and, hopefully, makes their lives easier. So it’s imperative that you take the time necessary to truly understand what your users need and how exactly your product will satisfy those needs.

Defining user needs is the first step laid out in the Design Controls process. Once you’ve defined them, user needs should be the North Star that guides your entire product development process. Doing so not only helps you fulfill the requirements for Design Controls but also ensures that you design the right product for the market.

Here’s what you need to know to get user needs right.

Design Controls, Step One: Getting User Needs Right

What does it mean to start with user needs, practically speaking? These tips will point you in the right direction.

  • Don’t assume you already know your users’ needs. If you’re planning to develop a specific medical device, you probably already have some idea about who your end users will be and why they would want a product like yours. You’ve probably even done some market research to validate the need for your planned product in the marketplace. It’s a good exercise to start with your high-level guesses about user needs. But don’t make the mistake of stopping there. Even if you’ve served the same user group with past products, you need to let your users speak for themselves. Only by doing that can you gain a granular understanding of exactly what your users want and need from your product. Your original assumptions may prove spot-on — or you may discover something entirely new about how your product should be designed.

  • Don’t skimp on research. Once you accept that you can’t assume what your users want (even with educated guesses), it’s time to invest in research that will directly inform your official user needs documentation for Design Controls. This research may take the form of:

    • Competitive analyses of existing comparable products, including reviews and complaints of those products.

    • Interviews with users about your intended product.

    • Observational research in a lab setting.

    • Observational research in the field.

  • Frame your research around the right users. Your user research will only bear fruit if you identify and frame your studies around the right users. For example, let’s say your product will be used by nurses on a particular floor of the hospital to treat patients with a very particular health problem. Your user group isn’t just “nurses,” broadly speaking. It’s nurses who work in that very particular hospital setting and have experience treating patients with that particular issue. Only nurses with that level of experience can really guide your understanding of user needs for your product.

  • Observational research yields the richest results. While you should definitely talk with your users about your intended product, observational research will always yield the richest results. You need to watch your users interacting with your product, ideally in the context in which it will actually be used. (At the beginning of your development process, this will likely mean watching them use a competitor’s product rather than your own prototype). Only by watching users in this manner can you really see what frustrations they might have with your product. For example, your users may be so accustomed to taking a particular workaround with your product that they might not even mention it as an issue. Observational research also gives you insight into the environment in which your product will be used, including things like lighting, noise level, and any other equipment that might be used in tandem.

  • Document your finalized user needs for Design Controls. Design Controls mandate that you document your user needs in a way that clearly defines the full set of requirements around which your product will be designed and measured.

  • Translate your user needs into actionable design inputs. From the standpoint of product development, user needs aren’t truly actionable in and of themselves. They tell you what the product needs to accomplish for users and in what manner, but they don’t tell designers and engineers what to do to get there. So your next step in satisfying Design Controls is to translate your user needs into detailed specifications, or inputs, for your intended product. For example, let’s say your user needs specify that your product will be used on sleeping patients and should therefore be relatively quiet. That need would be translated into an actionable input by specifying that the device should run at no more than 30 decibels (the same decibel level as Rice Krispies in milk or 10 decibels lower than the volume typically needed to awaken a sleeping person). Those inputs can also then be verified (does it really run at 30 decibels or less?) and validated (is that level really quiet enough for sleeping patients?) as your product takes shape.

Once you’ve defined your user needs and translated them into design inputs, the real work of developing your product will begin. But the good news is that you’ve already laid the groundwork for success. From design outputs to verification and validation, every step moving forward can be tied back to your user needs in a concrete way.  Do that, and you’ll satisfy the requirements of Design Controls — and give your product the competitive edge it needs to own the market.


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