6 Medical Device Product Development Steps To Fast-Track Your Path To Market

When it comes to designing and developing a new medical device, there are a couple paths you can choose. The first goes like this: Gather some initial insights and then put your head down and get to work, trusting that you and your team will end up with a great device. 

I don’t recommend that strategy. As tempting as it may be to get to work immediately (who likes waiting around?), you’ll find enormous value in spending more time researching the needs of your users and employing prototypes to help you discover what features are actually important. This is the second path. And if you follow these six best practices, you’ll find that this path is actually faster and more reliable than the first.

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1. Set out to solve a real problem

To me, every medical device has a single, overarching purpose: to improve the quality of a patient’s life. The way the device does this is, of course, up to you. But improving the quality of life should be your north star. 

And the best way to ensure your device does that is to make sure it solves a real problem for a patient. If that’s not the case, market adoption of your device will be very limited, at best. You might think this is pretty obvious, but I can assure you that there are a lot of companies out there that don’t engage the patients and clinicians they’re hoping will use their device. Instead, they just… hope. 

If you want to build a device that will see market adoption and improve patient’s lives, you need to do some digging to evaluate existing products and the way the problem is currently being  addressed. You’ll also need to talk to prospective users of your device, whether those are clinicians or patients themselves. Only then will you have a good understanding of whether this device is going to solve a real problem for them. 

2. Define your intended use and indications for use

Once you’ve identified the specific problem your product will address, you need to define your medical device’s intended use and indications for use. Intended use is the general purpose, or function, of the device (what you claim the device does); indications for use describe the disease or condition that the device will diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population.

The intended use and indications for use are further expressions of the problem you set out to solve. These are also important because the way your medical device will be classified by regulatory bodies is a direct result of its intended use and indications for use. And your device’s risk classification will significantly affect the time and money it takes to get it to market, as well as your regulatory and reimbursement strategies.

3. Continually evolve your minimum viable product

Minimum viable product (MVP) was a term popularized lately by Eric Ries as part of the lean startup principles—and medical device startups are no exception to this principle. You too can embrace this concept of the MVP by using prototypes. Build your prototype, learn from it, iterate, and repeat. 

Think of your product development efforts as comprising several phases, and think of each phase in terms of its MVP. Your medical device evolves as you progress through product development. In the beginning, you had an idea or concept—maybe a cocktail napkin sketch or some screen shots. This was your first MVP.

The next stage gets a little more involved as you define intended use and involve end-users. Here, the MVP becomes more of a proof-of-concept prototype. Developing proof-of-concept MVPs, and putting these in the hands of end-users, will prove invaluable to your product development efforts.

This process continues as each MVP evolves and you continue to get closer to production. With each MVP, you should include end-users to provide feedback. This is key for one very simple reason: these end-users are going to be the champions of your product. Engaging them early and often will help ensure your product’s market success.

4. Integrate design controls and risk management

As you continue developing your MVPs, it’s critical that you document what you learn with each version. This is the essence of medical device design controls and risk management.

In the beginning, MVPs guide you toward what is important about your product for your end-users. What you capture and document at this stage will become your user needs. Once you have a proof-of-concept MVP, use this to help establish and define design inputs.

Design inputs are the foundation of your entire product development effort, setting the stage for all future development activities and connecting directly to any design verification (i.e., testing) you plan to do. Ultimately, using MVPs will help make your eventual go-to-market product stronger and more risk-averse.

5. Focus on the user

A more conventional and traditional approach to medical device product development goes like this:

• Come up with an idea
• Put your head down and work toward tackling the technical challenges
• Do a whole bunch of testing to prove your concept works
• Put a prototype device in the hands of end-users
• Cross your fingers
  

The conventional approach does involve end-users, but much too late in the product development process. The opinions and feedback of end-users are invaluable to the success of your product development effort. Do you want to get this feedback in the middle and latter stages of product development? Or would you prefer to receive this input and feedback from beginning to end?

6. Go slow to go fast

Medical device product development can go very fast — up until design verification and design validation. These stages are common points where development slows a bit. This is logical, because verification and validation (V&V) often involve a lot of formal testing activities.

Also, V&V is often a point in product development time when expenses start to increase dramatically. So, I’m guessing you want V&V to be smooth and somewhat predictable. The best way to achieve this is to slow down in earlier phases of product development. Specifically, spend more time defining design inputs. Design inputs are the key to your success, and MVPs are the key to defining design inputs.

Get an efficient, compliant product development solution with Greenlight Guru Quality

One reason that many companies end up going down the wrong path during design and development is that they aren’t using the proper tools. Instead of purpose-built software, they’re using paper or spreadsheets to manage their design controls—and it quickly becomes a nightmare they want to avoid. 

In fact, this problem is exactly why we built Greenlight Guru Quality in the first place. We knew that medical device companies needed a better way to document the design controls process, so we built our QMS software with visibility, connectivity, and compliance at its core. 

With Greenlight Guru Quality, you can create your design control objects, link complex configurations, and attach related documents quickly and efficiently. You’ll be able to create and update your traceability matrices and schedule design reviews in minutes. And you’ll always be audit ready when the time comes. 

Want to learn more about how Greenlight Guru can accelerate your product development while helping keep you compliant? Then get your free demo of Greenlight Guru today→