Early feedback during medical device development saves money, avoids risk, and accelerates time to market.
Back in 2007, the car maker Volvo included a heartbeat sensor in their S80 model. So if someone was in your car, your key fob would indicate a heartbeat. The demand for this feature, not to mention it’s use, was quite low. Volvo shelved the idea. See the video here.
When developing medical devices, companies fall into similar traps. Just because something appears to be ingenious, doesn’t make it viable. Let’s find out how to avoid medical device development pitfalls in the earliest stages.
Your First Medical Device Prototype
A list – that’s it. And maybe a sketch. Medical devices aren’t pet rocks, so if the idea alone isn’t viable, you won’t get far. The first step is to outline your product definition and features. Items to include are:
- Intended use – What does your device do?
- Indications for use – What condition will your device diagnose, treat, or prevent? Who is your target demographic sector?
- Features and functions list with brief descriptions
And that’s it. That’s your first prototype. Before you spend a single second in the development lab, real end users and stakeholders should vet this summary. The early validation of the items listed is critical. Otherwise you might head down an expensive path that results in a key fob nobody wants or uses.
Intended Use And Indications For Use
Pay special attention to these categories. They carry a large impact on your development process. Furthermore, regulatory bodies will classify your device based on these definitions which also determine approval process times. Finally, indication for use will determine how to collect payment for your device when it hits the market. Considering these factors early save you time and help define your market position.
Documentation of Your Prototype
From this early stage, be sure you meticulously document everything. This serves two purposes. One, you build a library of info upon which to guide further development. Second, you construct a solid platform upon which you can please regulatory requirements.
When you provide this list for evaluation, questions and suggestions will arise. This forces you to come up with answers helping ensure eventual market and regulatory success.
Ongoing Iterations of Your Design
After this first evaluation round, you might be tempted to do some benchwork, but wait. Review all the data gathered and come up with a second, refined list. Then go back with your new prototype list and get feedback. From there you can move forward with actual lab testing and development.
Set Milestones for Developing Your Prototype
Along the development process, be sure to set logical milestones where you’ll ask for more third party input. Avoid the temptation of going overboard seeking feedback. But for each major advance, consider returning to gather end user and stakeholder opinions.
Alone, the developer might not recognize a new need or an unnecessary function. An objective view often provides valuable insight that escapes the development lab.
Avoid risk and shorten time to market. Get advice on medical device development from industry experts. Contact MedtoMarket today.