Startups are the lifeblood of the medical device industry. Large medtech companies depend on startups to eliminate some of the risk of new technologies. It would not be good for a large corporation to put a whole lot of time and effort into a new technology that doesn’t come to market. It’s a wide, long road, and it’s an expensive road, and startups want to travel it once. They want their final product to be perfect in every way and to have every feature that any person could want, and that is challenging. It requires avoiding some common mistakes.
#1 Feature Creep
The biggest mistake startups make is trying to cram too much into that first device. When you start adding bells and whistles, that increases your timeline, it increases your budget, and it opens you up to more scrutiny by the FDA. We advise them to take a little time and think about the core things that are needed. Those core features are going to drive your minimum viable product (MVP). Get those done, get those right. Keeping the feature list limited keeps your budget needs limited. Requirement creep will be the death of your product. On the other hand, make sure you know what is really needed, and put that in.
#2 Not Doing a Feasibility Study
Another big problem is that if you’re bringing to market something that hasn’t been done before, you may run into unanticipated problems. The more unprecedented your project is, the longer it’s going to take, and the more it’s going to cost. As Murphy’s Law says, “If anything can go wrong, it will.” You have to plan for that. It’s important to understand what is risky and not risky. If the technology is unproven, do a feasibility study, or at least investigate enough to be sure your risk is low.
#3 Under Estimating the Amount of Work for FDA Requirements
The FDA cares that the device is safe. A non-medical commercial device can be just good enough. A medical device has to be safe and effective, and that takes time and money. The FDA requires a lot of documentation to prove it. A good rule of thumb is to plan on a medical device costing about three times as much as a consumer product to develop and prepare to sell.
#4 Ad Hoc Processes
Startups often use ad hoc processes to explore the application needs and develop the product, but to get FDA approval a proven design control process needs to be used, Product specs must clearly and unambiguously articulate the product’s features, functionality, and behavior. Careful writing of the product requirements can aid in a more rapid approval process, and they are essential for the verification process. Here is a whitepaper on Developing Product Requirements for Medical Devices.
# 5 Not Getting the Right Expertise
Find people who know how to build the kind of device you want to build, people who can help you not only develop the product, but get it through FDA. We work in partnership with startups to ensure that the right product is being developed, that it will rapidly get FDA approval, and that it can be manufactured easily to get the product into the marketplace quickly and at minimum cost.