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The 3 R’s of Medical Device Development: Research, Regulation, Reimbursement

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In our last blog, we laid out 5 pre-funding essentials for early start-ups. Today we want to delve further into three critical topics. Each has special significance not just at the pre-funding stage, but throughout the development cycle.

1) Research – Good research is the foundation of your medical device, but you don’t just need top-notch technical research. You need to thoroughly understand the market your product is designed to reach. Even if your initial market research looks promising, be sure you dig deeper to look at all facets of your intended market. For example, does your market already know they need your device? Or are you going to have to educate them about its benefits? If your ultimate goal is acquisition, how will you quickly infiltrate existing market channels to show your device’s potential? Effectively demonstrating potential for market dominance will make your product funding proposal stand out.

2) Regulation – Plain and simple, your device must gain regulatory approval in the countries in which you wish to market. The first step begins with initial inquiries and proper classification. As you may already know, in the U.S., Class I, II and III devices have increasingly stringent regulatory controls. Your device classification depends not just on its intended use, but the indications for its use. Classification determination begins with the analysis of both intended and indicated usage, which are also critical factors in device development. From there, exemptions and equivalencies can further alter the regulatory approval path. Remember, no one will fund, continue to fund, or acquire a device that has regulatory hang-ups. A pro-active regulatory approval strategy is the key to keeping your development on track.

3) Reimbursement – You’ve done your market research and you know where your buyers are and how to find them. You’ve been following a regulatory approval strategy that gives every indication of ultimate success. Now comes the Achilles heel of the new medical device: Reimbursement. You may have the greatest medical device in the world, but if insurance companies will not sign off on subsidizing its use, you will never get it off the ground. Will your device fall into a standard class, or will it require a new reimbursement code? If the latter, how will you make a strong clinical and financial case for reimbursement? This is why we always recommend an initial reimbursement analysis for any device, so you have an early understanding of where your device stands. Reimbursement has a direct effect on the valuation of your company, and your prospects for funding or acquisition.

REV.1 Engineering’s program management protocol takes all aspects of your new and growing business into account. Our long-standing relationships with referral partners allow us to fill in the gaps for the roles you need to bring your medical device to market – reimbursement analysts, regulatory approval consultants, and market researchers are just a few of the specialists we can add to the team.If you’re a start-up in need of angel investment to move forward, we’re ready to dive in and prepare a gap analysis to highlight what you need to secure funding for your medical device development. We can get your device moving … 2x Faster than if you tried to build an in-house team. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at, and let’s get your start-up started!

Eric & Phil