So you’ve got an idea for a new medical device. What’s the first thing you want to do?

If get money to make prototypes is your response, perhaps you might want to think again.

Sure, SBIRs (Small Business Innovation Research grants from the US government) are out there specifically to support such work. The urge to get hands on and make something is tough to resist, especially if you’re an engineer by training. But if your goal is to build a business and solve a problem, I recommend holding off on the proof of concepts, bench-top testing, and rapid prototypes.

I know, if you have a working prototype you can get customer feedback and use it to get funding for your company. But those funders, whether angel investors or venture capitalists, will ask you these types of questions before giving you one red cent:

• What’s your “killer app”? (I know, you’d think they wouldn’t say that in healthcare!). By killer app they mean what is the critical problem you solve with your idea? In today’s healthcare environment that boils down to can you make care faster, better or cheaper…and ideally all of the above.
• What is the evidence (data) that validates your idea that you can improve patient outcomes, improve safety/quality of care, or reduce the cost of care? You may be thinking how am I going to get evidence without a working device, but at the early stages you need a rationale and then a plan to validate your rationale.
• Who are the 5 KOL (key opinion leader) clinicians that will attest to the fact that your idea (a) will do what you claim (assuming the technology works out) and (b) will buy it when it’s approved for sale.
• What is your reimbursement strategy? It’s hard to get hospitals/physicians to purchase and clinicians to adopt new technology unless there’s an economic incentive to do so. If “new code” comes out of your mouth, you’re in trouble because it’s unpredictable and takes a long time to get a new code. So, if you can get approval for reimbursement using an existing code, all the better.
• What is your regulatory pathway? To investors, the FDA is an unpredictable, time-sucking hurdle. The fact that current approval processes are under review and changing creates uncertainty, the enemy of VCs and Angels. Ideally you have a number of recent predicates that will enable a 510k submission. And if you were thinking of going the CE route and enter the U.S. market after a European entry, be prepared to reduce the early sales in your revenue model as the healthcare markets are smaller and adopt more slowly than the U.S. market.

Bottom line: Investors will be thinking up front how they are going to get their money out of your company up front. The first step in building that case is getting really solid answers to the above questions. Following that you can begin to think about your team, technology and testing plans…and your company’s exit strategy. But before you put money and time into prototypes, think about building your healthcare business case. If you do, you may find a way to bootstrap your business as good ideas attract money and people.