Risk Intelligence

Ten patterns worth a closer look in medical device diligence

A free guide for investors evaluating a device company and founders preparing for diligence: what each pattern looks like, the signals that suggest it may be present, and the questions worth asking.

Evaluating or building a medical device company right now?

Three of the ten patterns

None of these decides how a company will turn out. Each one is a reason to look more closely and to ask for evidence, whether you're running diligence or planning a company.

1

Reimbursement strategy developed after regulatory submission

Teams can optimize for clearance speed without confirming that hospitals can get paid for using the device. If the reimbursement gap surfaces only after FDA action, the commercial timeline compresses and runway goes to a go-to-market plan that doesn't work.

2

Market size projections based on diagnosis prevalence

A pitch deck sizes the market from the number of patients diagnosed each year. The addressable group is smaller: not every diagnosed patient is a candidate for a procedure, not every candidate is treated with a device, and not every device-treated patient receives this one. Each filter can shrink the market substantially.

3

Competitive analysis that ignores off-label use

Formal competitive landscapes map device vs. device. But physicians often solve the same problem with an off-label application of something they already have. If your competitive analysis only covers direct competitors, you may be missing the real barrier to adoption.

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+ 7 more patterns in the full guide

Get the full guide

All 10 patterns, the signals that suggest each one may be present, and the questions to ask, whether you're running diligence or preparing for it.

14-page PDF. About 10 minutes to read.

Each pattern includes the signals to watch for and the specific questions to ask before you commit. Written by Arvind Ravinutala, MD, and Aswini Ravinutala, BME.

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