Physicians are increasingly interested in medical innovation for several reasons:

  • We have an innate intellectual curiosity. 
  • We desire to offer the best care for our patients.
  • Many of us have experienced burnout from COVID and administrative frustrations. 
  • Many of us are looking for opportunities for additional income.
  • Some of us are interested in career transition.

Whether your entrepreneurial background includes an InnovatorMD Conference, a Society of Physician Entrepreneurs event, a StartUp Health Festival, or an AngelMD Pitch Club, I wrote this article to describe a healthcare framework physicians can use to evaluate healthcare companies and to encourage investment and involvement in the innovation process.

Use the 7 P’s below to identify a company’s strengths and areas of improvement, describe opportunities for improvement, and influence future company goals. This framework informs investment decisions. It can also be paired with your unique professional background to offer relevant insights as a company advisor or chief medical officer (CMO).

Product

The first step is to evaluate the proposed solution and how well it addresses a medical practice pain point. The company may be in the idea phase, may have a minimum viable product (MVP), or have a functioning prototype.

Ask:

  • Is their solution better and cheaper than the available alternatives?
  • How big of a pain point are they addressing?
  • How big is their potential market?
  • Was the solution built by experts in their space?

Process for product clearance

While not every health innovation requires FDA clearance, understanding how a product you’re evaluating is regulated is important for assuring patient safety and mitigating potential risk. Understanding the approval process also helps you budget for future regulatory needs.

Ask:

  • Does the product have 510(k) clearance for a medical device, early-stage FDA clinical trials for a pharmaceutical, or Software as Medical Device (SaMD) approval for an artificial intelligence algorithm?
  • In addition to US clearance, have the company applied for a CE mark to sell their product in Europe?
  • Has the company looked at product approval for other international markets?