Health Science Entrepreneurship--what is it exactly?

I thought it would be useful to suggest a breakdown of startups in the Health Science-Healthcare-Medical-MedTech-Life Science sector. Sometimes all these companies are lumped together under one label, but there are so many variations, and each type has a different trajectory and timeline. To be sure, the healthcare sector itself is very different from other entrepreneurial ventures like software-only startups or self-driving cars or gaming augmented reality hardware/software startups. Software-only startups are the stereotypical Silicon Valley startup, “ramen profitable”, fail quickly, push-the-product-out-as-quickly-as-possible-despite-bugs etc. The majority of the Y Combinator companies are software only.

That’s not us.

Everything in healthcare is harder—even the software apps are harder because we have to get FDA clearance too. What that means is we need more time, more money, greater variety of employee skill sets, more expensive office/lab real estate, multiple stakeholders with decisionmaking power over purchasing, and fewer exit options.

So, in order of difficulty, here’s my list (feel free to comment or correct):

1. Software only apps: these could be keeping track of your moods or sugar intake, and anything in between. But if patients are making some medical decisions on the basis of the software app, you may need FDA clearance, though it might be easy to get, if it’s a low-risk, class I type of product. The software only apps are primarily used by patients themselves, without much, if any, physician involvement. The FDA is changing its approach to digital health and trying to simplify the regulatory environment. What does the FDA consider digital health products that it should review? The following are topics in the digital health field :

   • Wireless Medical Devices

   • Mobile medical apps

   • Health IT

   • Telemedicine 

   • Medical Device Data Systems 

   • Medical device Interoperability 

   • Software as a Medical Device (SaMD)

   • General Wellness 

   • Cybersecurity

2. Wearables with software: since I’m on my third fitbit in 3 years, I know it takes a lot of engineering to manufacture a quality wearable, so it’s already harder than software only. Wearables can take the familiar form of a fitness tracker but can also be innovative new hardware such as an insert that detects breast cancer, sensors that make your phone into an EKG, or an ingestible pill and sensor to measure medical effectiveness of medications. These devices are often sensors that are used in conjunction with the smart phone apps, and they usually require testing and studies of safety and efficacy. Generally these are also used by mainly by patients, though they may be uploaded to physicians or involve immediate diagnostic information sent to physicians.

3. Standalone medical devices that are used by medical personnel are the traditional products that come to mind when you think of developing a medical device. Often, their development takes years of prototyping and testing, and because they are usually used in a hospital or medical clinic environment, are subject to myriad and complex regulations and standards.

4. Most complex of all (and not covered in this blog because I don’t know much about it) Life Science Medical Startups—assays, tests, drugs, and therapies that require years of testing and clinical trials. Truly the marathon of health technology development. My hat is off to those of you that are in that space—but there won’t be much on this website that is useful except maybe the organizational blogs about corporate form, accounting etc.

So, for anyone interested in health science companies in categories 1-3, this blog may be helpful. My plan is to post about the nuts and bolts of starting a company and the many things we need to think about as we develop the product and the teams.