Opinion, Berkeley Blogs

Lessons Learned in Medical Devices

By Steve Blank

This post is part of our series on the National Science Foundation I-Corps Lean LaunchPad class in Life Science and Health Care at UCSF. Doctors, researchers and Principal Investigators in this class got out of the lab and hospital talked to 2,355 customers, tested 947 hypotheses and invalidated 423 of them.  The class had 1,145 engagements with instructors and mentors. (We kept track of all this data by instrumenting the teams with LaunchPad Central software.)

We are redefining how translational medicine is practiced. It’s Lean, it’s fast, it works and it’s unlike anything else ever done.

  • Part 1:  issues in the therapeutics drug discovery pipeline
  • Part 2:  medical devices and digital health
  • Part 3: described what we’re going to do about it.
  • Part 4: This Will Save us Years – Customer Discovery in Medical Devices
  • Part 5: Value proposition and customer segments in Life Sciences
  • Part 6: Distribution channels in Life Sciences
  • Part 7: Revenue Streams in Life Sciences
  • Part 8: When Customers Make You Smarter –Customer Discovery in Digital Health
  • Part 9: We’ve seen the Future of Translational Medicine and it’s Disruptive
  • Part 10: Lessons Learned in Digital Health
  • —–

    Sometimes teams win when they fail.

    Knox Medical Devices was building a Spacer which contained a remote monitoring device to allow for intervention for children with Asthma . (A Spacer is a tube between a container of Asthma medicine (in an inhaler) and a patient’s mouth.The tube turns the Asthma medicine into an aerosol.)Asthma

    Knox’s spacer had sensors for basic spirometry measurements (the amount of air and how fast it’s inhaled and exhaled) to see how well the lung is working. It also had a Nitrous Oxide sensor to provide data on whether the lungs airways are inflamed, an inhaler attachment and a GPS tracking device.

    Knox SpacerThe Spacer hardware was paired with data analysis software for tracking multiple facets of asthma patients.

    The Knox team members are:

    • Noel Jee, PhD in Chemical Biology at UCSF
    • Jingwei Zhang, PhD in BioEngineering at UCSF
    • Charvi Shetty, MS in BioEngineering, Genentech
    • Basil Ayish, MBA, Business Development
    • Clare Pak, Business Development
    • Allan May founder of Life Science Angels was the Medical Device cohort instructor. Alex DiNello CEO at Relievant Medsystems was their mentor.

      The Knox team was a great mix of hands-on device engineers and business development. They used agile engineering perfectly to continually test variants of their Minimum Viable Product (MVP’s) in front of customers often and early to get immediate feedback.

      Knox was relentless about understanding whether their device was a business or whether it was technology in search of a market. In 10 weeks they had face-to-face meetings with 117 customers, tested 33 hypotheses, invalidated 19 of them and 53 instructor and mentor interactions.

      Knox Medical’s 2-minute video summary is here

      Knox was a great example of having a technology in search of a customer. The initial hypothesis of who would pay for the device – parents of children with asthma – was wrong and resulted in Knox’s first pivot in week 4. By week 6 they had discovered that; 1) Peak Flow Meters are not as heavily prescribed as they thought, 2) Insurance company reimbursement is necessary for anything upwards of $15, 3) Nitrous Oxide testing isn’t currently used to measure asthma conditions.

      After the pivot they the found that the most likely users of their device would be low income Asthma patients who are treated at Asthma clinics funded by federal, state or county dollars. These clinics reduce hospitalization but Insurers weren’t paying to cover clinic costs nor would they cover the use of the Knox device. The irony was that those who most needed the Knox device were those who could least afford it and wouldn’t be able get it.

      Watch their Lesson Learned presentation here. Listen to the comments from Allan May the Device instructor at the end.

      In the end Knox, like a lot of startups in Life Science and Health Care, discovered that they had a multi-sided market.  They realized late in the class the patients (and their families) were not their payers - their payers were the insurance companies (and the patients were the users.)  If they didn’t have a compelling value proposition for the insurers (cost savings, increased revenue, etc.) it didn’t matter how great the technology was or how much the patients would benefit.

      The Knox Medical Device presentation slides are here. Don’t miss the evolution of their business model canvas in the appendix. It’s a film strip of the entrepreneurial process in action.

      Knox is a great example of how the Lean LaunchPad allows teams to continually test hypotheses and fail fast and inexpensively. They learned a ton. And saved millions.

      Lessons Learned

      • In medical devices, understanding reimbursement, regulation and IP is critical
      • Sometimes teams win when they fail