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On Patient-driven Innovation. Interview with Amy Tenderich

by Roberto V. Zicari on November 25, 2019

“We find ourselves in a new era of patient-driven innovation, which drives far better design and fosters collaboration between stakeholders.” — Amy Tenderich.

I have interviewed Amy Tenderich, journalist / blogger, well known patient advocate, and founder and editor of DiabetesMine.


Q1. You are one of the leading advocates for the diabetic community. In 2007, you wrote an open letter to Steve Jobs that went viral, asking Apple to apply the same design skills to medical devices that Apple devoted to its consumer products. What happened since then?

Amy Tenderich: There has been a true Revolution in Diabetes Technology and the “consumerization” of medical devices in general… and I’m thrilled to be part of it! As I laid out in my “10 Years Later” post, the biggest milestones are:

  • Upsurge of patient involvement in innovation/design
  • Shift to data-driven disease care that increasingly prioritizes Interoperability of devices and data
  • US FDA forging a path for open, candid interaction between the regulatory agency and the patient community – which we had a hand in (very exciting!)
  • Consumer giants like Apple, Google, Microsoft, Samsung and others getting involved in healthcare, and diabetes specifically — which changes the landscape and mindset for products and services

Q2. At that time you wrote that the devices the diabetic community had to live with were “stuck in a bygone era”, created in an “engineering-driven, physician-centered bubble.”  How is the situation now?

Amy Tenderich: With the help of our prodding, medical products are now designed to be more compact, more comfortable, more aesthetic and more personalizable than ever before. In other words, they’re now keeping pace with consumer tech products.

For examples, see the Tandem t:slim insulin pump and the One Drop glucose meter – which both resemble Apple products – the Quell pain relief solution, and the dynamic, fun-to-use MySugr diabetes data app.

Q3. Why is it so hard to bring the tech and pharma worlds together?

Amy Tenderich: Good question! Check out the 2012 Altantic article titled, “The Reason Silicon Valley Hasn’t Built a Good Health App.” It basically outlines how technology companies tend to focus on the tech itself, without understanding the real-world use case.
Also, tech companies tend to develop and iterate at breakneck speed, whereas the healthcare world – especially big legacy pharma companies – are burdened by loads of regulations and historically moved at a glacial pace.

The good thing is, these two worlds are inching closer together as:

  • Pharma companies are by necessity transforming themselves into digital organizations that deal in software and innovate more rapidly, and
  • Tech companies are “getting religion” on understanding the real-world aspects of people’s health and disease care.

Q4. Who are the key diabetes “stakeholders”?

Amy Tenderich: Patients and caregivers, first and foremost, as the people literally “living this illness.” Then of course: Pharma and Medtech companies, FDA regulators, clinicians, researchers, other healthcare providers (eg. Certified Diabetes Educators), non-profit advocacy groups, health data platform and app developers, and healthcare designers.

Q5. Artificial Intelligence and Machine Learning (ML) are becoming widely discussed and employed in the diabetes tech world. What is your take on this?

Amy Tenderich: Indeed, AI/ML appear to be the wave of the future. All data-driven tools for diabetes care – including new Artificial Pancreas tech on the horizon – is based on these advanced computing techniques.

Q6. When using AI for diabetes: what are the main new regulatory and ethical issues that need to be faced?

Amy Tenderich: We were fortunate to have Bill Evans, Managing Director of Rock Health, present on this topic at our 2018 DiabetesMine Innovation Summit.

His slide on “Seven Threats to AI” laid out the following:


  • Over-focusing on “shiny objects” vs. the UX and business value.
  • Smart algorithms are being trained on dumb and dirty data.
  • Practitioners are building “black boxes” even they can’t understand.


  • Though they’re the key customers, most enterprise organizations don’t know where to begin.
  • Major incumbents possess—but fail to capitalize on—the most valuable commodity: Data.

INVESTORS : Hype allows some companies to masquerade as “AI” companies.

REGULATORS : Regulation of AI/ML still needs to come into focus.

Evans and Rock Health have actually been instrumental in helping the US FDA decide how to approach regulation of AI and Machine Learning in Healthcare. Their work focuses on gaining consensus around “ground truth data.” You can read all about it and even weigh in here.

Q7. Which do you care more about: Accelerating medical advances or protecting data rights?

Amy Tenderich:  The hope is that these are not mutually exclusive. But if you ask people in the Diabetes Community, I believe they would almost always prioritize accelerating medical advances.

That’s because type 1 diabetes is a potentially deadly disease that requires 24/7 effort just to stay out of the hospital. Data privacy seems a small trade-off for many people to get better tools that aid in our survival and reduce the disease burden.

Q8. Many in the Diabetes Community are turning to DIY tech to create their own data-sharing tools and so-called Automated Insulin Delivery (or “closed loop”) systems.  Can you please explain what this means? Is it legal?

Amy Tenderich:  I’m proud to say that we at DiabetesMine helped launch the #WeAreNotWaiting community rallying around this DIY tech.

That is, the now-hashtag “We Are Not Waiting” was the result of a group discussion at the very first DiabetesMine D-Data ExChange technology forum in November 2013 at Stanford University. We gathered some of the early tech-savvy patient pioneers who were beginning to reverse-engineer existing products and develop their own platforms, apps and cloud-based solutions to help people with diabetes better utilize devices and health data for improved outcomes.

Today, there is a vibrant community of thousands of patients using (and iterating on) their own homemade “closed loop systems” around the world. These systems connect a continuous glucose monitor (CGM) with an insulin pump via a sophisticated algorithm that essentially automates insulin dosing. Current systems do still require some user intervention (so the loop is not completely “closed”), but they greatly improve overall glucose control and quality of life for patients.

These DIY systems have not been approved by FDA for safety and effectiveness, but they are by no means illegal. In fact, the results have been so powerful that no less than 6 companies are seeking FDA approval for commercial systems with the same functionality. And one popular DIY model called Loop has been taken up by an ­­­­outfit called Tidepool for conversion into a commercial, FDA-scrutinized product.

Q9 Is it possible to use Social Media for real Health Impact?

Amy Tenderich:  Most certainly, yes. There is a growing body of evidence showing real-world impact on improved health outcomes. See for example this recent eVariant article that cites the benefits of patient-powered research networks, and states, “There’s no question that patients use the Internet to take control of their own health.”

See also, original research from our DiabetesMine team, published in the Journal of Diabetes Science and Technology (Nov 2018): “Findings indicate that social media provides a significant source not only of moral support and camaraderie, but also critical education on thriving with diabetes. Importantly, we observed strong evidence of peer influence on patients’ therapy and diabetes technology purchasing decisions.”

Q10 What is the FDA mHealth Pre-certification Program?  and what it Means for Diabetes?

Amy Tenderich:  This is the FDA’s revolutionary move to change how it reviews mobile apps and digital health software to accelerate the regulatory process and get these products out there for people to start using ASAP.

The agency announced its Pre-Certification for Software Pilot Program in July 2017. Its role is to evaluate and dub certain companies as “trustworthy,” to fast track their regulatory review process.

For the pilot, the FDA chose 9 companies out of more than 100 applicants, and notably for our Diabetes Community: seven of the nine companies have direct ties to diabetes!

See our coverage here for more details.

Qx Anything else you wish to add?

Amy Tenderich:  We find ourselves in a new era of patient-driven innovation, which drives far better design and fosters collaboration between stakeholders. There are so many exciting examples of this – in telemedicine, at the Mayo Clinic, and at Novo Nordisk, to name just a few.


Amy Tenderich photo

Amy Tenderich

Amy is the Founder and Editor of, a leading online information destination that she launched after her diagnosis with type 1 diabetes in 2003. The site is now part of San Francisco-based Healthline Media, where Amy also serves as Editorial Director, Diabetes & Patient Advocacy.

Amy is a journalist / blogger and nationally known patient advocate who hosts her own series of thought leadership events (the annual DiabetesMine Innovation Summit and biannual DiabetesMine D-Data ExChange) that bring patient entrepreneurs together with the medical establishment to accelerate change.

She is an active advisor to the American Association of Diabetes Educators (AADE) and medtech consultant, along with a frequent speaker at policy and digital health events.

As a pioneer in the Diabetes Online Community (DOC), Amy has conducted numerous patient community research projects, and authored articles for Diabetes Spectrum, the American Journal of Managed Care and the Journal of Diabetes Science and Technology.

Amy is also the proud mom of three amazing young adult daughters. In her “free time,” she enjoys hiking, biking, leisure travel, good wine and food, and just about anything relaxing done under the California sun.



Related Posts

–  On gaining Knowledge of Diabetes using Graphs. Interview with Alexander Jarasch, ODBMS Industry Watch, February 4, 2019.

–  On using AI and Data Analytics in Pharmaceutical Research. Interview with Bryn Roberts  ODBMS Industry Watch, September 10, 2018

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