Anand Iyer, Ph.D., MBA, is a global digital health leader well known for his experience and expertise with technology, strategy, and regulatory policy. Dr. Iyer is WellDoc’s Chief Strategy Officer. He’s considered a visionary in this field and has played important roles in utilizing his novel thinking and deep expertise to move digital health forward. During 2017 he was excited to see two initiatives he played an integral role in launch – the U.S. Food and Drug Administration (FDA) Software Pre-Certification Program (Pre-Cert) and the Digital Therapeutics Alliance (DTA) for which he’s a founding member of the board of directors.
Dr. Iyer shares his perspectives about these recent milestones in this Insights interview.
Can you capture the U.S. and global status of the adoption of digital therapeutics as a tool in healthcare delivery and chronic disease management?
Dr. Iyer: Let’s frame this topic in two phases: feasibility and viability. For years, we’ve been grappling with feasibility of digital therapeutics. In essence, feasibility is proof. Does the digital therapeutic accomplish the goal and what benefits does it achieve? Proof comes from clinical trials, positive evidence, patient engagement and more.
Then there’s viability or scalability. The key question is: Can this evidence-based digital therapeutic be scaled to make it operational? Viability must consider the integration into patient care workflow, how medicine is practiced, use in an array of population segments, across multiple disease states, multiple languages and more.
At this point in the US, entities in digital health are at that phase 1/phase 2 cusp. We’re stuck at the end of phase 1 and are dying of pilot-itis. No one has figured out how to get to phase 2. The rest of the world is still in phase 1 asking will it work? However, there’s an interesting exception in countries that have no IT legacy or history and are smaller economies and geographies. They’re already in phase 2. They “leap-frogged” to go all digital from the get go. This has happened in countries like Singapore, South Africa, and Israel.
What’s the significance of the Digital Therapeutics Alliance (DTA) launch in late 2017? What entities are involved and what are the Alliance’s initial goals?
Dr. Iyer: Let me apply a wider lens for a moment. In Professor Charlie Fine’s book Clockspeed, he presents the “double helix” concept – that is, the natural ebb and flow between a nascent, vertically-integrated industry and a mature, horizontally-modular industry. Think IBM PC. MA Bell. Think of how they’ve formed, broken up, and re-formed. Why did this occur? First, customer knowledge. They don’t know enough and thus aren’t able to adopt. So you have to do all the heavy lifting which includes vertically integrating everything they need into a “turnkey” solution. But, next there’s the need for industry standards and regulations. Then competition. Then pressure to dis-aggregate.
Apply this “double helix” concept and the application of a turnkey solution to what’s happening in digital therapeutics today. We’re at that tipping point! Getting to the other side of the helix requires collaboration across an industry and regulatory entities to create standards. This can give rise to increased competition. That expression, “all rise with the rising tide” applies to our current scenario and the rationale for the DTA. Simply, it will move the industry forward, faster.
The initial goals of DTA is to define what’s needed to move the industry forward around the globe, to define a common taxonomy and nomenclature and to help the FDA’s Pre-Cert Program. This includes standard toolkit stuff: request for proposal templates, how to structure randomized controlled trials, how to measure patient engagement and more. This will give the industry standards to achieve scale or viability.
Why did Welldoc become a founding member of the DTA?
Dr. Iyer: Simple. We’re one of the few companies who have the experience and who’ve done it!
Other founding members are Akili, Pear, Voluntis and Propeller. Together we’re the healthcare industry’s leading manufacturers of clinically validated digital therapeutic solutions that:
- have been clinically evaluated, in multiple published studies conducted by third parties;
- are cleared by the regulatory authorities;
- follow cyber best practices;
- support both providers and patients; and
- deliver healthcare value – outcomes and economics.
What are the basics of the FDA’s Pre-Cert Program and its significance?
Dr. Iyer: Pre-Cert embraces the principle that certain digital technologies provide significant benefits to patients’ lives by helping them manage chronic conditions outside of traditional healthcare settings, as well as supporting providers, healthcare systems, and payers by facilitating disease prevention, diagnosis, and treatment.
The program has five pillars:
- Patient Safety;
- Product Quality;
- Clinical Responsibility;
- Cyber Responsibility;
- Proactive Culture
Around each pillar there are industry accepted Key Performance Indicators (KPI) – best practices and tools. For Pre-Cert if an entity can demonstrate the ability to meet the KPIs, they can qualify to attain Pre-Cert status. This means the company, rather than each and every product iteration, goes through the FDA regulatory process for clearance providing that the company continues to produce digital therapeutics with similar risk profiles. At this point the intention of FDA’s Pre-Cert program includes lower risk digital therapeutics, so class two devices, not class three.
The significance to Pre-Cert is simple. It’s designed to transform the regulatory process from a barrier to an enabler, an accelerator. It modernizes the process and makes it agile. Learn more about FDA’s Pre-Cert program.
How will DTA help move the needle on FDA’s Pre-Cert Program?
Dr. Iyer: Pre-Cert enables FDA to certify companies that design and manufacture regulated processes that are well-suited for the iterative software design, development, validation, and maintenance critical for digital therapeutic manufacturers. So rather than just providing a view of what the architecture looks like for single company, DTA will provide a consolidated view of what it looks like from the vantage point of 5 companies. It will already be vetted across companies and digital therapeutic domains.
How do you envision DTA growing and expanding globally?
Dr. Iyer: The growth has the potential to be exponential. There will be work groups focused on different areas such as
: toolkits, templates, analysis frameworks, benchmarking and data analysis and lastly the development of new global chapters. Learn more about DTA.
Can you look into your crystal ball and envision how digital therapeutics will evolve and make their impact in the triple aim of healthcare delivery in five years, ten years.
Dr. Iyer: All digital therapeutics will demonstrate their impact on the triple aim. This is fundamental to the definition of the DTA. They’ll have their impact in a variety of ways including to:
- augment traditional chronic disease therapies. For example you might see Welldoc’s BlueStar used to increase adherence and persistence to glucose lowering medications.
- be stand-alone therapies. For example Akili’s product in the management of ADHD.
- introduce new therapies into care systems at much faster “clockspeeds.”
- renew the marketplace. The refresh rate of products into the market will multiply by 10 fold.
- offer customization and personalization an era of precision medicine/ therapy.
We’ll evolve to the notion Eric Topol, MD, put forth in his book, Yes Doctor, The Patient Will See You Now. Topol conjectures that in time people will see their providers when and how they need. The setting in which interactions occur will be patient-centric, based on the person’s needs and preferences. Overtime technology will democratize healthcare.