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How we make digital health work

A conversation with Kal Patel, MD, senior vice president of Digital Health at FLEX.

 

How does FLEX engage with healthcare?

At FLEX, we offer services that support a product at any point in its lifecycle, from engineering and prototyping to automating manufacturing. We support 12 different industries including healthcare, giving us a unique vantage point, and see them all evolving their businesses for the connected world we live in.

Within healthcare, we’re focused on helping companies connect medical devices and turn the data that’s captured from those devices into actionable insights that can have a measurable impact.

What are some of the problems with the current digital health landscape?

When you look at the marketplace today, you see a lot of siloed solutions that operate on their own, and that don’t integrate seamlessly with how we live. For example, as my plane was coming in for a landing today, my wearable fitness tracker told me it was time to get up and walk around. It just didn’t have any context for, or consideration of, what I was doing at that exact moment in time.

Until you have that contextualization, it’s hard to deliver insights at the appropriate time and in the appropriate way, when a person can take action. And when digital health solutions fail in the real world you lose engagement, and over time, people start ignoring them.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

One of the other challenges with the current digital healthcare landscape is the disparity between product development lifecycles on the pharma side and on the technology side. Pharma is not used to, or comfortable with, the concept of a minimum viable product (MVP). When you’re used to spending 10-15 years and billions of dollars developing something, launching an MVP digital health solution is challenging and can take years of organizational alignment. There are regulatory management models that will alleviate these challenges and streamline pharma’s ability to digitize their solutions. We think of digital as a way for pharma companies to continuously improve their drugs, devices or combination products, across multiple brands, beyond their initial go-to-market launch.

Despite the promise that digital health holds for pharma and medtech companies, there are two main stalling factors – regulatory hurdles and the perceived Return on Investment (ROI). While the regulatory environment can be a challenge, pharma and medtech companies have to embrace it, and not use that as an excuse to not innovate.

Related to that, the second reason pharma and medtech companies are slow to adopt digital technologies is a rather narrow view of the ROI. Many pharma companies look at an investment in digital as a budgeting tradeoff between another TV advertisement or being able to hire additional sales representatives. We’re working with pharma companies today to help them think about the potential returns that digital health solutions enable in the near term, such as improved adherence and market-share, as well as the returns down the road, such as being prepared to operate in a connected world with entirely new business models. And the ROI may not be what pharma companies are looking for right out of the gate. Coming from the pharmaceutical industry myself, I understand that this is a hard concept to swallow. With digital, the first version of a solution is often going to be the worst version. But you keep iterating and updating. Success for a new digital health app can be merely working from an operational perspective for consumers. The second version of success could be improving adherence slightly. It may take until the third or fourth iteration until pharma companies see significant ROI from an adherence perspective, and pharma needs to be comfortable with that.

I often liken the healthcare industry to the automotive industry. If the auto industry took a narrow-ROI view with immediate returns, would any manufacturers be working on autonomous vehicles? It took disruptors like Google to catalyze them into investing in digital technologies. Similarly, if pharma and medtech companies don’t embrace digital now, they’re opening the industry up for disruptors.

At the end of the day, we believe that digital innovation is more disruptive, less risky, and has a higher likelihood of success than the traditional drug innovation model.

How is FLEX creating breaking down the silos that exist in healthcare today?

We’re building one of the first regulated, therapeutic digital health platforms, which will have the design controls and quality systems to optimize class I, II and III medical devices, as well as combination products (e.g. combo drug and drug-delivery device like an auto-injector). Deployed as a managed service, our platform, BrightInsight by FLEX, has an open, secure architecture that will enable data to be captured, integrated and analyzed from multiple apps, devices or drugs, ultimately delivering insights to pharmaceutical or medical device companies that they’ve never had before. All of the data will be linked to one system, allowing companies to add multiple solutions onto the platform for a truly holistic view across their patient populations.

We’re also working with the largest and most advanced technology players to enable digital health experiences to meet the consumers where they are. With a patient’s permission, and the artificial intelligence expertise of our technology partners, we can contextualize data to deliver insights to patients in the right place, at the right time and in the right way.

Imagine medication reminders being delivered from your Google Home or Amazon Alexa, as opposed to yet another siloed app.

How do we get physician buy-in?

The first thing to tackle is ensuring that your solutions fit within the clinical workflow. When I was in medical school, we had an EMR, but every time I wanted to see an x-ray, I had to minimize it and launch a separate application. If I wanted to see a CT or MRI, I had to walk ten minutes to radiology. Now, all that can be surfaced in the EMR.

The same thing has to happen in digital health. As long as you have insights coming from a device, no matter how great the insight, we’re not going to get widespread adoption by physicians until we integrate the data into their clinical workflow. In the future, your clinician should be able to see all these disparate pieces of information in the EMR, including data from your devices and apps.

How do these tools help/challenge pharma?

The pharmaceutical industry has a lot of challenges with their products once they get them to market. For example, they cannot see what happens to that drug after the prescription has been filled. They don’t know how many prescriptions were written, if the patient is taking the drug, or if they’re taking it correctly. By the time a clinician or pharmaceutical company finds out a patient is off of a drug through claims data, it’s usually three months later. It’s highly unlikely at that point that a pharmaceutical company can engage the consumer again and capture more prescription refills.

This is a big deal because the healthcare industry is currently spending $250 billion a year due to poor compliance. The industry is realizing that if they make their delivery devices smart, they can track utilization in real-time.

Verifying compliance would also be a huge asset for clinical trials. They could speed up their trials, collect more accurate data and, since compliance would be higher, recruit fewer people. What could be more frustrating than seeing a drug fail and not actually knowing what percentage of patients actually took it?

The longer pharma just dabbles in this, the greater the chance they will be disrupted by an outside company. But it’s a difficult transition. The industry is used to ten or fifteen-year product life cycles in a very regulated environment, and now they have to shift to a digital environment. It’s not their culture. They’re not used to figuring out software or collecting patient data and thinking about whether it’s secure. These are things we are trying to address.

What’s FLEX’s vision for digital health?

We want to enable visionary pharmaceutical and medtech companies to go from taking that 10 to 15-year conservative approach to realizing there’s a lot of public health, as well as shareholder wealth, to be created by embracing digital solutions.

How do you connect data in a way that meets all the requirements from regulatory, privacy and security perspectives? At FLEX, we are enabling that functionality in a plug-and-play way. We can reduce the size of the mountain that pharma and medtech need to climb to implement these digital solutions.

 

Kal Patel, MD, SVP of Digital Health at FLEX, has held a variety of leadership roles across biopharma, healthcare delivery and digital health. Kal served as Chief Commercial Officer at Doctor on Demand where he was responsible for all business and commercial functions. Prior to Doctor on Demand, Kal founded and led Amgen Digital Health and was previously Head of Corporate Strategy as well as Global Marketing Lead for Amgen’s leading drug, EnbrelTM. Kal has also held leadership positions at Novartis and The Boston Consulting Group. Kal has a Bachelor’s degree in Economics, an MBA and an MD from the University of Chicago.

 

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