Launching regulated SaMD and DTx in months – Mission Possible! Interview with Kal Patel, MD, CEO & Co-Founder of BrightInsight.

Digital health presented biopharma and medtech companies with an opportunity to design new commercial models by venturing into partnerships to accelerate clinical trials, offer personalized DTx, and improve adherence within the swim lanes of their core businesses. Leveraging digital technologies, minimizing risk and accelerating time to market in a regulatory compliant environment is crucial for staying ahead of the competition. We talked to Kal Patel, CEO & Co-Founder of BrightInsight, the leading global regulated digital health platform for biopharma and medtech, about how the company helps clients to accelerate regulated digital health innovation, their business and revenue models, as well as what is next for BrightInsight after closing recently a $101 million Series C funding round.

One year into the pandemic, we have seen the growing importance of digital health innovations and the use of software as a medical device to positively influence health outcomes in the real-world everyday moments. For biopharma and medtech companies using a regulated infrastructure to improve treatment experience, creating digital companions to enhance the outcomes that are driven by the traditional drug pathways, while minimizing the risk, accelerating speed to market, and transforming drug and device data into powerful real-time insights to demonstrate efficacy through data is crucial.

How can biopharma or medtech companies leverage technology to improve the real-world performance of a drug? How can these companies identify the right patient or undiagnosed or untreated patients at scale? How have AstraZeneca and Roche built their digital health innovations on BrightInsight platform and moved from project kick off to commercialization in less than a year?

To dive deeper into the value of digital in the regulated space and in the end-to-end product life cycle for pharma and medtech companies, we talk to Kal Patel, CEO & Co-Founder of BrightInsight, the leading global regulated digital health infrastructure for biopharma and medtech, that helps top clients accelerate time to market for their regulated digital health offerings including apps, algorithms, medical devices, combination products, or Software as a Medical Device (SaMD) across therapeutic areas.

Enjoy the interview!

Research2Guidance: Can you please briefly share BrightInsight’s story?

Kal Patel: BrightInsight was founded in 2018 with the mission to accelerate regulated global digital health innovation for biopharma and medtech. My co-founders, Ben Lee and Ferry Tamtoro, and I have spent our whole careers in pharma, medtech, and digital health. Based on this experience, we wholeheartedly believe digital health presents a great opportunity for biopharma and medtech to differentiate their therapies and improve patient outcomes.

I will take a step back for a minute to share what paved the way for the idea of our BrightInsight Platform.

Some years back, I founded and built Amgen’s Digital Health business unit in partnership with Ben and Ferry. During this time, we asked questions like, “How do we improve the real-world performance of our drugs? How can we leverage technology to help our drugs do a better job? How can we find the right patients?” We quickly learned that the real value was in leveraging digital technologies in the regulated digital health space and not in having an app, just for the sake of having something digital that no one downloads—or that people download, use once, and it forever lives in the graveyard of biopharma apps.

To give you an example, we put Bluetooth in a drug delivery device which led to Amgen getting the second-ever “connected combination product” approved by the FDA. It was a real advancement to have an injection pen embedded with connectivity, and with a backend platform. Our aim was to help unlock valuable patient medication data, in order to enable much more personalized adherence support.

Another example is algorithms. We recognized that many patients were misdiagnosed, undiagnosed, or under-treated. Helping to identify those patients at scale can be done by building algorithms, commercializing them, and obtaining regulatory approval. The key here is getting these algorithms embedded into the EHR, clinical distribution software tools, or patient registries to ensure physicians can easily leverage the data. We even embedded them into a medical device.

What we learned as we were addressing these high-value regulated use cases is that …

Yes, there are challenges in innovation, but we ended up spending more time, money, and effort trying to figure out the infrastructure on which to build these solutions.

When we founded BrightInsight we knew that “pharma and medtech were really moving into this regulated digital innovation space. Each company is trying to tackle infrastructure challenges on its own, and spending tens and tens of millions of dollars.” We saw a need for a global common infrastructure that is compliant with security, privacy, and regulatory requirements, and on top of which companies can build their innovations. That would allow them to focus on the patient, on the data, on turning that data into insights.

Research2Guidance: Interesting learning opportunities you had. In a way it really boils down to, “How can pharma /medtech commercialize and use digital to accelerate clinical trials, improve adherence, personalize DTx, etc.?” Can you share how your service offering fits in that?

Kal Patel: BrightInsight provides the leading global digital health platform for pharma and medtech companies to build regulated digital health solutions. We are helping our clients accelerate time to market for their regulated digital offerings – including things like apps, algorithms, medical devices, connected combination products, software as a medical device, and DTx.

Our platform enables our customers to launch game-changing digital health solutions quickly and in a compliant manner by replacing the need for lengthy and complicated ‘build from scratch’ implementations. Instead, we offer a pre-built and proven platform developed under a Quality Management System to support global security, privacy, and regulatory requirements.

We work across different disease areas including diabetes, respiratory, oncology, ophthalmology, and neurology, among others. To better understand the variety of our services, I will share two use cases / partnerships.

We recently announced a partnership with AstraZeneca and the launch of their AstraZeneca AMAZE Disease Management Platform, built on our BrightInsight Platform. In less than a year, we moved from project kick off to commercialization. Our platform significantly accelerated time to market through our pre-built functionality, including EHR integration with leading hospitals and health systems within the US.

Essentially what AstraZeneca’s team is aiming to do is to positively improve outcomes in patients across multiple chronic conditions such as asthma, COPD, heart failure, chronic kidney disease, and diabetes by providing end-to-end digital solutions that bridge the gap between patients and their healthcare providers. The solution addresses questions around how to deliver key insights at the point of care, how to bring data back to the care team, and how both of these steps can improve disease management.

Their platform has both a patient app and provider portal that integrates patient and provider user data into the clinical workflow via the EMR.

Another example is our partnership with Roche in Europe. We helped them launch, in just 6 months, a regulated Software as a Medical Device (SaMD) that is a more precise CE-marked dosing calculator app to treat patients with Hemophilia A, a rare disorder that stops blood from clotting. The SaMD empowers physicians to enhance and personalize different therapies. In this case, Roche’s digital solution enables doctors to input patient biometric data to determine the correct dose and administer based on approved dosing recommendations. This product deals with different aspects like patient safety and convenience. It is a great example of a digital tool that supports provider prescription and helps to improve and deliver personalized care.

The two examples we’ve just discussed are very different types of innovations that demonstrate the value of bringing regulated digital health solutions to market in the US and Europe quickly so that health outcomes can be improved.

Research2Guidance: The types of solutions that can be built on top of your platforms are myriad. What do you see as pharma and medtech’s biggest challenge?

Kal Patel: The biggest challenge for our clients is that they do not have a lot of expertise in regulated digital health. Digital health historically has been around behavior change, and on the non-regulated side of things.

If you take the typical pharma company, it has deep experience in the regulatory requirements for drugs and physical devices, and it might have a very robust and experienced IT organization. But the software they are building is not a therapy or directly attached to a therapy. And this intersection is very different and very complex. Building and commercializing that kind of SaMD is not in their wheelhouse.

Our clients are making great advancements taking data and turning that data into insights and then developing valuable algorithms. Where we come in is to partner with them and help them with what they are not good at, which is taking those algorithms, which are maybe sitting in a brilliant scientist’s laptop, and turning them into global software as a high-risk medical device.

It’s complex and can be overwhelming to develop, launch, and maintain regulated SaMD or DTx from a regulatory, privacy, and security standpoint, especially across multiple regions. BrightInsight is the key to manage these challenges end to end and through the entire lifecycle.

Research2Guidance: Forming partnerships to drive the innovation process is becoming a market standard. Your business model is B2B. What is your revenue model?

Kal Patel: Our business model is very much oriented around “How can we win together with our clients?” We license BrightInsight’s Platform on day one. We have invested, and continue to invest, tens of millions of dollars into our robust technology to support the development and launch of game-changing digital health solutions for our clients.

As our clients’ products come to market and are taken to multiple geographies, the user base scales, and so our license revenue grows as well. It’s an aligned business model that’s all about growing and being successful together.

Some of our clients also ask us to build their regulated software products on top of our infrastructure, like a typical professional services model.

Research2Guidance: You have recently secured $101 million in funding. Congratulations. What is ahead for BrightInsight?

Kal Patel: Yes, thank you. We raised a $101 million in a Series C financing round led by General Catalyst and with strong participation from our existing investors including Insight Partners, Eclipse Ventures and New Leaf Ventures.

This latest round will help to further fuel the already-explosive growth and momentum we’ve achieved in the last year. Our company has nearly tripled its employees and revenue, and we’ve nearly tripled our valuation to three-quarters of a billion dollars. With a total of $166M raised to date, we are excited about growing the company, our offerings, and our client roster in 2021 and beyond.

BrightInsight is the only proven and compliant digital health platform for biopharma and medtech on the market. The demand for our solutions and services has grown rapidly and we will continue to support our clients’ digital health product launches globally. This funding will help accelerate team growth and allow us to make further investments internationally and be present in more than 60+ countries across the Americas, China, and other Asian markets.

We will also enhance our already-robust BrightInsight Platform with prebuilt modules. And those prebuilt functionalities will enable easier customization and even faster time to market across these common use cases that we are seeing (patient engagement, connected combination products, dose management, disease management, etc.).

Research2Guidance: How has COVID-19 affected your business?

Kal Patel: On the macro level, the pandemic accelerated digital health across all healthcare stakeholders. And the same thing applies to us. Pharma companies and medical device companies are recognizing at all levels, from the board level to the CEO and all the way down, that the future is digital. And so now it is not a matter of “if” or frankly even “when” but at what speed do you start investing in and transforming your products /services around digital?

Last year, we saw again a tremendous amount of growth in the business, even as some of our clients’ priorities were changing because of COVID-19. Pharma companies started working on vaccines, as an example, working on therapies, and in all other ways their core business was affected. So, I would say that the pandemic created short-term focus changes for them, but in the medium term and already even in 2021, it has very much exposed the need and potential impact of digital across the industry.

Research2Guidance: What digital trends do you see in the pharma and medtech markets?

Kal Patel: The key trend we see is that pharma and medical device companies are recognizing the value of digital in the regulated space and in the end-to-end product lifecycle. Leading biopharma companies are starting to consider digital across the full cycle of product/drug development all the way through the commercial settings. For example, a Commercial team might partner with a Clinical Development team while they are developing a new Immuno-oncology therapy to in parallel build an algorithm to better match patients to the new therapy. Digital is no longer an after-thought.

My view is that in five years, pharma and medical device companies are going to incorporate digital at the beginning of a product development journey, as a standard practice—in the same way that today companies focus on formulations and drug delivery devices from day one.

Some of the leading companies are already doing this, and the ones who take it seriously will really win in the next generation of drugs and devices.

Research2Guidance: What do you find interesting and inspiring at this moment that we are in?

Kal Patel: I am excited about the time we live in and the future because I think we hit that inflection point in healthcare to really understand what the power of digital is. It is not going to be easy, and it is not going to happen as fast as we responded with COVID-19 vaccines, but it is hard to imagine that in 5-10 years we are not going to be in a very different world.

Years ago at Amgen, I saw that in healthcare the shortfall was not the technology, it was the application of that technology. I founded BrightInsight with the absolute belief that we need to drive the adoption of technology deeply into all aspects of healthcare and that will be a catalyst for massive transformation in health.

Some years ago, there were a relatively small number of people in healthcare that felt this way. Now, I would say that the industry is embracing digital technology at an exponential rate. Look at Moderna—a technology company that is known for applying robotics and AI to healthcare. It’s not a drug development company, yet they found a way to drive innovation and release vaccines in a short period of time. That’s what excites me.

Research2Guidance: Kal, thank you very much for this interesting conversation. We wish you and BrightInsight’s team to stay healthy and have a lot of success.

About BrightInsight

BrightInsight provides the leading global platform for biopharma and medtech regulated digital health solutions. When speed matters, we help companies accelerate time to market for regulated digital health offerings across therapeutic areas, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD). BrightInsight replaces the need for lengthy and complex ‘build from scratch’ implementations by offering configurable software modules and a proven platform built under a Quality Management System to support global security, privacy, and regulatory requirements. When building digital health products on the BrightInsight Platform, compliance is future-proofed as intended use changes scale across geographies.

For more information, visit BrightInsight’s website, Blog, Twitter, and LinkedIn pages.