Helping Digital Health Companies Win Regulatory Approvals: Interview With Ruby Gadelrab, CEO Of MDis

Digital Health companies often face a struggle knowing where to begin on the road to regulatory approval. Issues such as conducting clinical validation studies and finding the right regulatory experts to assist in their journey can all present major hurdles. These difficulties prompted Ruby Gadelrab to create MDisrupt, a digital health intelligence company based in California.

The company aims to assist early-stage digital health companies to pursue regulatory approvals by connecting them with a large network of experienced regulatory experts, including medical advisors, commercial strategists, and regulatory strategists. The company also assists firms with obtaining useful information on their technologies from early clinical adopters.

This helps companies to receive data on the real-world performance of their products in a healthcare setting. MDisrupt’s long-term plans include creating a benchmarking system for digital health technologies, allowing various stakeholders to compare products across different criteria.

Medgadget had the opportunity to speak with Ruby Gadelrab about MDisrupt and its plans.

Conn Hastings, Medgadget: Please give us an overview of the struggles that digital health companies can face when pursuing regulatory approval for their technologies.

Ruby Gadelrab, MDisrupt: Digital health has the power to change how clinicians practice medicine, how they interact with their patients and how consumers and patients manage their health at home. Yet this area is one of the most difficult areas to innovate in as the regulatory processes have yet to catch up with the technology.

Firstly, the lines between a medical claim (regulated) and a wellness claim are often blurry. It is hard for digital health innovators to clearly distinguish what constitutes each type of claim and the appropriate regulatory strategy to follow.

Secondly, the regulatory bodies have tried to regulate software, algorithms and AI in a similar way to how they have regulated traditional hardware-based medical devices. This approach is not well suited for the faster and more iterative processes required in software development.

Finally, the level of evidence and the studies required for regulatory submissions are much higher for regulated healthcare products than they are for consumer tech. This means that digital health innovators need to navigate how to do the appropriate technology and clinical validation studies which is often a very different skill set.

Engaging regulatory experts early and often in the process can be the key to navigating some of these challenges.

There is a constructive tension between digital health innovators who want to “go fast and break things” and the healthcare ethos of “do no harm.” At MDisrupt we believe that if we can partner digital health innovators with the appropriate health industry experts they can “Go fast responsibly.”

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Medgadget: How does MDisrupt help early-stage digital health companies to secure regulatory approval?

Ruby Gadelrab: MDisrupt has amassed a network of over 500 health experts that are available on-demand to work with digital health companies. These experts include regulatory strategists that can help startups define the regulatory path and work directly with the regulatory bodies, medical advisors, and fractional chief medical officers that can help define and design the studies needed for regulatory submissions as well as commercial and reimbursement strategists that can enable widespread adoption and scale.

Medgadget: How does MDisrupt help digital health companies to obtain real-world data on the utility, advantages, and limitations of their products?

Ruby Gadelrab: A large part of MDisrupt’s health expert network consists of practicing clinicians who are considered to be technology early adopters. These clinicians are digital natives and eager to adopt and test digital health innovations in their practices. We call them clinical early adopters.

MDisrupt is able to take post-market digital health products and put them into the hands of a cohort of practicing clinicians to test with their patients and compare to the standard of care. We can systematically gather data from these clinicians on the product’s real-world performance, the provider and the physician experiences, the impact on health outcomes, and feedback on implementation into clinical workflows.

We call this concept clinical crowdsourcing. Clinicians get early access to technologies and have the opportunity to participate in the data generation for digital health innovations.

Digital health companies get valuable clinical user feedback which can inform future product feature development and can create clinical advocates for the innovation. In addition, the real-world performance data set generated can be used by other important stakeholders in healthcare including payors, health systems, employers and other providers.

Medgadget: Please give us an overview of your plans to establish a benchmarking system for digital health technologies. Who could benefit from this system?

Ruby Gadelrab: Our mission is to organize the world’s digital health products by performance through clinically crowdsourced data generation.

In the past 2 years, over $50B has been invested in the digital health industry. The digital health innovations of today will become the healthcare of the future. This was demonstrated during the pandemic when we relied on these technologies to deliver healthcare: this included telemedicine, at-home covid testing, at-home lab testing, remote patient monitoring and so much more.

The gap in the industry today is that there is no objective, data-driven, knowledge source that patients, providers and consumers can go to determine if a digital health product is good. Does it have evidence behind it? Who is the product suitable for? How does it compare to other products in the same category? What do clinicians think of it?

Our goal is to create a digital health intelligence platform where patients and providers can go to seek answers to these questions. And where more detailed datasets are available for payors to make reimbursement decisions, health systems and employers to make adoption and implementation decisions and for investors to make medically diligent investment decisions.

Medgadget: What inspired you to establish MDisrupt?

Ruby Gadelrab: After spending over 15 years in Silicon Valley and after leaving 23andMe in 2017 – I consulted for over 25 digital health companies over the span of 2.5 years. I saw some life-changing innovations in healthcare being developed and I met incredibly talented and passionate founders. All the founders I met had tech, commercial or finance backgrounds and they experienced the same three challenges as founders:

How do I find the right health experts to help me build my product?

How do I find the earliest clinical users of my product?

How do I generate the evidence I need for regulatory, provider adoption and scale?

These challenges were consistent irrespective of the health product being developed.

At the same time, there was a generation of clinicians who were looking to connect with the digital health industry and wanted to reduce clinical practice and participate in the development of digital health innovations.

It quickly became obvious that the very first part of building a digital health intelligence platform had to be an app that connected health experts and clinicians with the companies that needed their expertise. So, we bootstrapped the company for a couple of years until we had over 50 incredible clients all utilizing our health experts on demand.

Medgadget: Do you have any future plans for the company? Where do you see MDisrupt in five years?

Ruby Gadelrab: At MDisrupt we have built an incredible team of clinicians, scientists, engineers, technologists and commercial leaders. We have also built a thriving clinical community of experts and a client base. Our goal is to be the first point of call for any digital health innovator who wants to get their health product to market quickly and responsibly.

Within 5 years my hope is that we have organized the world’s digital health products by performance and created an objective standards system that every stakeholder in healthcare is using to make data-driven healthcare decisions.

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