Digital healthcare companies often face a struggle, knowing where to start on the road to regulatory approval. Problems such as conducting clinical validation studies and finding the right regulatory experts to help with their journey can be major obstacles. These difficulties prompted Ruby Gadelrab to create MD interrupta California-based digital health intelligence company.

The company aims to help digital healthcare companies pursue regulatory approvals at an early stage by connecting them to a large network of experienced regulatory experts, including medical advisors, sales strategists and regulatory strategists. The company also helps companies get useful information about their technology from early clinical users.

This helps companies get data on the actual performance of their products in health conditions. MDisrupt’s long-term plans include setting up a benchmarking system for digital health technologies that allows different stakeholders to compare products by different criteria.

Medgadget had the opportunity to talk to Ruby Gadelrab about MDisrupt and his plans.

Con Hastings, Medgadget: Please give us an overview of the struggles that digital healthcare companies may face when seeking regulatory approval for their technologies.

Ruby Gadelrab, MD Disrupt: Digital health has the power to change the way 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 for innovation, as regulatory processes have not yet caught up with technology.

First, the boundaries between a medical claim (regulated) and a wellness claim are often blurred. It is difficult for digital healthcare innovators to clearly distinguish between each type of claim and the appropriate regulatory strategy to follow.

Second, regulators have tried to regulate software, algorithms, and AI in a similar way as they have regulated traditional hardware-based medical devices. This approach is not very suitable for the faster and more iterative processes required in software development.

Finally, the level of evidence and research required for regulatory applications is much higher for regulated health products than for consumer technologies. This means that digital health innovators need to figure out how to do the right technology and research for clinical validation, which is often a very different set of skills.

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

There is a constructive tension between digital healthcare innovators who want to “go fast and ruin things” and the healthcare ethos “does no harm”. At MDisrupt, we believe that if we can partner with digital healthcare innovators and relevant experts in the healthcare industry, they can “go fast and responsibly”.

Medgadget: How does MDisrupt help digital healthcare companies get regulatory approval at an early stage?

Ruby Gadelrab: MDisrupt has amassed a network of over 500 health experts who are available on request to work with digital healthcare companies. These experts include regulatory strategists who can help start-ups determine the regulatory path and work directly with regulators, medical advisers and chief medical officers, who can help define and design the studies needed for regulatory documents, and with trade and reimbursement strategists that can allow for widespread and large-scale.

Medgadget: How does MDisrupt help digital healthcare companies get real-world data on the usefulness, benefits and limitations of their products?

Ruby Gadelrab: Much of MDisrupt’s network of health experts consists of practicing clinicians who are considered to be early adopters of technology. These clinicians are digitally local and eager to embrace and test digital healthcare innovations in their practices. We call them clinical early adopters.

MDisrupt is able to take digital health products after marketing and place them in the hands of a group of practicing clinicians to test with their patients and compare them to standard care. We can systematically collect data from these clinicians on the effectiveness of the product in the real world, the experience of the provider and the doctor, the impact on health outcomes and feedback on the application in clinical work processes.

We call this concept clinical crowdsourcing. Clinicians gain early access to technology and have the opportunity to participate in the generation of data on digital healthcare innovation.

Digital healthcare companies receive valuable clinical feedback from consumers that can inform future product features and can create clinical advocates of innovation. In addition, the generated real-world performance data set can be used by other important health stakeholders, including payers, health systems, employers and other providers.

Medgadget: Please give us an overview of your plans to set up 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 in terms of productivity by generating clinically collected data.

Over the past two years, more than $ 50 billion has been invested in the digital healthcare industry. Digital health innovations today will become the healthcare of the future. This was demonstrated during the pandemic, when we relied on these healthcare technologies: this included telemedicine, covid tests at home, laboratory tests at home, remote monitoring of patients, and much more.

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

Our goal is to create a digital health intelligence platform where patients and providers can go looking for answers to these questions. And where more detailed data sets are available for payers to make reimbursement decisions, health systems and employers to make acceptance and enforcement decisions, and for investors to make medical investment decisions.

Medgadget: What inspired you to create MDisrupt?

Ruby Gadelrab: After spending over 15 years in Silicon Valley and leaving 23andMe in 2017, I consulted over 25 digital health companies for 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 technological, commercial or financial experience and experienced the same three challenges as the founders:

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

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

How do I generate the evidence I need for regulatory, supplier acceptance and scale?

These challenges have been consistent, regardless of the health product being developed.

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

It quickly became apparent that the first part of building a digital healthcare platform should be an application that connects health experts and clinicians with companies that need their experience. So, we started the company for a few years, while we had over 50 amazing clients, all using our health experts on demand.

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

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

Within 5 years, I hope that we have organized the world’s digital health products in terms of productivity and created an objective system of standards that everyone interested in healthcare uses to make healthcare decisions based on data.

Link: MDisrupt homepage…


Helping Digital Health Companies Win Regulatory Approvals: Interview with Ruby Gadelrab, CEO of MDisrupt

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