Bringing Digital Health Products to the Global Market

By MedTech Intelligence Staff
October 25, 2023


• Categories: 01-Digital Health, 05-Quality/Regulatory, Clinician Engagement, Digital Therapeudics, RC - EU MDR and IVDR, Regulatory, SaMD

In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine Society (DiMe), to learn more about the society’s new Healthcare Product and Policy project aimed at sorting out the different regulations in place and on the horizon to help developers be more efficient as they design their clinical trials and investigate pathways to market for their innovations.

What is the Digital Medicine Society, and what are its goals?

Coder: The Digital Medicine Society is a global nonprofit that was founded in 2019. It has a number of different focuses, but everything ties back to advancing the ethical, effective, equitable and safe use of digital medicine. DiME takes a scientific approach to everything it does, and a lot of this is based on research and how to move toward broad acceptance of these technologies that have been validated and can impact patient care in a positive way.

The different verticals we have are: Digital Diagnostics and Measures; Healthcare Product and Policy; and then we also have a Healthcare Delivery vertical that is focused on virtual-first care. We are also involved with Cancer X, which is a partnership hosted by the White House and DiME. I work in healthcare product and policy.

What are some of the key challenges for companies that are developing digital health technologies due to the lack of a harmonized standard or regulatory framework?

Coder: It creates a very unique ecosystem where we have technologies that have the ability to scale across borders, yet borders and jurisdictional requirements exist. So how do we navigate within that?

A lot of decision makers are really excited to embrace this new category and they are looking forward to providing patients with new care opportunities, but without reference points that they can go back to, they feel they need to make up the requirements on their own. This includes, what kind of data requirements are we looking for, what kind of clinical evidence requirements are we looking for, and what do we count as good and sufficient and safe and effective? There are some mechanisms in place—the FDA and other global agencies have addressed the safety and efficacy side, but there is a lot to be figured out in terms of what is good and sufficient.

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From a company standpoint, they are trying to figure out—relative to different markets—what studies they need to conduct. Validation is central and critical to everything these companies do and the lack of guidance on where to head with that is a big challenge. Additionally, applicability of those studies across multiple pre-market evaluation phases is an issue.

What we’ve noticed—and it’s what we’re going to be addressing with this project—is that requirements that may be acceptable in England, for example, for the initial MDR or MHRA certification, may be different than those that are required by NICE, which are different than what are required by NHS, which are different than those of the local jurisdiction.

Not only does the company need to look at what studies they should be conducting, they need to know how many sets of studies for how many different entities in the decision-making process.

How will this project help companies overcome this challenge?

Coder: We’ve brought together a good number of partners and we’re going to be convening to address these challenges. The first step is to identify the main regions that have a market access pathway in place. What we recognize is that some countries have regulatory pathways, so the device can get clearance of some sort showing that it is safe and effective. But they may not have an actual path to market for patient care.

So, we’re first identifying countries that have that full spectrum of regulatory and patient access opportunity. Within that group, we’re going to look at the evidence requirements for each of those phases of decision-making pathways or processes.

In Europe, for example, you need to go to the national country level agency to register and then be evaluated—what are those requirements? Then we’ll start to do cross comparisons and analyses between countries within a single region and then between different regions. We’ll look at whether you can take data for a specific pathway in England and then apply them to Germany, for example.

How do these differing global regulations affect the healthcare delivery organizations that want to adopt these technologies?

Coder: This is where the global aspect becomes super interesting and somewhat complicated. What we’ve noticed within just the initial mapping processes that we’ve done is, Germany, for example, has a pathway called the DiGA pathway for digital health technologies. What’s interesting about their pathway is that if you are successful in the evaluation process, you are then given market access to the full national population within Germany. It is authorization for full access. But there have been some issues. The German regulatory ecosystem was so focused on developing that pathway, they didn’t bring the healthcare systems and clinicians in early enough. They made full national availability and the physicians on the back end said “What?!?’ So we know the pathway is valuable but we have not been able to demonstrate full update because they are still onboarding clinicians.

A good example on the other end is Europe, where you can go through MDR or MHRA to be shown as safe and effective. Then you go to NICE and NHS (within England) to get your recommendations on what applicability could look like nationally. Then companies need to go to every single local commissioning ecosystem to get patient access. As a result, the implications for hospitals and healthcare systems are going to be completely different based on whether automatic access is provided or is being negotiated region by region, and the complexities of that add up very quickly.

How do concerns with interoperability affect regulatory decisions and/or healthcare delivery organization uptake?

Coder: We’re hearing different reports from different health systems on what they want to see. I was in Estonia a couple of weeks ago and one of the health systems there was saying that one of their products that had the easiest integration and utilization and the broadest uptake in the system was actually one that did not need to be incorporated into the electronic health records within the system. It just made it easier for doctors to engage and made it easier for patients to download and use the product and derive the benefits without integrating into the EHR.

Other health systems say this is non-negotiable; it needs to be part of the ecosystem, and it needs to be just a few clicks for a clinician to enter it in EHRs. There are different opinions from different systems on what is the product, who is the indicated patient population, who is the clinician population and what is the intended use. Nothing is one size fits all in this ecosystem. But, for the most part I hear that interoperability is something people would like to see more of, and given how many health records exist within a single region much less globally, that will be a challenge for a long time.

When it comes to global regulatory harmonization, is there anything that is working in favor of the developers?

Coder: We’re talking about clinical trials right now, and there are a number of products that have done a number of clinical trials to demonstrate outcomes. They have demonstrated safety and efficacy, usability and short and long-term clinical impact. So the good news is, we know we’re dealing with products that can be validated and can show impact that patients can trust.

What we’re focusing on in this project is how to create some harmonization and consistency to make sure that patients can benefit from these technologies. I have seen broad enthusiasm. The fact that healthcare systems are as motivated as they are to create their own pathways, that regulatory systems are looking at this, that payer systems are looking at this and developing entire pathways. and the fact that South Korea alone within six months put together a pathway for digital therapeutics after COVID—all these things demonstrate the growing global understanding that this is a critical new category of medicine that needs to be fully integrated into healthcare systems. Now it’s time to say, let’s all work together to create consistency and clarity and enable scalability.

What are you developing in terms of resources that will be available to manufacturers?

Coder: We want to create a tool that manufacturers can use to identify what types of studies they have created and what types of studies they need to create in order to enter into multiple markets. In short, we want to create a tangible tool that manufacturers can use to assess what they already have and what they need to increase efficiency, so they can focus their resources on the patient care aspect as opposed to redoing clinical studies every single time they go to a new decision-maker.

The second component is, we’re putting together case studies that include real-life stories from companies that have gone through these pathways. We want to understand, for example, if these are all case-by-case determinations and what impact does that have if every country says, we realize there needs to be a fit for purpose pathway in place, just come to us and we’ll discuss it. I think that will help the manufacturers identify best practices and help policymakers identify where they can create more clarity and consistency in setting up their own pathways.

Are you doing any advocacy work with the regulatory bodies to help them create more harmonization and set up clear pathways?

Coder: We are a 501(c)(3) organization, so we do not do policy in the traditional sense. DiME does not lobby. We look at what the regulations are, and what the pathways and policies are. Then we assess and analyze them and share that as an educational tool.

The digital medicine companies know that a lot of the building blocks are in place. At this point, it is a matter of sorting through those building blocks, identifying where best practices and commonalities may be, and then helping companies and manufacturers align on what those building blocks should be to create a strong foundation for approval and access that can cut across regions.

When we talk about harmonization, I personally believe we can have some consistency and harmonization at one level, but every single country will still—and ought to—make its own determinations based on the data. The requirements can be consistent in terms of the expectations for companies going into these pathways, but we fully appreciate that every single country will make their own determinations based on needs of their population and what their goals from a patient population health perspective. So consistency is critical but we’re also making sure that country autonomy is represented and respected the entire way through.