In today’s global healthcare systems, marked by challenges related to access, equity, affordability and outcomes, the rapid stride of digital health innovation holds immense potential. However, the combined pressures of delivering innovative patient care and balancing existing regulatory pathways mean that manufacturers do not have the luxury of wasting time or money on pursuing multiple regulatory strategies for a single product line. Furthermore, manufacturers cannot evade the imperative of pursuing a regulatory strategy when in reality it should be a foundational consideration from the outset.

A recent survey conducted by the Digital Medicine Society (DiMe) revealed that 25% of digital health product manufacturers did not know if the product they are developing was regulated or not. Of those respondents who knew their product was regulated, 75% did not know the optimal pathway to pursue. Recognising this void, the DiMe undertook an effort to develop a suite of tools and resources to clarify the US regulatory pathways applicable to digital health products, in addition to highlighting the benefits and considerations associated with each potential pathway.

If not now, when?

Regulatory oversight can offer digital health manufacturers a robust path to demonstrate product safety and efficacy. Fit-for-purpose regulatory strategies that account for review timelines, costs, evidence-generation requirements and compliance measures can expedite digital health product clearance and market entry. It can also enable products to qualify for certain additional reimbursement pathways, thus leading to market access impacts downstream, increased product acceptance, and improved patient outcomes.

A key step to building a regulatory strategy is classifying the digital health product’s target market, product claim, and benefit-risk profile. This will determine the appropriate level of regulatory oversight the product will be subject to. To provide manufacturers with regulatory pathway clarity and enable greater commercial success, DiMe partnered with industry experts in a pre-competitive collaboration called Digital Health Regulatory Pathways. This multi-sector collaboration brought together experts from academia, clinician associations, tech and pharmaceutical companies, as well as the FDA, to develop a suite of 50-plus resources that directly support innovators who are seeking to optimise their regulatory strategy.

Navigate, don’t speculate

The recently launched, interactive, open access U.S. RegPath Tool enables manufacturers to adeptly navigate the intricate US digital health product regulatory pathways, guidelines and regulations. The RegPath’s five-step approach aids manufacturers in classifying their digital health products in the US through tools such as the product categorisation guide, the product classification map and a risk-based assessment model to help manufacturers ensure that products are developed and launched successfully, with any issues being addressed in a timely and effective manner.

As part of the interactive tool, manufacturers initiate the process by answering a few questions about their product to determine if it qualifies under an existing FDA regulatory pathway. If the product – in full or in part – is regulated, the tool identifies for manufacturers how they can identify its function, product class, and optimal regulatory pathway. Additionally, once manufacturers identify the proper regulatory pathway, they have access to toolkits that contain resources related to initiating the appropriate application.

For example, if users learn that their product is likely to undergo FDA’s 510(k) pathway, the toolkit contains resources related to the 510(k) pathway at-a-glance, a 510(k) preparation guide, a 510(k) checklist, and an FAQ document to help manufacturers navigate critical next steps.

The U.S. RegPath Tool also features the Library of Digital Health Regulations, a crowdsourced library of US regulations and guidelines that apply to digital health clinical research and clinical care products. The library enables manufacturers to efficiently filter and search through various US regulations and guidance. Over the next year, additional resources will continue to be added to the collection to help manufacturers pursue and optimise their regulatory, evidence generation and business strategies across multiple global markets and regions.

A well-thought-out regulatory strategy can proactively demonstrate a product’s safety, effectiveness, and quality to patients, clinicians, and payers. Tidepool Loop, for example, is a closedloop automated insulin delivery system intended for the management of type 1 diabetes. The product received 510(k) clearance from the FDA in January 2023, but prior to then, patients used DIY looping instead of an FDA-cleared product when they needed to automate insulin delivery and reduce the burden of type 1 diabetes.

Tidepool created a strategy to build a product that delivers an FDA-regulated version of the unregulated DIY Loop app(s), thus making it broadly available for patients to download via the iOS App Store. Receiving a 510(k) clearance, Tidepool Loop became recognised as a Class II medical device and the first fully interoperable automated insulin dosing app intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps. These technologies work in tandem to automatically increase, decrease and suspend delivery of basal insulin based on iCGM readings and predicted glucose values.

Evolve strategy as products evolve

Products will continue to evolve and iterate even after manufacturers build their initial regulatory strategy. Manufacturers therefore face the question of whether products need to go through the full regulatory process again, versus following an expedited pathway, or not. A good regulatory strategy accounts for future product iterations and changes from the outset.

Take for example, Caption Health’s Guidance software, the first cardiac ultrasound software intended to assist medical professionals in the acquisition of cardiac ultrasound images. It is an FDA granted Class II medical device via the FDA’s De Novo pathway. As part of their regulatory strategy, Caption Health identified the product’s current (and future) product claims, communicated with the regulator, and as a part of their De Novo submission, obtained regulatory approval for a Predetermined Change Control Plan (PCCP). The PCCP allows manufacturers to make certain changes without needing a new regulatory submission. Caption Health used its approved PCCP to port the guidance software to new hardware platforms, as well as to optimise its algorithms without needing additional regulatory submissions – saving time, money, and manpower resources.

Regulatory uncertainty in the rapidly evolving landscape of digital health technologies has often deterred innovators from working with the FDA. With emerging modern-day software-based technologies – such as digital diagnostics, extended reality, AI or machine learning-enabled medical products – there is an elevated pressure for the regulator and industry to innovate in the gray space of evolving regulation. Yet, among such uncertainties, especially when the existing regulatory paradigm may seem cumbersome or overwhelming, there is an undeniable positive value for manufacturers engaging with the agency.

Action for the future

To advance the development of regulatory science, strategy, and policy, DiMe recently shared new findings on the industry’s digital health regulatory needs, highlighting manufacturers’ top priorities of action for the FDA and industry to make forward collaborative progress. To address some of the challenges, DiMe’s upcoming project, integrated evidence plans (IEP) for digital health products, is bringing together leaders in digital health product development, regulation, reimbursement and commercial strategy with payers, purchasers, policymakers, clinicians and patient groups to identify core components of an integrated evidence plan.

The IEP project will help answer the question of how manufacturers can achieve broad patient access to their products’ benefits and commercial viability. It will be modular to allow manufacturers of any regulated digital health product to design a single, consolidated evidence-generation strategy to satisfy the needs of all downstream stakeholders, including US regulators, payers, purchasers, clinicians, and patients. The goal of the IEP project is to accelerate time to market and ensure faster access to patients in need and support the clinical and economic value of products.

Well-crafted regulatory strategies are the linchpin to the development and success of digital health products. It not only accelerates time to market but also ensures swifter access to patients in need while bolstering the clinical and economic value of these innovative products. The more knowledge and preparedness manufacturers possess, the greater their chances of bringing transformative solutions to the healthcare landscape, benefiting both patients and the industry at large.

RegPath Flowchart

Manufacturers can access a non-interactive version of the U.S. RegPath Tool through the U.S. Regulatory Pathways Flowchart. To optimise flowchart navigation, manufacturers should aim to answer these five questions:

  • Who: is the end user of the product?
  • What: does the product intend to do?
  • When: should the end user utilise the product?
  • Where: will the product be used?
  • Why: should the end user use the product?

Digital Medicine Academy

DiMe has convened leaders from across the industry to collaborate on resources and guides to help navigate the current uncertainty. The newest education course from its growing Digital Medicine Academy is ‘Unlocking regulatory success for digital health product developers’. This course teaches product manufacturers why and how to build robust regulatory strategies that will in turn strengthen their organisation’s business strategy, differentiate products and build trust among their consumers in today’s competitive digital health market. Specific course objectives include:

  • Identify whether digital health products in their portfolio are likely to be regulated and through which mechanisms.
  • Build a regulatory strategy, sufficient knowledge to implement that strategy, and be positioned to advance the success of their digital health product portfolios.
  • Develop evidence-based, high-quality products and reduce their dependency on regulatory consultants.