Regulatory 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.
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. ●
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Medical Device Developments /
www.nsmedicaldevices.com
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