By David Hawkins, CTO and Co-Founder, Sotas

The life sciences and medtech sectors are undergoing rapid transformation. Innovations in digital health, artificial intelligence, regenerative medicine, and connected diagnostics are reshaping patient care and treatment pathways. However, innovation increasingly runs ahead of regulation. Emerging technologies often face unclear or incomplete regulatory frameworks, creating new strategic and operational challenges for organisations.

At Sotas, we support innovators across all stages of the development lifecycle, from early concept through to commercialisation. One clear lesson has emerged from our experience: the companies that thrive in an uncertain regulatory environment are those that build regulatory readiness into their innovation processes from the outset. Regulation is no longer an endpoint to be reached; it must become an active part of innovation strategy.

Navigating the grey areas of emerging technologies

Emerging technologies rarely fit neatly into established regulatory categories. Artificial intelligence tools, for example, can be dynamic by design, continuously learning from new data. This poses significant challenges for traditional regulatory approaches based on static validation at a fixed point in time.

Digital health applications raise questions about whether products are classified as wellness tools or medical devices, with significant implications for development timelines and investment risk.

Combination products, advanced therapies, and novel diagnostics often cross existing regulatory boundaries, requiring companies to navigate multiple frameworks simultaneously. In these grey areas, uncertainty can cause significant delays, increase costs, and erode stakeholder confidence.

Through our work with a broad range of clients, we have seen that the most effective response is to recognise regulatory ambiguity early, and to treat it as a strategic consideration. Organisations that succeed in these sectors invest early in building flexible, risk-based quality systems, generating robust evidence, and creating clear internal decision-making frameworks that can adapt to evolving regulatory expectations.

Good practice: Embedding regulatory strategy early

One of the most important lessons we have learned is the value of integrating regulatory thinking into product design and development from the earliest stages. This approach includes:

• Engaging informally with regulators to test assumptions
• Using modular and iterative development strategies to allow flexibility in addressing evolving evidence requirements
• Building internal cross-functional teams where regulatory, clinical, technical, and commercial perspectives are aligned
• Structuring innovation projects around applicable regulatory lifecycle principles

In practice, this approach helps to de-risk projects, accelerate time to market, and build credibility with investors and strategic partners. It also fosters a culture of innovation that is grounded in patient safety and performance excellence, which strengthens the long-term value proposition of emerging technologies.

Future directions: How regulatory engagement must evolve

Regulators are increasingly recognising that emerging technologies require a new approach to oversight. Initiatives such as the MHRA Innovative Devices Access Pathway and the FDA’s Digital Health Center of Excellence signal a willingness to engage more flexibly and iteratively with innovators.

To build on this progress, there are specific opportunities for frameworks to evolve further. For example, expanding the use of conditional approvals to cover ongoing updates to artificial intelligence algorithms after market launch would better reflect the reality of digital product lifecycles. Similarly, creating regulatory sandboxes for small firms developing combination products would enable safe experimentation and early feedback without imposing prohibitive barriers.

Greater availability of these adaptive models, particularly for small and medium-sized enterprises, is critical. Early dialogue should become the norm, not the exception. Frameworks must support the generation of real-world evidence and conditional approvals where appropriate, while maintaining a clear focus on patient safety and effectiveness.

Industry also has a role to play. Innovators must be proactive in bringing forward evidence-based proposals, collaborating across sectors, and helping to shape the evolution of new standards. Regulatory strategy must be seen as a tool for enabling responsible innovation, rather than a barrier to progress.

An invitation to collaborate

The Midlands is home to a vibrant and forward-looking life sciences community. As Medilink Midlands members, we have an opportunity to lead by example.

Together, we can shape the next generation of regulatory frameworks, making the Midlands a model for how innovation and oversight move forward hand in hand. I encourage fellow members to share experiences of navigating regulatory grey areas, examples of good practice, and ideas for strengthening early engagement with regulators.

By combining our expertise, insights, and ambition, we can help to ensure that transformative technologies reach patients quickly, safely, and sustainably.

I look forward to hearing your perspectives and working together to drive positive change.

In partnership with Sequel Consultants