The medtech industry in 2025 stands at the cutting edge of innovation, driving remarkable advancements in diagnostics, remote care, AI-assisted surgery and wearable health technologies. Yet, despite its undeniable progress, the sector faces a number of significant challenges that threaten to slow its momentum.
From complex regulatory landscapes and escalating cybersecurity threats to rising R&D costs and the ever-present pressure to demonstrate real-world impact, medtech companies are navigating a minefield of issues. That is, supply chain disruptions, talent shortages and data privacy concerns are further complicating matters, especially for startups trying to scale.
As healthcare becomes more digital, connected and globalised, the stakes have never been higher. We’ve chatted to experts in the industry in order to explore the most pressing hurdles confronting the medtech world in 2025, and what they mean for innovation, patient outcomes and industry growth in the years to come.
Navigating Regulation and Innovation: A Delicate Balancing Act
One of the most pressing issues for medtech companies in 2025 is the challenge of balancing rapid innovation with stringent regulatory compliance. As technologies evolve – particularly those involving AI, machine learning and personalised medicine – existing regulatory frameworks often struggle to keep up.
For startups and smaller firms, navigating these complex, sometimes ambiguous, requirements can be both time-consuming and costly. Delays in approvals can stall product launches and discourage investment, while differing international standards add further layers of difficulty for companies aiming to scale globally.
At the same time, regulators face pressure to safeguard public safety without stifling innovation. This ongoing tension requires clearer guidance, stronger collaboration between regulators and innovators and more adaptive frameworks that can evolve alongside the technology itself. For medtech to thrive, regulation must become an enabler of innovation – not just a gatekeeper.
So, what do the experts have to say? Let’s find out.
Our Experts:
- Lucy Hope: Founder of The Daughters of Mars
- Fiona Garin: VP Strategic Marketing and Innovation EMEA, BD (Becton Dickinson)
- Laura Bowler: Senior Manager, Sustainability Consulting at Ramboll
- Andrew Archibald: CEO of Medmin
- Dr. Stuart Grant: Founder and Principal Consultant of Archetype
- Mel Hall: Legal Director at Morton Fraser MacRoberts (MFMac)
- Timo Lehne: CEO of SThree
- Ian Burgess: Managing Director at Canary Care
- Collin Neale: Principal Cellular & LEO IoT Connectivity Specialist at Wireless Logic
- Joao Pereira: Director, EMEA, General Embedded Markets at QNX
- Tamaisha Eytle: Director of FutureBARBADOS
- Jeremy Gurewitz: Co-Founder of Solace Health
Lucy Hope, Founder of The Daughters of Mars
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“Medtech can’t claim to be innovative while women’s health remains decades behind. Conditions like endometriosis, chronic UTIs and vaginal infections affect millions yet funding, research and clinical innovation are shockingly scarce. Why? Because women’s health has been systematically deprioritised, dismissed as ‘too complex’, ‘too hormonal’, or not commercially appealing.
This isn’t a scientific issue – it’s a structural and political one. Startups working in this space face investor bias, outdated regulations and a lack of access to gender-specific data. We need public funding and regulatory reform explicitly focused on closing the gender health gap. If policymakers are serious about innovation, they must stop treating women’s health as a side project. The future of medtech depends on it.”
Fiona Garin, VP Strategic Marketing and Innovation EMEA, BD (Becton Dickinson)
The NHS Long Term Plan calls for smarter, faster, more sustainable care. To deliver it, we must embed medtech at the heart of healthcare delivery, not as pilots or one-off purchases, but as a strategic enabler of system-wide transformation.
At BD, we believe the focus must be on what’s necessary: tackling inefficiencies, supporting overstretched workforces, and driving safer, more connected care. For example, pharmacists spend over half their time on non-clinical tasks – imagine the impact of returning that time to patient care.
But medtech cannot act alone. We need cross-sector collaboration, modernised procurement, and longer-term thinking. Resilient healthcare demands that we stop treating innovation as optional—and start embracing it as essential.
Medtech innovation is no longer optional but foundational to sustainable care
“Across EMEA, healthcare systems are under sustained pressure. Ageing populations, increased chronic diseases, backlog of procedures/waiting lists, staff shortages, burnout and productivity, cybersecurity threats, rising costs are straining access to high quality care and resilience. In this context, medtech must no longer be viewed as a ‘nice-to-have’—it is essential infrastructure.
The NHS 10 year plan envisions smarter, faster, and more sustainable care. But to realise this vision, we must embed medtech at the heart of healthcare delivery. This means moving beyond episodic and transactional procurement and pilot projects, and instead recognising medtech as a strategic enabler of system-wide transformation.
At BD, we believe the industry must focus on what’s necessary:
- Tackling inefficiencies that waste time and resources
- Supporting the workforce, especially as burnout and shortages rise
- Ensuring patient safety, making care more connected, and data-driven
Consider pharmacists. Studies show that more than half their time is spent on non-clinical tasks. Imagine the impact of returning that time to patient care, across thousands of professionals, every day.
But medtech cannot solve these challenges alone. It requires collaboration across the ecosystem, from policymakers and payers to clinicians and innovators. We must align incentives, modernise procurement frameworks, and take a longer-term view of value. For example, many sustainability initiatives struggle to gain traction because financial planning cycles rarely extend beyond twelve months, making it difficult to realise long-term benefits.
Some hospitals are already leading the way, embedding medtech into their operational and clinical strategies. These examples show what’s possible when innovation is matched with courage, commitment and collaboration.
To build the resilient healthcare systems our populations need, we must stop treating relevant medtech innovation as an add-on, and start embracing it as essential.”
Laura Bowler, Senior Manager, Sustainability Consulting at Ramboll
“Sustainability will be one of the biggest challenges in the medtech industry in the coming years. Despite recent shifts in regulations and political administrations, overall global pressure to reduce carbon emissions and waste continues to grow. Medtech companies face the unique challenge of trying to balance environmental responsibility with the need for sterility, safety, and innovation.
The industry relies heavily on single-use plastics, energy-intensive manufacturing, and complex global supply chains, all of which can make decarbonization and circularity particularly difficult. At the same time, increasing regulatory scrutiny, investor expectations, and healthcare system demands for sustainable products are pushing the industry to evolve.”
Andrew Archibald, CEO of Medmin
“The biggest challenge for MedTech? Proving it works.
Healthcare is a high-stakes, high-scrutiny environment. It’s not enough to create tech that looks shiny or feels innovative – you need to show, unequivocally, that it makes a meaningful difference to patient outcomes.
The standard for MedTech is the same as for pharmaceuticals: rigorous clinical validation. That means controlled trials, long-term data, and a weight of evidence – not just clever marketing or sleek design. Medicine has a high bar for proof and a low tolerance for risk, for good reason. Every new technology must be more than just safe and effective in the short term; it needs to improve health outcomes significantly and sustainably.
As health systems face rising costs and increasing scrutiny, “nice to have” is not good enough. The future of MedTech belongs to those who can stand up and say: Here’s the evidence. This makes people better.”
Dr. Stuart Grant, Founder and Principal Consultant of Archetype
“MedTech R&D faces pressure from multiple sides. Talent shortages are delaying innovation – especially the need for hybrid experts who can bridge the gap between clinical science and AI, software, and user experience.
Without these experts, cross-functional development slows down. At the same time, the costs and time needed to bring a device to market remain high. Long development cycles, clinical trials, and uncertain reimbursement make investors hesitant, which slows early-stage innovation. With more devices connected to networks, cybersecurity becomes critical. R&D cannot overlook the importance of secure-by-design systems, especially when handling sensitive health data. Every weak spot can lead to a regulatory, legal, or reputational crisis.
Adding to the challenge is the increasing demand for real-world evidence. Regulators and payers now expect proof that devices work not only in trials but also in everyday clinical settings. This requires building data collection, monitoring, and analytics into the process from the outset, adding extra work for R&D teams and further extending the development timeline, which necessitates additional funding.”
Dr. Stuart Grant is one of our expert judges participating in this year’s MedTech38 competition.
Mel Hall, Legal Director at Morton Fraser MacRoberts (MFMac)
“One of the biggest legal challenges facing the medtech industry is the lack of international regulatory alignment – particularly with the UK now taking acting steps to diverge from the EU approach. Most medtech companies want to commercialise their products globally, but each jurisdiction comes with its own regulatory framework. In practice, that means navigating complex, and sometimes divergent, requirements to access key markets.
This issue becomes even more pronounced when companies develop AI-driven medical technologies. While innovation in this space is accelerating, regulatory certainty is lagging. The EU AI Act and the UK’s pro-innovation AI framework differ – making it complex for companies to scale confidently across borders.
To overcome this, medtech firms need tailored legal strategies that factor in cross-jurisdictional compliance, data governance, and long-term product lifecycle planning. Without this, they risk costly delays in bringing life-changing technologies to patients.”
Timo Lehne, CEO of SThree
“Medtech is one of the fastest-moving innovation sectors but sustaining that momentum depends on a reliable pipeline of specialist STEM talent, and right now, that’s one of the industry’s biggest vulnerabilities.
From biomedical engineers to data scientists, demand is rising fast, yet the talent pipeline isn’t keeping pace. While academic foundations are strong, we’re not converting knowledge into capability at scale. Too often, skilled graduates lack clear pathways into industry, and businesses are hiring for roles that didn’t exist five years ago.
But the challenge goes deeper. Regulatory complexity, post-Brexit uncertainty, and tightening investment conditions are all putting pressure on growth. At the same time, internal talent, the engine of long-term innovation, is being stretched thin.
If we want medtech to thrive, we need urgent action on workforce strategy: better coordination between academia and employers, smarter investment in emerging skills, and stronger incentives to attract and retain specialist talent. The future of medtech depends on it.”
Ian Burgess, Managing Director at Canary Care
“The MedTech industry faces a number of challenges in the coming years. Although the government has committed to integrating technology into the health and care sectors, innovation and digital transformation must be matched by real, practical action. Currently, too many local authorities and NHS teams are still struggling to access and implement the technology that makes a difference.
Additionally, the security of an individual’s data will pose a huge challenge to the MedTech industry. Ensuring that confidential data remains secure should be paramount for medical technology providers to ensure patient safety, and to maintain patient trust.
Finally, medical technology must remain easy to use, to avoid implications of technology skills gaps for users, families and healthcare workers. To ensure medical technology is seamlessly integrated into existing systems, a combination of intuitive technology and sufficient training must be available.”
If you would like further details or wish to arrange an interview, please let me know. Ian is also happy to provide additional commentary on the challenges and downfalls of Tech Enabled Care adoption in social care, or to discuss a potential byline on this topic if you are interested.
Joao Pereira, Director, EMEA, General Embedded Markets at QNX
“The NHS’s ambition to significantly expand robot-assisted surgeries offers a clear path to tackling persistently long waiting lists, driven by the proven efficiency and accuracy these technologies provide. Recent QNX research reveals a strong appetite for the rollout of robotics within healthcare and wider industry, with almost two-thirds (64%) of UK organisations keen to adopt them.
Despite positivity for the role robotics can play, a concerning gap exists between this ambition and tangible action as only 12% of UK technology industry leaders have concrete plans to implement robotics in the next year, and nearly a third (29%) remain undecided. This hesitation is rooted in uncertainty and safety concerns, with 43% of leaders in healthcare organisations listing ‘safety’ as a significant factor influencing their trust in robotics.
The NHS must prioritise trusted, high-performance, real-time solutions that adhere to rigorous safety standards and offer comprehensive, foundational security features. Choosing the right technology will allow us to revolutionize the field of robot-assisted surgeries, setting new standards for the future of healthcare, ensuring that robotics truly deliver on ambitions to improve patient outcomes and reduce waiting times.”
Tamaisha Eytle, Director of FutureBARBADOS
Solving this isn’t just about introducing new tools. It requires a citizen-centred, multisectoral shift—and the intentional building of an innovation ecosystem that supports creation, not just consumption.
FutureHEALTH is designed to drive that transformation. By connecting policy reform, knowledge exchange, and innovation support across public, private, academic, and diaspora networks, it aims to unlock real-world solutions that improve care, reduce costs, and build long-term system resilience.”
Jeremy Gurewitz, Co-Founder of Solace Health
“In my role as the founder of an organization that works to improve healthcare in the U.S. and give everyone a voice in their healthcare, the medical technology industry faces significant challenges that may influence its future. Regulatory hurdles, such as the F.D.A.’s changing oversight of AI, could require expensive compliance, slowing innovations like A.I.-powered diagnostics, which may be able to catch diseases earlier. For example, the FDA’s 2024 guidance on predetermined change control plans for AI, which aims to balance between innovation and safety, but slows market entry for startups. Cybersecurity is equally urgent; ransomware incidents against healthcare grew 40% from 2020 to 2023, endangering patient information and device operation (like in the 2023 IBM insulin pump flaw).
Supply chain instability, driven by 50% tariffs on steel and aluminum, means the cost of devices like stents is driven up, while reimbursement issues limit patient access to cutting-edge devices. My organization pushes for transparent pricing and diversified sourcing to stabilize costs. Only by breaking down these barriers can we be confident we are providing a level playing field for medtech to bring life-saving innovations to patients – and this is, of course, our mission.”
