Groundbreaking innovations within MedTech and navigating the Market Access landscape in the UK
Decisive Consulting Ltd
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As we step into 2024, the United Kingdom's Medical Technology (MedTech) landscape continues to evolve at an unprecedented pace, driven by technological advancements and a growing emphasis on healthcare solutions that leverage the power of data and artificial intelligence. In the dynamic world of MedTech, gaining market access is a pivotal step in bringing innovative solutions to patients and healthcare providers. This article explores exciting areas of development as well as the challenges, opportunities, and strategies involved in navigating the complex landscape of market access for MedTech in the UK.
The rise of MedTech
In 2020, the global MedTech market was valued at around $500 billion and is projected to grow from $536 billion in 2023 to almost $800 billion by 2030. 1 Factors contributing to this significant growth include the rapid technological advancements in medical devices, increased investment and funding in the sector, an ageing population worldwide and the rising prevalence of chronic diseases such as diabetes, cardiovascular disorders and respiratory illnesses. A number of areas are attracting a lot of attention in MedTech and are seeing a high number of technologies being adopted by healthcare providers.
Digital health platforms
The adoption of digital health platforms has gained momentum, fostering enhanced communication between healthcare professionals and patients. These platforms offer secure channels for telemedicine, virtual consultations and remote patient monitoring. Improved interoperability between healthcare systems has further streamlined information exchange, resulting in more coordinated and patient-centric care. As a result, patients have greater access to medical advice than previously, and healthcare providers can deliver services efficiently. The use of digital health platforms may be especially beneficial for patients in rural or under-resourced areas, helping to reduce the inequalities that exist in healthcare.
Wearable health tech
The integration of wearable devices equipped with biosensors and sophisticated monitoring capabilities has enabled continuous health tracking and remote patient monitoring. This trend has not only empowered individuals to take charge of their own health but has also facilitated proactive healthcare interventions. From smartwatches monitoring vital signs to implantable devices transmitting real-time data, wearables are reshaping the feedback pathway from patients to doctors and paving the way for personalised medicine.
Artificial Intelligence and machine learning
Artificial Intelligence (AI) and machine learning (ML) have become indispensable tools in the MedTech toolbox. AI algorithms are now being used for a wide range of applications, including diagnostic support, drug discovery, and treatment optimisation. These technologies analyse vast datasets to identify patterns, predict disease trajectories and recommend personalised treatment plans. For more information on the developments in AI and their impact on market access, see our series of articles which discuss this topic. ?
Diagnostics and imaging
Advanced imaging modalities, such as AI-powered radiography and next-generation medical imaging devices, have become instrumental in early disease detection and personalised treatment planning. These technologies not only enhance diagnostic accuracy but also contribute to efficient and cost-effective healthcare delivery. They also aid standardisation in indications where diagnosis is typically performed visually by clinicians and significant variability exists.
Other interesting areas of innovation
There are a few other notable areas of advancement that are worth mentioning, such as: robot-assisted surgery, nanotechnology, 3D printing of implants and prosthetics and blockchain technology to improve the security and interoperability of healthcare data.
Navigating market access for MedTech in the UK
Any company intending to introduce a new medical technology to the UK market must have an insight into the process for gaining regulatory approval and subsequent adoption into the healthcare system. After completing pre-clinical testing and other trials to evaluate the performance of a new product there are several steps to follow to ensure successful uptake of the technology.
Regulatory compliance
The first priority for any MedTech company entering the UK market is ensuring compliance with regulatory standards. The Medicines and Healthcare products Regulatory Agency (MHRA) plays a crucial role in overseeing the safety and performance of medical devices. MedTech companies must navigate the regulatory landscape to obtain the necessary approvals and certifications, such as the UK Conformity Assessed (UKCA) mark, to demonstrate compliance with medical device regulations. Following the UK’s departure from the European Union (EU), a Conformité Européenne (CE) mark is still needed for devices placed on the Northern Ireland market.
Health Technology Assessment
As with new medicines, in the UK, the National Institute for Health and Care Excellence (NICE) conducts Health Technology Assessments to evaluate the clinical and cost-effectiveness of new technologies via the HealthTech evaluation programme. This programme incorporates the evaluation of medical technologies, diagnostic tools and interventional procedures. Companies must provide robust clinical and economic evidence to support their technology's value proposition. Successful completion of a NICE assessment can significantly impact the adoption of a MedTech product within the National Health Service (NHS). The reimbursement process is intricate, so collaborating with reimbursement experts and understanding the nuances of the reimbursement framework are crucial for negotiation with the NHS and payers.
NHS procurement
The complexity of the NHS, with multiple stakeholders and key decision makers, requires companies to understand and engage with various NHS bodies, including individual hospitals as well as regional and national clinical commissioning groups. Building strong relationships with key decision-makers, understanding local needs, and demonstrating the economic benefits of the technology are essential components for successful market access. Establishing partnerships with distributors, healthcare providers, or research institutions can facilitate a smooth entry into the market. Local partners bring invaluable insights into the healthcare landscape and can provide a platform for technology adoption by showcasing the real-world impact of MedTech innovations.
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Real-world evidence and post-market surveillance
The collection of real-world evidence (RWE) is becoming increasingly important for market access. Demonstrating ongoing safety and effectiveness of a product through post-market surveillance and RWE builds a strong case for its increased adoption. Engaging in post-market studies, monitoring long-term outcomes and adapting products based on real-world feedback are crucial elements in maintaining market access and ensuring sustained success.
Common challenges
Demonstrating the effectiveness of MedTech poses several challenges that companies must navigate to bring their innovations to market. Regulatory bodies often require robust clinical evidence to establish the safety and efficacy of products, but designing clinical studies may be complex, especially when dealing with novel technologies. Therefore, it is important to strike a balance between meeting regulatory requirements and conducting feasible studies. Identifying appropriate clinical endpoints that align with regulatory expectations can also be challenging. Chosen endpoints should be clinically relevant and sensitive to changes induced by the intervention. Some technologies may not directly affect patient outcomes but offer other benefits such as increased speed of healthcare delivery and reduced operational costs, which must be captured using efficiency-related outcomes. The fast-paced nature of technological advancements means that challenges are also posed to regulatory bodies in keeping up with evaluating innovative products. Regulatory frameworks may need constant updates to address new and emerging technologies.
Conclusion
The MedTech landscape in 2024 stands at the intersection of technological prowess and a commitment to improving healthcare outcomes, with the industry experiencing continual transformation as innovations continue to unfold. Successfully navigating the market access landscape for MedTech in the UK requires a multi-faceted approach —from regulatory compliance and HTAs to procurement processes and reimbursement strategies, MedTech companies must be strategic and proactive in their efforts. The collaborative nature of the UK healthcare system and the emphasis on real-world evidence underscores the importance of continued engagement post-market entry. By understanding and addressing these challenges, MedTech innovators can bring their transformative technologies to the forefront of the UK healthcare ecosystem, ultimately benefiting patients and advancing healthcare delivery.
Get in touch with Decisive Consulting Ltd to explore how we can help navigate your journey through Market Access for MedTech products.
Source references:?
1. Fortune Business Insights (2023) Medical Devices Market Size, Share & Covid-19 Impact Analysis, By Type (Orthopaedic Devices, Cardiovascular Devices, Diagnostic Imaging, In-Vitro Diagnostics, Minimally Invasive Surgery, Wound Management, Diabetes Care, Ophthalmic Services, Dental Devices, Nephrology, General Surgert and Others); By End User (Hospitals, ASCs, Clinics and Others) and Regional Forecast 2023-2030.
2. Getachew et al. (2023) Digital health in the era of COVID-19: Reshaping the next generation of healthcare. Frontiers in Public Health
3. Devi et al. (2023) 5G Technology in Healthcare and Wearable Devices: A Review. Sensors, 23(5).
4. Najjar (2023) Redefining Radiology: A Review of Artificial Intelligence Integration in Medical Imaging. Diagnostics 13(17).
5. Medicines and Healthcare Products Regulatory Agency (2020) Medical devices: conformity assessment and the UKCA mark
6. Klein et al. (2022) Real-World Evidence in Health Technology Assessment of High-Risk Medical Devices: Fit for Purpose? Health Economics 31(S1), p 10-24.
Tech Innovation Advisor | Digital Health | Data & Evidence| Patient advocate
10 个月Interesting blog team Decisive Consulting Ltd. thank you for sharing! Also worth highlighting that the market access path varies widely across Europe. The CE/UKCA regulatory stamp of a specific intended use is often the bare minimum. But getting reimbursement/payment follows different approaches. In the UK, although a NICE appraisal is valuable, it does not correlate with being funded via the NHS. Different ICS/ICB may or may not fund a medtech intervention regardless of the NICE appraisal. Finally, #RWE is absolutely key to most medtech. The pre-market device clinical trial is often low or non-interventional. And generally, a PMCF or registry or PMCF survey is needed for most devices on the market.