Tony Cambridge, Independent Consultant-Diagnostics and Innovation
I work with many companies in the Life Sciences sector, and I repeatedly hear the same message- ‘We have the technology and clinical evidence, but it can take years to penetrate the marketplace and achieve routine use in healthcare.’
The development of new diagnostics and medical devices has accelerated considerably, with technologies ranging from point-of-care testing (POCT), novel molecular diagnostics and wearable sensors to artificial intelligence, remote monitoring, advanced imaging and connected medical devices. But adoption is not occurring at the same rate. Translating a promising technology from development into routine patient care remains a challenge that frustrates the life sciences industry and stalls transformation.
The central problem is that regulatory approval, clinical evidence, economic evaluation, funding, procurement and clinical adoption are separate stages, often involving different organisations, decision-makers and evidence requirements.
A fragmented landscape of NHS networks with differing priorities results in a lack of adoption standardisation. A device may therefore be safe, technically effective and commercially available, yet still struggle to become part of everyday clinical practice.
This is particularly important in the NHS, where adoption requires not only evidence that a technology works, but also evidence that it improves a clinical pathway, provides value for money and can be implemented within existing workforce, infrastructure and financial constraints.
1. Regulatory complexity and changing requirements
Regulation is one of the first significant barriers facing manufacturers. Medical devices and in vitro diagnostic devices must satisfy regulatory requirements before they can be legally placed on the market. In Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees medical devices and IVDs under the UK Medical Devices Regulations 2002, with transitional arrangements allowing certain CE-marked devices to continue to be placed on the GB market. (GOV.UK)
The UK regulatory environment has also been evolving following in recent years. Manufacturers potentially must understand UKCA requirements, CE recognition, MHRA registration, UK Approved Bodies and, for some manufacturers, the appointment of a UK Responsible Person.
For manufacturers, particularly smaller companies, this creates additional costs, uncertainty and regulatory expertise requirements. A technology designed for an international market may need to accommodate different regulatory routes and evidence expectations.
The challenge is not simply obtaining market access. Regulatory approval establishes that a product meets defined safety and performance requirements; it does not automatically mean that the NHS will adopt it.
NICE explicitly distinguishes regulatory requirements from the evidence required by healthcare commissioners and evaluators. (Nice)
This distinction is crucial. A diagnostic may demonstrate excellent analytical performance, for example, but that does not necessarily demonstrate that using the test changes clinical management or improves patient outcomes.
The UK is attempting to evolve its regulatory system to support innovation while maintaining patient safety. The MHRA’s current reform programme includes changes to pre-market requirements, international reliance and IVD regulation, while its IVD roadmap identifies regulatory support, regulatory science and research as priorities for 2026–27. (GOV.UK)
2. Generating the clinical evidence required for adoption
A second major obstacle is the generation of convincing clinical evidence.
Developers frequently need to answer several different questions:
- Does the device work technically, is it intuitive?
- Is the diagnostic accurate?
- Is it safe?
- Does it change clinical decision-making?
- Does it improve patient outcomes?
- Does it reduce costs or resource utilisation?
- Can it be successfully integrated into the existing healthcare pathway?
These questions require different types of evidence.
For diagnostic technologies, analytical validity and diagnostic accuracy are important but may not be sufficient. NICE notes that test accuracy alone does not demonstrate clinical utility. Evidence must demonstrate how a test result affects clinical management and ultimately patient outcomes. (NICE)
This creates a particular challenge for innovative diagnostics. A new test may be faster, more sensitive or more convenient than an existing method but establishing the consequences of introducing it into clinical practice can require substantial prospective research.
Clinical investigations can also be expensive and time-consuming. MHRA guidance states that clinical investigations may be necessary to support claims and demonstrate the safety and performance of medical devices. Manufacturers must notify MHRA when applicable and meet specified regulatory requirements. (GOV.UK)
IVDs add another layer of complexity. Diagnostics may be used within clinical trials of medicines, including companion diagnostics, and specific regulatory requirements can apply to these circumstances. (GOV.UK)
The problem of the “evidence gap”
One of the most important barriers is therefore the gap between product development and evidence suitable for healthcare adoption. Health Innovation Networks (HINs) are working hard to support the generation of clinical evidence and accelerate the adoption of proven technology.
A manufacturer may have sufficient evidence to demonstrate regulatory compliance but insufficient evidence for a clinical commissioning decision. Working closely with HINs can help shape the evidence to provide compelling real world use narratives. Conversely, an NHS organisation may be interested in a technology but unwilling to invest in generating evidence for a product that has not yet demonstrated its value.
Schemes exist to support clinical trials, and organisations need improved awareness on sourcing this kind of funding.
This creates a potential cycle:
No evidence → limited adoption → limited opportunity to generate real-world evidence → continued uncertainty → reluctance to invest.
Frameworks such as NICE’s Evidence Standards Framework attempt to address this problem by providing developers and evaluators with clearer expectations about the evidence required. NICE recommends evidence appropriate to the technology’s intended purpose and risk, including comparative studies, real-world evidence and outcomes relevant to patients and healthcare systems. (Nice)
NICE’s Real-World Evidence Framework also recognises the value of routinely collected data for understanding safety, effectiveness, health inequalities, service delivery and the applicability of clinical trial results to NHS patients. (Nice)
3. Funding: who pays for innovation?
Even when a technology has strong clinical evidence, funding can remain a major barrier.
The financial benefits of diagnostics and medical devices do not necessarily occur in the same organisation that pays for them.
For example, a rapid diagnostic introduced in an urgent care setting may have a purchase cost for one service but generate savings elsewhere by:
- reducing hospital admissions;
- shortening emergency department stays;
- avoiding unnecessary imaging;
- reducing laboratory workload;
- enabling earlier treatment;
- reducing follow-up appointments; or
- supporting treatment closer to the patient’s home.
The organisation responsible for purchasing the technology may therefore carry the immediate expenditure while another part of the health system receives some of the financial benefit. Upstream and downstream savings or cost avoidance must be identified and the financial improvements shared appropriately.
NHS England’s London Life Sciences Strategy identifies fragmented financing, annual budgeting and insufficient funding for the “double running” costs associated with implementing innovation as barriers to large-scale adoption. It also highlights slow procurement and limited spread of learning between organisations. (NHS England). A huge barrier to standardisation is the reluctance to share findings across the healthcare landscape, a peculiar trait that has, to this day, been completely lost on me.
If funding is assigned to a project which aims to assess clinical suitability of new innovations there must be caveats in place that assure that the findings are shared widely. Maybe this is a level of scrutiny that prevents engagement, for fear of the work being criticised?
Particularly problematic for diagnostics is that implementation rarely involves purchasing the device alone. Costs can be hidden or not fully understood, including:
- equipment and consumables;
- maintenance;
- software and connectivity;
- middleware;
- information governance;
- IT integration;
- staff training;
- quality management;
- accreditation;
- estates and infrastructure;
- additional staffing; and
- ongoing quality assurance.
NICE’s evidence framework specifically recommends that economic assessment includes the costs of purchasing, maintenance, staffing, training and supporting IT infrastructure, rather than considering the acquisition price alone. (Nice)
Consequently, a technology that appears inexpensive on a unit-cost basis may be considerably more expensive to implement, while a relatively expensive diagnostic may produce substantial system-wide savings.
4. Procurement and commissioning barriers
Regulatory approval and funding do not guarantee procurement.
NHS procurement is necessarily governed by financial, contractual, quality and governance requirements. Organisations also have to consider existing contracts, frameworks, equipment replacement cycles and interoperability.
This can create a difficult environment for innovative companies. Established suppliers may already have contracts covering analysers, consumables, reagents, IT systems or managed services. Introducing a new technology can therefore require changes to several connected components.
NHS England has identified slow and sub-scale procurement as an innovation barrier, noting that suppliers may face different approaches across organisations and that demand is not always aggregated. (NHS England)
For diagnostics, this can result in a pilot culture: an organisation successfully evaluates a technology on a small scale but struggles to move from pilot to routine service.
The technology may be proven, but there is no straightforward mechanism for scaling it across multiple organisations.
5. Resistance or limited appetite for changing clinical pathways
Perhaps the most underestimated barrier is the willingness to change established clinical pathways.
Healthcare systems are designed around existing processes. Introducing a new diagnostic can affect clinicians, nurses, biomedical scientists, clinical engineering, pharmacists, IT departments, procurement teams and patients.
A rapid test, for example, may appear straightforward but could change:
who tests → where testing occurs → who interprets the result → who acts on it → what treatment follows → where the patient is managed.
Consequently, adoption is not simply a technology decision. It is a clinical pathway redesign decision.
Clinicians may reasonably ask whether the new test changes what they would do. If a faster result does not lead to faster treatment, earlier discharge or a different clinical decision, its practical value may be limited.
There may also be concerns about false-positive and false-negative results, additional workload, accountability and the interpretation of unfamiliar biomarkers produced by new analytical methods.
This explains why innovation can fail even when the technology itself is excellent.
Changing pathways requires clinical leadership!
Successful adoption therefore requires clinical champions and multidisciplinary engagement from the beginning.
Rather than asking: “Can we introduce this device?”
Healthcare organisations should ask: “What problem in the patient pathway are we trying to solve, and how will this technology change the pathway?”
The shift from technology-led adoption to problem-led adoption is fundamental.
6. Workforce and infrastructure constraints
Another barrier is implementation capacity.
A new medical device requires competent users, training, competency assessment, quality assurance and ongoing governance. In POCT, for example, responsibility may extend across multiple professional groups and locations.
The technology may therefore increase rather than reduce workload during the implementation phase.
Digital and connected diagnostics introduce additional requirements around interoperability, cybersecurity, data protection and information governance. NICE identifies standards including data protection, information governance and interoperability as relevant considerations for technologies used within healthcare. (Nice)
Infrastructure can therefore become a hidden barrier.
A diagnostic device may be technically capable of producing a result in minutes, but if the result cannot be incorporated into the electronic patient record or communicated to the clinician, much of its potential benefit can be lost.
7. The need for a different adoption model
The barriers described above suggest that diagnostics and medical devices should not be viewed as isolated products.
Successful adoption requires an ecosystem involving:
Regulation → evidence → clinical utility → health economics → funding → procurement → pathway redesign → implementation → real-world evaluation → scale-up.
Failure at any point can prevent adoption.
A more effective approach would involve manufacturers, clinicians, laboratory professionals, patients, researchers, commissioners and procurement specialists much earlier in product development. As an advisor I can certainly recommend early involvement from independent consultants across the diagnostics sector.
Evidence generation plans should also be established before commercial launch. NICE’s framework supports this approach by allowing developers to understand evidence expectations at early stages of product development and to plan evidence generation for later commissioning decisions. (Nice)
The NHS could also make greater use of real-world evidence generated during controlled implementation. Rather than requiring every innovation to arrive with every possible piece of evidence before use, carefully governed evidence-generation programmes could allow promising technologies to be evaluated in real clinical environments while monitoring outcomes, safety and cost.
Conclusion
The obstacles to adopting diagnostics and medical devices are rarely caused by one issue. They arise from the interaction between regulation, evidence generation, funding, procurement, workforce capacity and clinical behaviour.
Regulation is essential for patient safety, but market access is only the first step. Clinical evidence must demonstrate not only analytical or technical performance but also clinical utility and, increasingly, system value. Funding models can make adoption difficult when costs and benefits fall in different parts of the healthcare system. Procurement processes can slow the transition from successful pilot to widespread implementation. Most importantly, established clinical pathways can be difficult to change unless the technology clearly solves a recognised clinical problem.
The opportunity is to move towards a more integrated adoption model in which evidence generation, regulatory planning, economic evaluation and pathway redesign happen concurrently rather than sequentially.
For diagnostics in particular, the future is unlikely to be determined simply by whether a test is faster, cheaper or more accurate. The decisive question will increasingly be whether it can demonstrate a measurable improvement in the way patients move through healthcare systems.
The most successful innovations will therefore be those that combine strong evidence, regulatory readiness, sustainable funding, practical implementation and genuine clinical pathway improvement.
References
- Medicines and Healthcare products Regulatory Agency (MHRA). Regulating medical devices in the UK. GOV.UK. (GOV.UK)
- MHRA. Timelines for acceptance of CE marked medical devices in Great Britain. GOV.UK, 2026. (GOV.UK)
- MHRA. Medical devices that need a clinical investigation. GOV.UK, updated 2026. (GOV.UK)
- MHRA. Clinical investigations in Great Britain. GOV.UK, updated 2026. (GOV.UK)
- MHRA. Clinical investigations for medical devices. GOV.UK, updated 2026. (GOV.UK)
- MHRA. In Vitro Diagnostic roadmap. GOV.UK, 2025. (GOV.UK)
- MHRA. Implementation of the future regulations. GOV.UK, updated 2026. (GOV.UK)
- NICE. Evidence standards framework for digital health technologies. NICE guideline ECD7. (Nice)
- NICE. Real-world evidence framework. NICE. (Nice)
- NHS England. London Life Sciences Strategy – Our challenges. NHS England. (NHS England)
- MHRA. Clinical trials that include an in vitro diagnostic device. GOV.UK, updated 2026. (GOV.UK)