Innovation
on market size and segmentation, patient pathways and clinical guidelines. It can also include an overview of regulatory and reimbursement considerations.
l Value proposition One of the key reasons why medical products fail in the marketplace is that the value proposition has not been developed early enough to influence further development work, often resulting in non-optimal claims being defined and poor clinical trial design that does not gather the right evidence to improve the probability of adoption. Medilink provides an early-stage value
proposition service to align the product or service to quality indicators that govern flows of money and, as such, are highly useful in developing evidence generation plans (which can be included as part of the value proposition) that feed into clinical trial design. This ensures the right evidence is collected to support adoption and market penetration.
l Regulation The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), coupled with Brexit (UKCA marking), have seen companies in the sector struggle to understand the changes and also to resource and ensure that their technical documentation complies. The risk is that devices will be delayed getting to market, or if already on the market, companies might lose their certification. Medilink provides advice
Medilink have developed the MediPath Innovation Roadmap to help companies and organisations plan their innovation journey to reduce risk, accelerate the speed to market, maximise the probability of market success and enhance profitability.
across the regulatory field, as well as training and workshops.
l Gap analysis Medilink has developed a gap analysis service that uses a bespoke tool to audit compliance of Technical Files with the MDR – a detailed report identifying gaps and recommendations with regard to how they can be addressed.
l Technical file documentation Medilink can provide guidance, additional resource, or advice on documentation – from the design history file that documents all the design and development activities, to the technical documentation, according to MDR 2017/745/ IVDR 2017/746.
l Clinical and performance evaluation reports Medilink undertakes strategy workshops which can help determine whether devices qualify as a legacy device and to determine
potential equivalence and similar products you can use. This also covers the area of selection of products for benchmarking performance and safety and concludes with a full writing service if this is required.
l MediPath Innovation Roadmap Medilink has developed the MediPath Innovation Roadmap to help companies and organisations plan their innovation journey to reduce risk, accelerate the speed to market, maximise the probability of market success and enhance profitability. Drawing on extensive experience and understanding of best practice, the team of experts have ensured that all key activities and milestones are considered. The roadmap gives a comprehensive breakdown of all commercial, technical, clinical, and regulatory actions, along with the associated resources, costs, and time to get a medical device to market. For more information
https://medilink.co.uk/ services/medipath-innovation-roadmap/
Case study: Wave synchronisation monitor The Medilink Innovation and Commercialisation team supported Huntleigh Healthcare with a detailed Clinical Evaluation Report for their LifePulse 110 R Wave Synchronisation Monitor. This is a novel device with clear patient safety benefits that can be found in hospitals throughout the country and overseas. The monitor allows CT scans to be taken of the heart in a non-invasive way. The advantage of cardiac triggering or ECG gating is that it instructs the CT scanner to take a scan during the R-R interval during a single beat of the heart and, in doing so, reduces the exposure of the patient to radiation compared to non- triggering/ ECG gating protocols.
The geko device is clinically proven to increase blood flow. 46
www.clinicalservicesjournal.com I February 2026
Case study - geko device with OnPulse technology The Medilink Innovation and Commercialisation team also supported Sky Medical Technology with an ethnography study, in which they went into the Stroke Unit at Stoke Mandeville
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