Authors Patrick Trotter & Stefanie Read from Medilink UK
Innovation and product development in the MedTech and life sciences industry is high risk, with many products failing in the marketplace. Therefore, in order to de-risk and accelerate product development it is important to have strategies and processes in place that ensure the innovation is addressing real market needs and these needs are translated into product design. In addition, it is important to ensure that the product is aligned with health economic drivers to secure adoption and that the quality and regulatory documentation is completed in a timely manner.
Why Innovation is Important for MedTech
Innovation and new product development is key to the survival of companies, to maintain or improve their position and as an important driver growth. Increasing global competition, enhanced regulations, and stakeholder expectations mean that an innovation strategy is critical to company survival. The future portfolio also needs to be balanced across incremental, substantial and radical innovations to provide the opportunity for optimal growth, while minimising commercial risks. Furthermore, the company’s ability to execute successful product launches, accompanied by the right evidence is critical to its success.
MediPath Innovation RoadmapTM
The Medilink team have developed the MediPath Innovation RoadMapTM which is a comprehensive end-to-end pathway for the medtech industry, broken down into six stages, from problem identification/idea conception through to market launch and beyond. This roadmap integrates all the commercial considerations alongside the key technical, clinical, quality and regulatory requirements.
Recognising the industry need for understanding the steps, timelines and costs involved in bringing a medical device to market, we have mapped out this process into six comprehensive stages. Successful product development is not just about designing and launching a product. There are many more steps involved to ensure that the market opportunity is sufficiently attractive, the device will gain regulatory approval, and reimbursement will be achieved. All these stages are critical for successful product commercialisation.
The MediPath Innovation RoadMap is briefly comprised of – Stage 1: Innovation Strategy, Stage 2: Opportunity Analysis, Stage 3: Product Development – Early Stage, Stage 4: Product Evaluation, Stage 5: Product Development – Clinical, Stage 6: Regulatory & Quality Compliance.
Medilink can assist with activities at any stage, but from a general perspective, we can work with you to understand activities and costings as part of an R&D plan, whether the project will be internally funded or covered in part by public grant funding.
MediPath can be used to identify gaps and to optimise your R&D plan, which will help determine the costs and timelines to get the product to market.
Further details can be found at https://medilink.co.uk/services/medipath-innovation-roadmap/
Other key services
The Medilink Innovation, Commercialisation and Regulatory team provide bespoke support at any point in the MediPath Innovation Roadmap. Examples of our key services include
- Market and competitor analysis including the use of our proprietary Medilink Innovation Matrix methodology and presentation tools to succinctly summarise the competitor landscape with opportunities and threats.
- Value proposition to ensure the technology is aligned to clinical and health economic drivers and the creation of an evidence generation plan to reduce commercial risk.
- Regulatory strategy and planning, including our gap analysis and troubleshooting services, training, alignment of product labelling using both commercial and regulatory considerations, technical file documentation (including our specialism in Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER). Our CER service encompasses everything from Class I self-registered software devices to class III implantable and everything in between.
Medilink UK can provide bespoke support at any stage of your product development journey, whether you are a start-up at the beginning of your journey, an experienced global medical device manufacturer, to an academic or clinician wanting to commercialise an idea.
Case Studies
Case Study 1 – Huntleigh Healthcare Ltd – LifePulse 110 R Wave Synchronisation Monitor
The Medilink Innovation and Commercialisation team supported Huntleigh Healthcare Ltd with a detailed Clinical Evaluation Report for their LifePulse 110 R Wave Synchronisation Monitor. A novel device with clear patient safety benefits that today 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 and has 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.
LifePulse 110 R Wave Synchronisation Monitor
Case Study 2: ClotProtect Therapeutics Limited – Market and Competitor Assessment
Medilink conducted a thorough market and competitor assessment regarding the opportunities for ClotProtect’s small molecule to attenuate blood loss. The work was conducted with considerable insight including identifying types of clinical need, which could represent commercial opportunities. The assessment also analysed existing types of solution with their benefits and limitations including clinical risks. The report included a list of top-level design requirements, and an appraisal of how the technology might be differentiated from existing solutions. The work was important for the strategic direction in the formation of the University Spin out – ClotProtect Therapeutics Limited.
Prof. Helen Philippou, CEO, Co-Founder, Biology Lead, ClotProtect Therapeutics Limited.
Innovation, Commercialisation and Regulatory expertise is one of a number of services provided by Medilink UK.
The expert and experienced Medilink UK team provide specialist services aimed at manufacturers of medical devices, diagnostics, drug delivery systems (OEM and supply chain), digital health companies, service and research institutions, NHS organisations, universities, and combined authorities/development agencies.
The other specialist services include:
INTERNATIONAL CONSULTANCY
Medilink’s international trade and sector specialists work with companies around the UK to identify opportunities in new international markets, creating bespoke market entry strategies including regulatory regime and reimbursement routes, for companies of all sizes.
EVENT & CONFERENCE MANAGEMENT
Lose the stress of event management and have Medilink provide services from email campaigns through to fully managed events.
DESIGN & MARKETING
Medilink UK has extensive design experience in the medtech and life sciences sector. For over 30 years, the organisation has supported manufacturers, research centres, and NHS organisations with tailored design, branding, and publishing services.
Additionally, Medilink UK provide a number of activities to support the UK life sciences community, including International Exhibitions and Support, Medilink UK National Awards, and various Sponsorship Opportunities.
Medilink UK is a unique UK life sciences network and specialist service provider. www.medilinkuk.com
