Innovation & Commercialisation
Medilink’s Innovation & Commercialisation team provide specialist resource with considerable practical expertise to private and public sector organisations in the Life Science sector
What we do
Our highly experienced innovation, commercialisation and regulatory team can help you unlock your innovation capabilities, understand the regulatory environment and ensure your products are compliant.
Why choose us
At Medilink we can help you de-risk and maximise the probability of success for your Innovation, new product or service, supporting you in understanding markets and identifying opportunities.
Find out more
Wherever you are in your journey and whatever size of organisation, please call our innovation specialists on 0114 232 9292 or email innovation@medilink.co.uk
Our Services
Our consultancy service is comprehensive and often bespoke and includes:
Innovation strategy, portfolio and planning
We can help you develop your innovation/ product development strategy and support you in understanding markets, how to identify opportunities and how to convert these into product development opportunities. This can be in the form of training, in house workshops or specific projects.
Market, competitor, technology analysis and reports
Market, competitor and Technology reports are frequently commissioned to understand the landscape and are designed and scoped to understand the specific needs of the client. Typically, they either have a market or technology emphasis (or a mixture of both) and provide information on competitor solutions (e.g., technology segmentation, product positioning and claims) (either in market, near to market or early stage), and can be scoped to include information on market size and segmentation, patient pathways and clinical guidelines and can include an overview of regulatory and reimbursement considerations.
Companies use market/ competitor and technology analysis to make Go/No decisions with regard to investment decisions, use such reports as a means to identify new technologies or companies to acquire via licensing or acquisition activities or commercial partnerships or simply use the analysis to improve product design and to ensure product differentiation.
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 and often results 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 d developing evidence generation plans (which can be included as part of the value proposition) that feed into clinical trial design to ensure the right evidence if collected to support adoption and market penetration.
MediPath innovation roadmap
Medilink have developed the MediPathTM Innovation Roadmap to help our clients plan their innovation journey to reduce risk, accelerate the speed to market, maximise the probability of market success and enhance profitability.
Drawing on our extensive experience and understanding of best practice, our team of experts have created a new tool to ensure that all key activities and milestones are considered. MediPathTM 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.
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.
Gap analysis
Since the publication of the MDR (EU 2017/745) and IVDR (EU 2017 / 746) we have developed a gap analysis service that uses a bespoke tool to audit compliance of your Technical File with the MDR. This includes three levels of service in which we provide a bronze level of support covering each element of your technical file during interactive sessions with verbal advice and feedback, through to our full gold service in which we provide an in-depth analysis of the technical documentation and a detailed report identifying gaps and recommendations with regard to how they can be addressed.
Technical file documentation
We can provide guidance, additional resource, or advice on your 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.
Regulatory training and workshops
Our training solutions range from introductory training covering the regulatory process (with a focus on UKCA and EU MDR), and types of technical documentation to more detailed courses and workshops covering the design history file, design control and technical file construction (including product labelling, information to be supplied by the manufacturer, design and manufacturing information), the General Safety and Performance Requirements (GSPRs), benefit risk analysis, risk management, clinical evaluation and post market surveillance requirements.
Our courses and workshops are tailored to your individual need and are designed to be interactive in which you benefit from bespoke consultancy during the sessions.
Clinical evaluations report (CER) / Performance evaluation reports (PER)
A Clinical Evaluation Report (CER) is a key component of the technical file and is used to support the intended purpose, product claims and to demonstrates that the benefits outweigh the risks.
The CER/ PER is a pivotal part of the technical documentation which is needed to both get a CE mark and also to maintain the product on the market.
The Medilink Team have extensive experience in authoring CERs.
Recent guidelines MDCG 2020-6 provide alternative means to for you to show conformity to the relevant General Safety and Performance Requirements (GSPRs) for legacy devices and might offer an alternative CER strategy to the conventional one described under MDR.