An end-to-end approach across the MedTech Roadmap

Rather than limiting our consulting to just one area, we take a holistic approach. Through our own in-depth expertise and that of a few long-standing key partners, we guide our clients through as much of the medtech journey as they require. 

We seek to understand the intricacies of your business and technology inside out - both now and in the future – enabling a long-term partnership that adds maximum value to your business and provides the best chance of market success for your technology. 

Product validation & market assessment
Establishing the true clinical need is a vital first step. A survey of failed startups determined that 42 per cent of them identified the ‘lack of a market need for their product’ as the single biggest reason for their failure. We help medical device companies validate their product idea to take the risk (that first risk) out of proceeding further.

To enable our clients to understand the complexities of the European market and position them for successful market entry, we conduct a number of assessments and benchmarking exercises including:

  • Competitive landscape analysis
  • Standard of Care Technology Benchmarking
  • Reimbursement Landscape assessment
  • Quantitative and Qualitative surveys and primary market research
  • Sales Channel analysis
  • Recommendations and go-to-market strategies
  • Target user assessment

 

Regulatory affairs
Regulatory approval in Europe this involves building a CE-mark application dossier and appointing a Notified Body to assess your device and an Authorised Representative to overlook this process if your company is based outside the EU. We can help you understand CE requirements and support the process for obtaining European market clearance, including:

  • Confirmation of product classification and CE requirements
  • Development of an implementation plan
  • Supporting requirements for implementation (clinical study/clinical evaluation report)
  • Assisting with development of a technical file
  • Country registrations 

 

Clinical trial management 
From clinical strategy to clinical study management, we can guide you through the complex clinical study process, including: 

  • Clinical creation of bespoke, effective strategies
  • Recruitment of the optimal sites to support study success
  • Resource and expertise that supports the process from start to finish
  • Study initiation, monitoring, reporting and close-out 
  • Stringent data review and analysis
  • Preparation of clinical study reports
  • Creation of strong evidence-based product messaging based on clinical study findings

 

Health economics & reimbursement

The reimbursement compliance procedure varies for each European country – so there is no blanket approach to negotiating the pricing of your device with different health authorities. We can help you understand the particular landscape and prepare for seeking reimbursement. From health economics analysis, to reimbursement roadmap planning, to KOL and society recruitment and regional grants applications, we’ll be by your side.  

  • Health economics analysis: evaluating the current clinical data and benchmarking against existing device(s) to determine what evidence will be required to support the reimbursement dossier
  • Reimbursement roadmap: developing a reimbursement roadmap for the desired countries which clearly sets out the steps to be taken to potentially achieve reimbursement for the product
  • KOL and/or society recruitment: establishing support for product usage and reimbursement, as well as involvement in clinical studies if required, to support reimbursement
  • Regional grants: determining if there are regional grants for new technology and supporting the application process

 

Commercial & go-to-market strategy

Commercial strategy is a complex beast and requires deep market understanding and subject matter expertise. From seeding trials, initial market feedback right through to commercial expansion, setting up the right distribution model and setting up efficient supply-chain solutions, we can bring the right experience and approach:

Establishing the go-to market strategy:

  • Current reimbursement details in EU countries
  • Sales channels involved times the number of markets planned for commercialisation
  • Competitor analysis
  • Analysis of best markets, channels, strategy
  • Identification of potential early adopters in each market
  • Pricing research and development of revenue model

Stakeholder engagement:

  • Engagement of key opinion leaders and influencers
  • Product demonstrations
  • Product seeding
  • Centers of Excellence development
  • Product training and clinical applications support

Controlled launch:

  • Systematic targeting of early adopters
  • Generation of early sales leads
  • Exposure at congresses and in the press
  • Set up and management of distribution network

Full commercial roll-out:

  • Evaluation of results from controlled commercial roll-out and adjustments as required
  • Expansion to additional markets, including identification and signing of country partners

 

Medical marketing & communications
From strategic marketing to medical writing, we provide comprehensive medical device communications services, including:

  • Strategic marketing
  • Key opinion leader management
  • Creation of strong evidence-based product messaging based on clinical study findings
  • Medical writing including peer reviews and trade articles
  • Podium presence 
  • Medical education and webinars
  • Newsletters, targeted emails and brochures
  • Consumer and trade PR 
  • Websites and social media