Services
Here to help small to mid-size medtech companies streamline regulatory approvals and market access through a strategic approach to clinical research and evidence generation.
Fractional Clinical Affairs Partner
Cross-functional discussions are fundamental to good product development. Small teams wear multiple hats but sometimes you need to bring in
external help. Clinical Affairs is not just about the study you need to get approval.
Having input from Clinical Affairs means key questions are asked at the right
time.
These include:
• How does the Intended Use impact on the evidence needs?
• Is it for use by HCPs only or self-administered by patients? Study protocols need to fit with the user group.
• Are the claims you wish to make clinically demonstrable?
• Is there existing evidence that can be used to support a clinical evaluation?
• How does the device fit in the treatment pathway and what does that mean for evidence generation?
Clinical Strategy Development
Clinical strategy to some is about ensuring your data supports your claims and meets regulatory needs. Whilst these are key elements, a good strategy does more. It gives you competitive advantage by supporting as many evidence needs as possible in the most efficient way. Reimbursement evidence needs differ across markets, just as regulatory evidence needs do. Working to incorporate these from the start ensures that you maximise the value of early investment in clinical research and streamline post-approval data collection as well.
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The process:
• Workshop to gather inputs and gap analysis
• Fill gaps in knowledge or align on working assumptions
• Map out evidence needs
• Develop a number of potential strategies and work through pros and cons
• Decide on strategy, write plans, synopses etc to enable strategy execution
Clinical Readiness Planning
Are you ready to conduct a clinical study? Timelines are always under pressure during development and making sure you have considered all the requirements prior to study initiation is key. For example, test data needs to feed into documents that need submitting well ahead of any patients being enrolled. Building this into your timelines prior to engaging with investors or committing to timeframes with any stakeholders ensures a realistic timeline and avoids delays which could make or break the project.
CRO Selection
Choosing the right partner to execute your clinical study can be daunting if you
don’t know how clinical research works and aren’t therefore able to spot gaps or
ask the probing questions. Support can be offered in preparing a request for
proposal and then also in reviewing the responses, discussing those with the
companies involved and reaching a decision that enables you to feel confident you have the right CRO for your project.
Evidence Communication
• Having evidence sitting in your files is great for regulatory submissions, but if that’s where it stays this is a lost opportunity. When developing your clinical evidence, understanding your target audience and how to maximise the publication potential from a study can make a big difference in how quickly key stakeholders become aware of your product. This is all part of building a strong evidence pipeline to maximise the impact of your investment in clinical data.
• If you already have data then support can be provided in terms of looking at how that can be used to generate publications or compliant messaging for promotional materials.
Product Development Support
• Business case review – stress test prior to significant investment decisions (internal or seeking investment)
• A fresh perspective on a project plan can sometimes be beneficial to ensure there is true alignment across all functions in terms of timing, decision-making and documentation. This service is primarily targeted at those who are new to medical device development and can either be a one-off review of the plan (project plan review rather than business case review) or by embedding into a team for a period of time.
My broad experience and involvement in many product development projects over the years (past roles included R&D, technical marketing, business development and project management) enable me to consider projects from multiple perspectives and effectively challenge teams to optimise team effectiveness.