Spotlight on MedTech Commercial Strategy
Interview with Ellie Baker:
PMCF Commercial Director
An introduction to Ellie
Ellie, tell us a bit about yourself?
I am passionate about what I do and enjoy supporting clients bring innovative medical devices and healthcare solutions to life: from early development through post-market strategy. I take pride in making the complex more manageable. Out of work, I’m a mum to three energetic boys, a lifelong animal lover, and a bit of a sport addict – I’ll give almost anything a go!
In your spare time, what do you enjoy doing?
I love running and riding, and making the most of the beautiful area I live in. My happy place is a walk on the beach or watching the sunset with family and friends.
If you could have one superpower, what would it be, and why?
I often dream of flying; it feels like the ultimate freedom, the ability to just take off and go wherever you want. That, or moving at lightening speed! Both would give me the chance to be everywhere at once, which would be incredibly handy juggling work, travel and family life. Plus, imagine never being stuck in traffic again, bliss!
Ellie’s Perspective - Deep Dive
You recently joined Purdie Pascoe as PMCF Commercial Director. How has your first few weeks been and what attracted you to the business?
The first few weeks have been brilliant. I started with a warm welcome and onboarding, getting to know the incredibly talented team here, and by week two, I was already diving into the RAPS congress. It was a great way to immerse myself in the evolving MDR landscape and hit the ground running.
I have quietly admired the work Purdie Pascoe has been doing for some time. Their reputation for high-quality, insight driven PMR and PMCF support really stood out to me. So, when the opportunity came up to join and lead commercial strategy, I didn’t hesitate.
Why should medical device manufacturers consider PMCF surveys?
PMCF surveys are a cost-effective, MDR-compliant way to gather real-world clinical evidence as part of a robust post-market surveillance plan. They allow manufacturers to collect device-specific endpoints, track usability and performance in real-world settings, and identify any previously unknown side effects or emerging risks. Crucially, they help confirm the ongoing acceptability of the benefit-risk ratio, while also offering valuable strategic insights to support future innovation and market positioning.
What makes the Post Market Survey expertise at Purdie Pascoe unique?
Purdie Pascoe has been at the forefront of PMCF survey delivery since the introduction of the MDR, with over 400 surveys completed (both level 4 and level 8) across a wide range of device types. What sets us apart is not just our PMCF experience, but the fact that it’s built on more than 15 years of healthcare primary market research expertise. We offer a fully end-to-end PMCF survey service, from protocol development through to final reporting, but we are also flexible. Whether a manufacturer needs the full package or support with specific elements like survey design or data collection, we tailor our approach to fit their needs and internal resources.
Client partnerships are at the heart of your role. How do you help guide them through the complexities of the MedTech landscape to achieve their goals?
Building strong, collaborative partnerships is central to how I work. I take time to understand each client’s unique challenges, from device specifics to regulatory pressures, and help turn these complex requirements into actionable strategies. One key way we add value at Purdie Pascoe, is by staying closely aligned with notified bodies. We understand how a weak PMCF strategy can lead to costly CE certificate delays, so we are proactive in keeping up with the evolving expectations. We are also sticklers for rigorous planning, testing and validation. Regular quality control checkpoints are built into every project to ensure the data we deliver stands up to scrutiny, and ultimately helps our clients move forward with confidence.
What trends in MedTech innovation are you most excited about?
There is so much exciting innovation happening in MedTech right now, it’s a great time to be part of the industry. I’m particularly energised by the rapid development of digital health, wearable devices and AI-driven diagnostics. These advancements have the potential to make healthcare more personalised, accessible and proactive. It’s inspiring to work with companies pushing boundaries, and to support them in navigating the path from concept to clinical impact.
How is digital health influencing commercial strategies?
Digital health is reshaping commercial strategies across MedTech: it’s not just about selling a product anymore, it’s about delivering a solution that fits and compliments a broader, data-driven ecosystem of care. Commercial strategies now have to consider software updates, data privacy, user engagement as well as ongoing clinical validation in the real world.
From a PMCF and PMS perspective, digital health also creates new opportunities for smarter data and evidence generation via apps, remote monitoring and real-time feedback from clinicians and users. Building trust in digital health through transparency, performance and meaningful outcomes needs to be reflected in the commercial strategy, so it is as agile, patient-centric and evidence informed as the innovation itself.
Having been in the industry for over a decade, in your opinion how has it evolved?
The MedTech industry has changed quite dramatically over the last ten years. Regulatory expectations have become more stringent: notably the introduction of EU MDR, which has placed a greater emphasis on clinical evidence, ongoing surveillance and real-world performance. At the same time, the huge leaps in technology advancement such as connected devices, AI and personalised and remote care solutions, while exciting and revolutionary, they add complexity from a regulatory and commercial perspective. As a result, manufactures need to think more about the strategy throughout the product lifecycle. It’s no longer just about getting to market, it’s about staying and evolving with the right data, partnerships and post-market strategy. And this is exactly where we come in: helping our clients adapt, stay compliant and thrive in this rapidly advancing landscape.
You recently attended the RAPS Euro Convergence in Brussels; can you share any key learnings?
Attending the RAPS Euro Convergence in Brussels was a great experience, and I came away buzzing with valuable insights. One of the biggest takeaways was how essential strategic Post-Market Clinical Follow-Up (PMCF) has become, it's now a key part of the regulatory process, not just an optional extra. We also saw how regulators around the world, including those in the EU, US, and China, are relying more on real-world evidence for post-market surveillance. That means it's increasingly important to think about how data can be shared or transferred across different regions to streamline processes. Discussions also evolved around how the EU-MDR rules continue to pose hurdles, especially for SMEs, with high compliance costs and capacity issues with Notified Bodies impacting innovation and market access. Article 61(10) and the importance of using it correctly was another hot topic; it has been shown that PMCF surveys are an effective tool to monitor and confirm the safety and performance of Art. 61(10) devices once placed onto the market, in cases where collecting pre-market clinical data isn’t feasible or ethical. Overall, the event highlighted the need for manufactures to partner with experts who understand these evolving requirements, and that is where we at Purdie Pascoe can make a real difference.
What excites you most about the work you do?
What really excites me is being part of the journey that shapes the path of innovative medical technologies, from their earliest stages to real-world impact. I find it incredibly rewarding working closely with clients at those pivotal moments, where the right evidence and strategy can make all the difference. I also love that I am constantly learning; every project introduces something new, whether it be a cutting-edge device, novel indication or fresh regulatory challenge. It keeps the work dynamic, meaningful and inspiring!