Professor Laurie Rowe explains her journey from medical device engineer to regulatory expert, while outlining the focus of her company Red Medtech.
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Woman checking the dimensions of the component made in the 3d printer by caliper. Quality control
Tell us about your career in medtech?
Today, I have over 20 years of first-hand practical experience within design, engineering, product development, quality manufacturing, regulatory management, and project leadership with some of the leading medical device companies. I specialise in medical technology device development, as well as quality systems and regulatory affairs, in all sizes of business and across a wide variety of device types and technologies.
Why did you choose medtech and what motivates you?
I love innovative technology and really enjoy working with fellow technologists. We share a genuine passion for the technology and the cause behind it. I wanted to help others, and medical device technology is a challenging and demanding industry, which I relish. Ultimately, I decided early on that I wanted to use engineering for good. Having that ethical clarity of purpose means I can wholeheartedly embrace what I’m doing, knowing that I’m helping people to help people!
What projects have you been working on?
I’ve been working with SERG Technologies, who are innovating Parkinson’s Disease care. The project is a digital health platform for monitoring and managing the symptoms of Parkinson's Disease. Combining wearable tech with AI techniques applied to collected data is a fascinating space to work in. Parkinson’s is complex, lifelong, and incurable, with a range of Parkinsonian symptoms are often common in other neurodegenerative disorders. The potential for sharing and applying data to other areas for the benefit of even more people is super exciting.
What is your proudest achievement?
I have two! When I received the Kathbert Trophy from the IED - Institution of Engineering Designers, that was a really proud moment. The award acknowledged that I “made a significant and developing contribution to design, which has led to a tangible advantage to commerce or society”. As somebody who gets up every day to try and help others, it was a good feeling.
More recently, I was honoured and delighted to become the first female visiting professor at TEDI – London: The Engineering & Design Institute. The opportunity to give back is something that I’m really passionate about, and I am keen to support the next generation of technologists in our industry.
How do you stay up-to-date with the latest trends and developments in your industry?
Continuous professional development is something that all engineers should be doing as a matter of course. I would say training is vital, so aim for the best quality of training that you can afford from an industry leading provider, such as a Notified Body. Also staying up to date with industry developments - I always have a copy of Med-Tech Innovation News on my desk!
What are the current challenges in medtech?
Many people face challenges around the changes in regulations, and it’s an area where we support many of our clients. Although challenging, I’m supportive of the updates because they're all geared around improving patient safety.
There are new UK regulations pending, and now that we are no longer part of the EU, the separate requirements add another layer of complexity. The transitional arrangements for both the UK and EU regulations are welcome, and we are helping clients navigate the compliance landscape for both new product development and MDR remediation projects.
It would be nice to see more international alignment to make things easier on manufacturers. Internationally, we support customers with the Medical Device Single Audit Program, and I’d love to see the UK become a member of that. There are some great international development and harmonisation initiatives underway - anything that aligns global requirements for patient safety everywhere is a good thing.
With the impending new regulations, there will be additional and more stringent requirements, and that's what we help clients with at Red Medtech. However, we’re not a pure quality regulatory company - we deliver impact to clients because we’re able to provide a holistic approach across the entire process, combining the full development journey and compliance. It’s our sweet spot!
How do you see the industry evolving?
There are two big trends that I'm seeing: One is the continued adoption of eQMS and emerging digital regulatory solutions. Digitalisation and optimisation of company processes is an area in which we excel at Red. The other key trend in development is the embracing of artificial intelligence and connected healthcare which is a really exciting space. Smart wound care is a good example, where sensors are used to gain better quality patient data which drives improved design, better user centric devices and patient outcomes.
What's next for Red Medtech?
At Red, we are in an exciting phase in our evolution - this year we turn two years old which I’m excited about celebrating. Myself and the team are always looking for new and innovative projects that will benefit from our experience and support.
We are growing both our internal team of subject matter experts - the Red Allstars - and our external partner network of approved suppliers and manufacturers - the ‘Red Network’. We only work with trusted, exceptional people and companies - those who share our high standards, values and characteristics because it’s not just about what you do, it's about how you do it! To become part of the Red Allstars or the Red Network constitutes the gold standard within the medical device technology industry.
We are delivering successfully for clients using trusted methodologies within the ‘Red Framework’ - our holistic and agile project leadership process. Our approach provides trusted expertise and support for every stage of the product development journey, from concept to market. It is the culmination of all our experience to date and what makes us unique in the marketplace - the fact that we are so experienced in engineering and product development, as well as quality & regulatory elements.
We enjoy a team approach by working in collaboration with our clients. With mutual accountability, we share a common goal and purpose. It’s our agility in applying our tested framework to any or all parts of the product journey, depending on the client’s unique requirements, that makes us so successful in taking products to market.
However, the medical device innovators and developers are the stars of our industry - they are the people pushing the frontiers of healthcare technology. My role is to facilitate, by providing the development leadership required to get the product successfully to market.
I love getting immersed in anything new, and I’m always looking to expand into different areas of medtech. Prosthetics is a really interesting area to me, as is intelligent wound care. There’s also more to learn and develop around combination products that marry pharmaceutical drug delivery with medical devices, so watch this space!
Red Medtech will be exhibiting at Med-Tech Innovation Expo at the NEC, Birmingham, on 7-8 June at Stand E25. Register for FREE at www.med-techexpo.com
