As we acknowledge and support International Women’s Day this year, our next Spotlight features one of our prominent female leaders…

Corinne Larke joined us as Head of Regulatory in August 2021. As a Regulatory Affairs SME with a background in political science and a passion for learning, Corinne applies her 13 years’ experience in the medical device industry to create effective compliance solutions for our customers.

In her Spotlight interview below, she talks about her pathway to the regulatory field, the female role models she’s been inspired by along the way, and her thoughts on gender balance in the MedTech industry.

Was it always your plan to work in Regulatory Affairs?

I chose to study International Relations at university because it’s a really broad and versatile subject area. You cover political science, history, statistics, economics, law, social sciences, and sometimes even geography. It was a degree that in a way, helped me understand how the world works in terms of governance and legislative processes.

That really suited me because I like to see the bigger picture. The regulatory field offers this too. We work with so many streams and areas within the development and pre / post launch phases of a device that are all very varied, and I have constant curiosity for knowing a little about each of those areas.

While getting my degree, I knew I wanted to work for a big company with an international footprint. When I moved to Kalamazoo in Michigan, USA, I decided to work for Stryker, a very prominent international company that’s based there.

Tell us more about your move from Europe to the US

I moved to the States in 2008, got my green card and started working at Stryker. Working with Quality processes at the company gave me my first experience of working in the medical devices industry. And whilst it wasn’t a plan to specifically go into the medical field (I just wanted to use my background and my interests), it’s certainly turned out to be the right choice for me.

My first manager at Stryker suggested quite early on how suited I would be to Regulatory Affairs. I took his advice and that’s how I ended up in the regulatory space!

I was very happy for a long time at Stryker. The company has a really strong program for determining people’s strengths and helping them plan their career. My time there allowed me to learn everything from the ground up – going from knowing nothing about medical device manufacturing to working with processes, to then moving into postmarket regulatory. And eventually I found myself in the premarket regulatory space in the development of projects.

What aspects of Regulatory Affairs do you find motivating?

Being in Regulatory Affairs, having access to that bigger picture view I mentioned is super helpful. The more you know about different streams the more you’re able to guide a project team in the right direction. I think regulatory people tend to be perpetual learners, because the more you know about biocompatibility, risk, clinical evaluations, or usability studies etc. the more you’re able to answer questions, guide a team, and build up a solid regulatory strategy. Every new topic you learn about enables you to do your job that little bit better.  

The exchange between different regulatory professionals has always been important to me as well. Whilst you may not work with other regulatory colleagues on your specific project, having touch points with other regulatory professionals allows you to share ideas and gather inputs regarding questions you’re working on. I feel that this kind of collaboration is how you grow.

Continuous learning is so important to me – if I’m not learning I actively miss it. Luckily I’ve been in roles so far where it’s always been something that happens naturally, because you’re presented with new questions every single day. Working in an ever-evolving industry means that as soon as you think you’ve seen it all, something new comes your way. You’re never in the position of doing the same thing twice – because once a device has been developed, it’s onto developing something new – and that’s what we’re here for right?!

Any time new regulations are launched, or regulations change, I always find it fascinating to try and work out what broader impact the changing regulation will have. Having worked on the MDR transition, and on the changing legislation that came along with Brexit, I get really excited about change. And change is certainly constant in the regulatory business.

You obviously have a zest for knowledge – does your passion for continuous learning feed into life outside of work?

Absolutely! I’ve actually had to scale my hobbies back a little though. I used to have so many interests because I like to learn new things, that there wasn’t time to become really good at something in particular.

Who or what inspires you professionally?

In the working space I’ve been fortunate to have a lot of great female role models – at Stryker particularly because it’s a company that’s supported women’s advocacy and women’s networking groups for quite some time.

I was exposed to several female leaders, who weren’t hindered by being female and didn’t have to justify themselves for being in the role they were in. They were all very competent in what they knew, and were leaders with regulatory subject matter expertise, as well as great leaders in a human resources sense.

I think you get the best results from working with people who can guide you or teach you something from a people management perspective, but can also give informed advice that helps you grow as a regulatory professional.

The female leaders I’ve been surrounded by have always been supportive, and hugely proactive in the development of their team member’s careers. They would sometimes see the potential in someone when the person hadn’t even realised it themselves. I’ve experienced this first hand – being given tasks that are potentially out of my comfort zone but being reassured that I’m capable, and I think that inspires confidence and facilitates professional development.

How does the US compare with Switzerland when it comes to gender balance in the RA space?

From my experience in the US, Regulatory is super female-dominated. I think in Switzerland it’s more balanced male to female.

What struck me in the US was how wonderfully normal it was to be surrounded by women in powerful positions. It was never a case of calling out “oh this is a female leader now”. Similarly at Congenius, I don’t feel like the token woman in the room, and that’s a great sign of progress. I rarely think about that kind of dynamic during work – we’re all taken seriously, and we all work together towards a common goal without ever feeling like there’s a gender bias.

Once this sense of equality in the workplace becomes more commonplace and feels ordinary, that’ll signal that we’re getting somewhere on a wider scale in terms of gender balance. But it requires constant work that involves female leaders supporting each other, and male leaders becoming advocates for female leaders. Having advocacy outside of the group that you’re trying to grow or support is absolutely crucial.

And for companies that are lacking in diversity more generally, a conscious decision from leaders needs to be taken to support the minority groups – to consciously hire diversely, and to try to cut down bias during recruitment.

What do you look for in a company when you’re choosing where to work?

It’s very important to me that a company has strong values that align with my own. I look for companies that value honesty, authenticity, and want to simply do the right thing.

Let’s turn our attention to the MedTech industry now – what are some of the Regulatory challenges we’ll face in the coming years?

There are three big areas for the MedTech industry that’ll present challenges from a regulatory perspective.

The EU Green Deal will prompt new regulations, and result in changes for many existing regulations that will impact the medical devices field – for example, regulations regarding substances used in manufacturing, requirements around batteries and packaging, and increased scrutiny for supply chains. Having more repairable and reusable devices rather than single-use devices will certainly be a key focus as well.

Another area is of course the continuing story with the EU MDR, especially in light of the recent deadline extension. The deadline may prolong the transition, but it doesn’t mean that companies can slow down or expect less work – it’s simply a longer process now.

The third area would be around the increasing prominence of Artificial Intelligence. On a regulatory level, AI will present ongoing challenges as it continues to prompt new regulations. But on a broader scale, coming back to the topic of diversity, arguably the AI space has historically been largely dominated by white men, which can lead to product development that doesn’t consider other population groups.

Furthermore, when it comes to historical data upon which to base the AI, bear in mind that, for example, women were often excluded from clinical studies, so a lot of the data is male oriented. From a health practitioner perspective, medical device companies often take inputs from physicians. But if you’re only asking male doctors for input, you’re not hearing valuable insight from a female group.

So, when we then come to build AI on top of this type of biased data, that bias will inevitably perpetuate, and when you limit the diversity of the needs, ideas, and data that you collect, you are ultimately limiting effective innovation.

Finally, what’s the long term goal – do you see yourself in Regulatory Affairs for the foreseeable?

In Regulatory Affairs you’re involved in different aspects where you impact the patient – you’re enabling a safe device that’s right for the patient to come to market. Being able to contribute to making patients’ lives better is an inspiring reason to work in this space. And I think because we see so much in regulatory – seeing beyond the initial launch of the device, we are in the privileged position to help continuously make what’s available better.  

I hope to work in this field for the foreseeable future because it’s something that I truly enjoy. It’d be such a pity to lose access to building such a wide knowledge bank, and I don’t think the regulatory field in medical, pharma, or food and cosmetics will get boring anytime soon! So, whilst the regulatory field was initially picked for me by my boss – it was definitely a wise choice for me.

When I think about what my long term goals are, I take inspiration from one of my early managers. He headed up a large team of women and was very outspoken about promoting women and their accomplishments as well as being dedicated to making sure we had what we needed to be successful. He was receptive to those from every level and showed appreciation for everyone who worked in his department. Humble and approachable, his door was always open to tackle any issue – be it professional or personal. This was something that I found so inspiring and it’s a goal of mine to make a positive impact on those I work with in the way he did.