Maria cofounded R&Q in 2008 and has been focused on providing business-balanced solutions from inception. Maria ensures that the R&Q business is strategically focused on growth, R&Q’s vision and mission are upheld, and R&Q is poised for success. Having led the growth of R&Q to a 200+ person firm with an industry-leading reputation, Maria has an expert understanding of the consulting industry, as well as the medical device industry.
Maria has nearly 30 years of industry experience in medical device product development across all areas of regulatory and quality assurance, as well as post-market surveillance and compliance. Maria capitalizes on this experience to ensure that R&Q continues to provide top quality strategic and tactical solutions to the industry.
Stephen Cottrell is the President of Maetrics and is responsible for client service delivery, growth, and overall performance of the company. He leads an experienced team of industry professionals who formulate and deliver consulting services dedicated to the life sciences industry. Steve’s experience encompasses leading a wide array of business services within the life sciences sector, including business process outsourcing, strategic sourcing, and clinical trial offerings.
Steve is a business executive with more than 25 years of experience in the life sciences industry. His career has been dedicated to supporting services in the medical device, pharmaceutical, and biotech market segments. He has a proven ability to evaluate client challenges and bring together unique solutions to meet the current and future needs of clients.
Regulatory & Quality Solutions LLC recently announced that it had acquired Maetrics LLC, forming the largest medical device focused regulatory and quality consultancy serving the life science industry. In this interview, Maria Fagan (R&Q, President) and Steve Cottrell (Maetrics, President), talked to Medical Alley about how they are leading their businesses through the pandemic, and why it was an opportune time for the companies to come together.
Maria Fagan: R&Q is a consultancy founded by a team of women with deep experience in the medical device industry. Since the business was set up in 2008, we’ve become a leading provider of regulatory and quality consulting services for medical devices, in vitro diagnostic devices (IVDs), and combination products. I’m proud to say we now serve over 300 medical device and combination product manufacturers across the world.
Steve Cottrell: Maetrics focuses exclusively on providing comprehensive regulatory and quality compliance solutions for the life sciences industry. At Maetrics, we have a hands-on approach combined with decades of experience with global regulatory requirements and involvement with regulatory body committees. We’ve expanded our reach since the business was first founded in 1984 to include offices based in the U.S., U.K., and Switzerland.
MF: The most significant change has been an increase in proactive communication with clients and internal team members. The core leadership team had daily meetings to review the situation and how it was progressing, and we had weekly company-wide updates to keep everyone informed. There was a lot of uncertainty right from the beginning of the crisis, so it was critical to remain calm and reassuring, and keep up with the constantly changing developments.
Our immediate priority was to check across all our client contracts to make sure all our billable allocation was being used up — to the clients’ benefit. We were determined to hold on to our fabulous people despite the market disruption, so we made sure all of our resources were occupied even though there was a pause in some usual activities. In fact, we started many internal corporate programs seeking out additional process efficiencies, which the teams really enjoyed. Though we were advised that we may need to furlough employees, we chose not to, and it was fortunate that we made this choice as things turned positive again very suddenly by about June.
SC: It’s a very dynamic time and industry! An event like this affects each of us in some shape or form, so making our field employees feel supported has been paramount. In unexpected situations, we have to remain both optimistic and realistic as leaders – any uncertainty or a lack of confidence in the future of the business trickles down to employees, adding to the concerns they already have. Indeed, it was important to communicate reality as well as the positivity that we genuinely felt as leaders, especially as we saw very little impact in terms of the client projects we were working on and had in the pipeline.
MF: During our daily team meetings, we came up with a four-pronged approach: increase revenue; reduce unnecessary expenses; ensure that customer and corporate projects are on track; and check on our people’s wellbeing. The revenue pillar of our strategy is where our acquisition of Maetrics comes in.
SC: The onset of COVID came after we began discussions with R&Q and there were of course some concerns about going through an acquisition at this particular time but frankly, it was an opportunity we couldn’t pass up. The value of the combined organization and the opportunity that the combined organization brings will help clients, employees and patients in the future. The integration of R&Q and Maetrics really is a unique opportunity to create an international regulatory and quality powerhouse. The fact that we have been able to achieve this acquisition despite only meeting in person once because of COVID-19 is a real testament to how well-aligned the company cultures are, and how smart this decision has been for everyone involved.
MF: Effective integration is a key priority that we’ll be paying close attention to in the next year. Our focus will continue to be on revenue growth across the US, but our top priority is expansion in Europe. Our clients are increasingly looking to us for their ongoing clinical and post-market surveillance needs and we are preparing the combined company to meet these needs in 2021 and beyond.
MF: Spotting talent and pulling the right people together is an important skill. I also try to stay abreast of what’s happening in the industry and continually set the vision for our business. And lastly, our golden rule is to treat people well, regardless of their role or seniority.
SC: For me, leadership is rooted in the ability to serve the people who are part of the organization, and ensure they are always given the support they need. That has always been a recipe for success in the services business.
MF: The worst advice I’ve ever been given was to stay safe and avoid risk, but I chose to take the path that makes me happy. Of course, I have a Plan B, but haven’t had to use it so far!
SC: The best advice I have received is to always “listen with two ears and speak with one mouth,” and to use this philosophy to serve others. The worst advice was to make sure that people are fearful of me as their leader. Maria and I agree that fear has no place in our culture.
MF: Launching R&Q in 2008 alongside my partners Lisa Casavant and Robert Markley was a real highlight. Another important moment was bringing the private equity firm DFW on board – they’ve been fantastic. And finally, bringing in Maetrics and working with Steve – I’m amazed at how well the teams have merged.
SC: Getting through these last months and what we have achieved has been hugely rewarding. Prior to that, it’s been a real pleasure to witness the fabulous progress some of the individuals I’ve had the chance to work with have made in their careers. They started their career and then took the opportunity to develop and grow, and now they work in executive roles in other firms, truly wonderful to see their success.
MF: Sleep more and eat right!
SC: We’ve been doing a lot, but I’d like to take time to think more, and read more.
SC: I go out on the water and fish. This year it’s been phenomenal – with the reduction of pollution in our oceans recently, the water has been the cleanest I’ve ever seen it. In fact, we’ve even seen breaching humpback whales within hundreds of yards off the coast of New Jersey for the first time in my lifetime.
MF: My husband is really funny so he helps me to relax. I try and do yoga in the morning to get moving before I start my day. Or I take a nap! I also enjoy reading about the experiences of my peers and think about how that can be applied in our business. Real leaders never cease to learn.
MF: Medical Alley is doing a great job not only from a political perspective, in influencing policy and procedure, but also in bringing medical device groups together.
SC: They are truly working to find good solutions, by partnering with manufacturers, service providers and other stakeholders to bring a range of topics to the table in an inclusive, positive and engaging manner. For me, this is what makes the Medical Alley community unique.