Evolving To Meet The Medical Device Outsourcing Boom

By Bob Marshall, Chief Editor, Med Device Online

A 2017 report by Grand View Research, Inc. projects the global medical device outsourcing market is expected to reach USD $88.2 billion by 2025. The market was valued at USD $33.2 billion in 2016 and is expected to demonstrate a compound annual growth rate (CAGR) of 11.5 percent over the forecast period. Product design and development services, contract manufacturing, and regulatory consulting services are among the key market segments expected to drive this growth.

Regulatory consulting services, in particular, are expected to see high demand during this period, as regulatory requirements intended to ensure the quality of healthcare devices are rapidly becoming more stringent and cumbersome to handle. To meet this need, medical device manufacturers are increasingly turning to regulatory and quality consultants for support.

One of the companies looking to support these medical device companies is Maetrics, a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions. I spoke with Maetrics president Steve Cottrell last year, and again at the beginning of this year, to learn about some of his approaches to serving the medical device market and planning for growth. I asked Cottrell about the services that are keeping Maetrics busy with their medical device clients today.

“The things we are seeing the most - much like other service providers, I imagine - are reaction to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), Clinical Evaluation Reports (CERs), the medical device single audit program (MDSAP), and 13485:2106. But, in addition to those elements and our remediation type work, we have been doing a significant amount of work in mergers and acquisitions. We’ve also been doing quite a bit of work in supplier auditing.” Cottrell said. “One of the things that we are trying to bring to the post-approval regulatory and quality arena is business process outsourcing. We think we can help clients achieve a higher quality outcome with a lower price point and help them achieve their goals on a little bit more consistent basis, versus the classic scenario of – oh my goodness, I’ve got an issue, let me throw everything and the kitchen sink at it to fix it.”

A Little Q&A During M&A Goes A Long Way

Having been a consultant in the device industry, and having seen some companies' struggles following a merger or acquisition, I asked Cottrell for his insight in light of the work that Maetrics is doing in this area.

“If you take a look at what has happened, virtually all of the major remediation efforts have gone into play because of warnings letters. They were the result of a poor decision or an inappropriate evaluation at the quality level of the acquisition. If you talked to people that worked on the other side, it was all out there; there were no secrets about the challenges. They just weren’t addressed. If you don’t do the due diligence up front and negotiate the acquisition cost, you’re probably going to pay three times as much on the back end,” he explained.

Building A Consulting Organization From A Resource Perspective

Cottrell has been with Maetrics since 2013 and has seen change during his tenure as president.

“We pushed somewhat of a reset button about three years ago on our business. The company had been around for 30 years, and we grabbed a tiger by the tail with one of our key major clients on a remediation program. Our organization swelled to over 300 people, but then all of a sudden the remediation was complete, and it was time to turn the wheel to a more strategic direction,” he explained.

“Adapting to the changing needs of our clients is not easy, but we have evolved, and what we’ve tried to do is make sure we have a group of management people in our solutions delivery team that have been with us a while. We now have an average tenure in excess of seven years. The core members of our solutions delivery team are proven, experienced leaders both on the client side as well as the consulting side," Cottrell said. "We have to retain that core group of people and make sure they are ready and able to address client needs as they arise. Also, as a service provider, we are all about our people and focused on the relationship element. Clients often want to sit across the table from or have a discussion with the individual that is going to help them achieve what they need. They need to have a comfort level with the person that is providing them with direction.”

Cottrell also talked about the dedicated resource management function at Maetrics, as well as the importance of having experienced people with strong recruiting backgrounds to quickly find the right people to help his clients.

“So, if a project comes in and the client needs 10 people to work on site for a period of time, we may have some resources available that are rolling off other projects, but we will need our recruiters to help build the right solution team for our client,” Cottrell said. 

He concluded by summing up the approach at Maetrics: “Our goal as a firm is to help our clients achieve readiness so they can stand on their own, rather than having to rely on us for everything. If we are going in to remediate some type of issue with regard to quality or compliance, we help the client re-establish their process and procedures, get them trained on the new process and procedures, hand it back over, and then we walk away. When they need us again, they will bring us back.”