Medical Device Co. Seeks Niche Lab Expertise to Integrate Newly Acquired Products

Client Profile

A leading innovator of medical technology worldwide.

Market Overview

Propelled by the digital transformation and ongoing technological advancements, medical device companies continue to introduce even more innovative products and services to the market. These advancements are vastly improving patient outcomes and expanding growth opportunities in an already bustling industry.

However, between STEM talent shortages and increasing demand for capabilities in niche fields, like biocompatibility and toxicology, attracting and retaining qualified people to do the work remains a persistent challenge. Especially now as medical device companies try to meet EU MDR requirements with only a scarce pool of experts in that field to pull from.

The Client Challenge

Our client, with an already shorthanded staff, needed to integrate several product lines they'd recently added via acquisition. They lacked, however, toxicologists and biocompatibility specialists to ensure these newly acquired products were safe, effective, and in compliance with regulations.

Without a solution, the client potentially faced having to pull these products from the shelves, resulting in lost revenue, reputation, and market share.

The Actalent Approach

The client engaged Actalent -- with our extensive industry knowledge and unparalleled supply of talent — to assemble and deploy a team of expert consultants to solve their problem.

Comprised of three best-in-class biocompatibility specialists and a DABT-certified toxicologist, our team methodically went through each new product line and determined which devices could be integrated seamlessly and which needed additional testing.

Next, our consultants established testing and biosafety evaluation protocols that strictly conformed to the client's specifications and standards.

Then, after collaborating with the client, the team assigned due dates to each report and went to work.

Initially, collecting the data posed the most difficulty. It was scattered throughout multiple systems left over from prior acquisitions. Some of our document requests took months to be turned around. But once they obtained the necessary information, our team was still able to complete 95% of the reports on-time.

The Results

Our team performed Toxicology Risk Assessments and BioSafety Evaluations on all newly acquired product lines. Once cleared, each product was properly integrated into the client's existing portfolio without risk to safety, compliance, or revenue.

Actalent not only solved the problem with top-graded results, but we also left the client with a valuable roadmap for integrating their products with confidence and efficiency moving forward.

"We are pleased to acknowledge Actalent's contribution in the successful remediation of 29 implant systems, comprising approximately 1,900 stock-keeping units (SKUs), as well as 33 instrument systems, consisting of approximately 1,300 SKUs," said one of the client's Senior Managers. "This remediation effort enables us to continue the supply of these products under the European Medical Device Regulation (MDR). We are committed to ensuring the safety and efficacy of all of our products, and this remediation effort represents a significant step in achieving that goal."

Beyond the results, the client was impressed with Actalent's overall knowledge of the industry and our ability to source top talent from all over the world, which for this project included two highly regarded experts from Minneapolis.

Equally impressive to the client was how knowledgeable our consultants were about the science, the process, and industry standards.

Today, the client's uncertainty prior to Actalent has been replaced with trust knowing we offer customized, niche solutions that deliver immediate, direct, long-lasting impacts.