Covance
Lifecycle Product Development is Now Possible

Today, the medical device and diagnostics (MD&D) industry is advancing with transformative breakthroughs, such as machine learning, AI, wearables, and mobile and home health devices and applications. While exciting, it is also an unchartered territory, where new, changing, and more stringent regulations are bringing more complex trials, longer timelines, and higher R&D investments. In this dynamic landscape, medical device companies seek new approaches for their product development process.

Now, it is possible to implement a coordinated effort that integrates the four core components of the medical product lifecycle—preclinical, clinical, regulatory, and post-market. This is where having an experienced partner to collaborate with can make all the difference. As the contract research organization (CRO) of diagnostic laboratory giant, Laboratory Corporation of America Holdings (LabCorp), Covance fits this role perfectly. From preclinical testing and clinical trials to post-market monitoring, the global company helps MD&D organizations advance with a holistic development plan—propelled by a strategic and regulatory-driven approach.

Cheerag Shirodaria, VP and GM who heads the medical device and diagnostics group at Covance says, “LabCorp acquired Covance in 2014 to improve patient recruitment for clinical trials, enhance the efficiency of the development process, and deliver data more quickly to trial sponsors, physicians, and patients.” By combining LabCorp’s leadership in laboratory diagnostic services and its know-how in end-to-end contract research and development at Covance, the company today not only is a leading CRO to the drug development industry, but also has a group dedicated to the medical device and diagnostics marketplace offering a full portfolio of MD&D development solutions. “It may surprise some to learn that Covance, a top pharmaceutical CRO, also offers extensive research solutions for medical device and diagnostics,” says Shirodaria.

It may surprise some to learn that Covance, a top pharmaceutical CRO, also offers extensive research solutions for medical device and diagnostics,” says Shirodaria

The fact is, the MD&D experts at Covance bring more than 30 years of experience in the medical device and diagnostics product development field—having conducted more than 500 studies, touching an estimated 110,000 patients in the last five years.

Talking about the current MD&D landscape, Shirodaria informs, “There are many new and changing regulatory requirements today, which make it arduous for MD&D providers to navigate forward efficiently. We aim to change all that.” In such a scenario, the Covance MD&D team helps device manufacturers optimize their product lifecycle across preclinical, clinical, and post-market stages. The company’s holistic approach helps clients reduce timelines and risks while progressing seamlessly. “Our focused team brings together scientific insight, regulatory guidance, and program management for the smooth development of device and diagnostic products,” explains Shirodaria.

As a part of Covance’s continued mission to enhance its offerings through strategic acquisitions, the company recently acquired Regulatory and Clinical Research Institute (RCRI), a device-focused CRO with strong regulatory consulting and clinical trial expertise. “This company merger uniquely positions us as a MD&D development powerhouse—combining trial execution with deep experience to expedite approvals with major regulatory agencies and notified bodies,” mentions Lisa Olson, president of RCRI who now is an executive leader in the MD&D group at Covance.

Going forward, Covance will continue to create new tailored approaches that will not only enable MD&D manufactures to bring their products to the market faster, but also optimize the device development process. “Medical device and diagnostics development fits naturally within our DNA as a diagnostic testing and trials business for both LabCorp and Covance. As the lines continue to blur between drug, device, and diagnostic testing, our company sits at a unique intersection to bring you transformational insights and solutions,” concludes Shirodaria.