Aiming at claiming a larger share of the rapidly growing medical device outsourcing market, CSSi LifeSciences has relaunched that sector of its business as a fully integrated CRO division.
The rebranded medical device section of the company will continue to take “designs, prototypes and products through regulatory submissions into commercialization,” the company promises on its webpage. But as an addition, the company is treading into traditional CRO services, such as data monitoring, biostatistics, and an EDC and CTMS platform, said Jim Sergi, president of CSSi LifeSciences.
Taking pride in its comparatively smaller size, the company believes it can help clients avoid the “large CRO shuffle” and provide cost-efficient services.
“The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements,” said Sergi. The FDA and the EMA have recently introduced new guidance and regulations for medical devices to align preclinical testing requirements for medical devices with those for drugs, which increased the complexity and requirements for clearance.
With experience in navigating medical device regulations in over 100 countries and a portfolio that includes over 250 successful 510(k) applications, Sergi said that creating this new breed of CRO focusing specifically on the medical device industry is a "logical extension" of the company's core life sciences business.
Sergi’s confidence might not just come from a strong belief in his own company, but in the medical device CRO market as well. As Technavio—a market trends research company headquartered in London—predicted in a recent report, the global medical device manufacturing outsourcing market will grow steadily at an annual rate of above 11 percent by 2020.
The report states that because of recent reduction in healthcare budget, medical companies have to cut operational costs and reduce their manufacturing expenses. Since the process of developing medical devices—from design to testing, overcoming regulatory challenges and marketing—requires excessive labor and often high costs, the need for outsourcing will increase. Pharmaceutical companies can rely on the expertise of CROs’ services and at the same time reduce product development costs.
Apparently, CSSi is not the only one who has an eye on the growing medical device CRO market. Just a few days ago, the Canadian preclinical CRO CiToxLAB acquired AccelLAB, an expert on medical devices’ preclinical research.
The company’s medical device branch provides services across all phases of medical device development, including filings to regulatory bodies in the United States and abroad, clinical study planning and monitoring, medical device testing and design history files, quality management systems, and reimbursement.
As part of this new develop, the company is also looking for new staff members to join the team, including a medical director, senior regulatory, biostatistician and programmers, medical writers, study monitors and data coordinators, and a quality manager.
Editor's Note: This story has been updated to include new response from Sergi regarding the reason why CSSi has decided to establish the division now and its staffing plans.