We completed our FDA submission during a federal government shut down and still managed to get the clearance ahead of schedule. I’d estimate five months early.”
Vikash Goel
Cleveland Clinic Innovations, the commercialization arm of Cleveland Clinic, nurtures and spins off breakthrough inventions into stand-alone companies. Vikash Goel is the CTO and founder of one of these companies, Centerline Biomedical. His team of researchers developed a Class II medical device for vascular surgery navigation.
FINDING AN ACCESSIBLE PARTNER
At its inception, Centerline had three employees, none of whom had ever brought a medical device to market. They knew they needed to find an expert to help them navigate the FDA submission process to get the clearance needed to commercialize the product.
After a thorough evaluation process and considering multiple options, Centerline identified JALEX Medical as the partner that
could bring their product to the next level. JALEX offered good communication, attention to detail, and – most importantly – the
accessibility Centerline needed.
WORKING TOWARD FDA SUBMISSION
JALEX became Centerline’s quality and regulatory department, supporting its design control documentation, pre-submission
meeting, 510(k) submission, and initial quality management system.
There were times when Centerline struggled with the path forward, but in having a strong partnership with JALEX and its
President, Jennifer Palinchik, Vikash had more than a vendor; he had a knowledgeable, experienced partner committed to
successfully achieving clearance of the device.
“It was great the way we were able to resolve problems. I was able to call Jennifer, and I don’t know that I could have called the President or CEO of any of the other firms,” said Vikash. “I explained my concerns. JALEX was able to bring in
the business perspective on top of the quality and regulatory perspective and provide guidance. They had a true understanding as to how decisions impacted a small start-up business.”
EARLY SUBMISSION HELPS WITH INVESTOR FUNDING GOALS
As a pre-revenue start-up, Centerline needed to achieve FDA submission. They were seeking investor funding, and the submission was critical for its valuation.
“JALEX was able to help us strategically develop our regulatory pathway so we could achieve early submission, while performing required work in parallel before clearance and marketing of the product. This strategy helped us raise money,” said Vikash. “We completed our FDA submission during a federal government shut down and still managed to get the clearance ahead of schedule. I’d estimate five months early.”
MOVING FORWARD
Five years later, Centerline has two dozen employees, including quality and regulatory personnel. JALEX has moved into a
supporting role, providing post-market regulatory and quality support.
Learn more about Centerline here:
