JALEX approaches the regulatory strategy from the eyes of people who do the engineering. If they are supervising the regulatory strategy, they understand common pitfalls that can occur during the regulatory process, and they are in a position to get in front of them.
Joseph Drain, M.D.
Prichard Medical is an orthopedic device company founded by Joseph Drain, M.D. Dr. Drain designed and built a working prototype of an orthopedic device but needed assistance with a regulatory strategy to get FDA clearance.
Dr. Drain had preliminary discussions with several regulatory teams when a contact through an entrepreneurial support organization in Cleveland, Ohio, recommended JALEX Medical. After meeting with JALEX, Dr. Drain felt they would be a great
strategic partner because of their size and unique expertise.
“There are a lot of companies that do regulatory strategies well. But because JALEX is a little smaller, they are more of a strategic partner,” said Dr. Drain. “They do engineering, as well, and have a lot of domain expertise in orthopedics.”
JALEX Medical’s engineers have an in-depth understanding of product development and regulatory affairs, which creates a smoother and more efficient process. This is one of the reasons Dr. Drain partnered with JALEX Medical.
Dr. Drain has been working with JALEX Medical for several months and expects the relationship to continue for the foreseeable future.
