Sean Fenske, Editor05.06.16
Developing a medical device, manufacturing it efficiently, navigating the regulatory environment, and bringing that product to market is an incredibly complex challenge. For many years, this was primarily undertaken by the medtech OEM alone. Fearing its IP may leak out to competitors or, worse yet, counterfeiters, companies avoided collaborating with third-party service providers. Others were concerned with whether an outsourcing company could achieve or even recognize the level of quality required when developing technology for use in healthcare. Still others preferred to have direct control over all processes involved with manufacturing; these OEMs thought the only solution to ensure this was to keep these functions under one roof. The fact that many of the outsourcing firms were experts in supplementing capabilities for the specialized, highly regulated industry was not yet fully recognized by most medical device manufacturers. In many instances, these fears were unfounded (especially as they pertain to U.S.-based service providers). Fortunately, many of those insecurities have since evaporated and relationships between medical device manufacturers and outso
Continue reading this story and get 24/7 access to Medical Product Outsourcing for FREE
Our in-depth coverage includes comprehensive feature articles, industry news, trends, and other developments pertinent to the service provider-OEM relationship. MPO examines the increasingly complex and demanding requirements of managing outsourcing partnerships. From regulatory mandates and manufacturing best practices to market shifts and legal concerns, our website is filled with exclusive content to help device manufacturers and their vendors stay informed. Join Today!
FREE SUBSCRIPTION
