Product development can be more art than science for small OEMs, which do not have internal resources for all aspects of a product’s lifecycle. Lincotek Medical’s expertise in product development is demonstrated with 200+regulatory filings for clearance, globally. Design, regulatory and manufacturing capabilities provided by Lincotek Medical can streamline the process and shorten the time to market.
Medical device development can be lengthy and financially burdensome. We believe an efficient method is critical to minimize costs and time to market. Failure to properly navigate the process and understand regulatory requirements can lead to gross timeline and budget expansion, and may ultimately lead to project failure.
We’ll review how our team provides an integrated experience for medical device development of instruments and implants across all disciplines through a robust QMS, regulatory services, dedicated prototyping, testing with an on-site cadaver lab, design transfer and full-scale manufacturing. These key functions within the company set us apart from other development service providers.
Speakers: Troy Walters, Director of Product Development, and Brandon Miller, Director of Commercial Product Development, Lincotek Medical