OEM/Supplier Issues Roundtable, Part II: Orthopaedic Industry Leaders Weigh in on Commercialization Challenges
As the New Year begins, it’s important that OEM and supplier relationships start off on the right footing. Price increases and heightened regulatory scrutiny mean that clear communication will be needed on both ends for successful commercialization. We asked OEMs to respond to one question regarding the relationship:
As you consider the year ahead, what actions can your supplier partners take to help address your challenges?
Brandon Hipsher, Manager, Regulatory Affairs, DePuy Orthopaedics:It’s important that our supplier partners stay in compliance with the change control requirements of the Quality Systems Regulations. It’s typical for a supplier agreement to contain provisions regarding these requirements, and FDA is very interested in ensuring that manufacturers have robust supplier controls in place. By focusing on change control processes and ensuring that changes are communicated to us prior to implementation, our supplier partners can help us stay in a state of compliance in this challenging regulatory environment.
Kenneth Trimmer, Senior Director, Knee Implant Product Development, Stryker Orthopaedics: The suppliers to the orthopaedic industry must continue to reduce their costs. The challenge they face is similar to that of big orthopaedic companies, which is to do this while improving quality and developing more robust quality systems.
With respect to these quality systems, suppliers are expected to have fully validated processes. Additionally, their quality management systems must be up to FDA/ISO standards.
I also believe suppliers need to bring new manufacturing technologies and materials to the markets that enable the design of higher performance products at lower costs.
Matt Poggie, Senior Director, Applied Technology, Stryker Orthopaedics: From a new product development perspective, driving down the cost of producing implants and instruments is ruling the day. I would challenge our suppliers to offer suggestions as to how they might help me do that.
If I present a design to them, I would be open to hearing from them how that design might be changed in order to reduce the inherent cost of producing it.
Click here to read what the first round os OEMs had to say about product development resources, production time and communication and time and cost reduction.