Companies that outsource medical device manufacturing can either parse the production work among several providers or unify the effort from a single source. Both tactics have advantages, but the use of multiple suppliers can have expensive downsides.
Thomas Black, B. Braun Medical
Medical device manufacturers have a wealth of resources available to handle outsourcing production needs. Experts-for-hire can address everything from design and engineering to assembly and legal/regulatory reviews. There are advantages to adopting this business model, including partnerships with service providers who are adept at their manufacturing specialty.
However, more often than not, the decision to use multiple suppliers on a medical device can have a variety of unintended consequences. These drawbacks can delay a project timeline, increase costs, lower finished quality and create undue workload and stress for the internal project team.
A vertically integrated, single-source contract manufacturer has many benefits.
Reduce supplier audits and validation
Consolidating design and engineering functions with manufacturing provides significant synergies.
The design team will lean heavily toward materials and components from suppliers who have already been audited and are part of the company’s existing supply chain. Similarly, engineers will generally design devices with pre-validated components and materials from these suppliers, eliminating the time and expense required with the validation process.
Engineers intimately familiar with their manufacturing processes understand how to design to make the most of their equipment and processes while minimizing manufacturing variability. Smart design can imbue a product with a standard of quality from the outset.
Planning in this way can accommodate requirements for functionality (the ability to sterilize a valve or tube, for example), clarity in documentation and quality-control metrics.
Reduce management time
Working with an integrated contract manufacturer eliminates the need to manage multiple vendors and the time associated with that management. One project manager is responsible for the entire timeline from the earliest design stages through assembly and sterilization.
A single-stream supply chain also alleviates managerial concern for accountability. With an integrated manufacturer, there’s no question about who is responsible for resolving an issue. As one client has expressed, he likes having “…one throat to choke.”
Prepare for a long product lifecycle
An integrated contract manufacturer can deliver benefits over a longer product lifecycle. For example, a contract manufacturer that also provides sustaining engineering capabilities will be better able to address improvements, enhancements and changes to the product as feedback returns from the field.
Likewise, the longer an integrated team works on a medical device from design through production and sterilization, the more institutional knowledge they can provide. A vertically integrated contract manufacturer acts as a full extension of the customer’s team to provide critical insight and history about everything from material selection to engineering.
Which model works best?
Of course, there is no one model that works best for every company. Some might opt for an approach akin to selecting a group of “All-Stars” to play together on the same field or court. However, judging from the lackluster level of teamwork evidenced in such sporting events, that direction might not be ideal for something as critical as a medical device.
As the design, production and distribution of medical devices become increasingly complicated and regulated, there is tremendous value in consolidating resources with a single contract manufacturer that can provide an integrated team to steward a product from conception through many years of production. The long-term benefits in terms of time-to-market, overall quality, thoroughness of documentation and accountability will typically outweigh any perceived short-term benefits of a multiple-source approach.
Thomas Black is VP of the OEM and international sales divisions of B. Braun Medical, where he has spent the past 36 years of his career. He is a graduate of the UCLA Anderson School of Management and the University of South Carolina-Columbia, where he obtained B.S. in Finance.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.