How to Choose a Medical Device Contract Manufacturer: Pitfalls to Avoid

How choosing the wrong medical device contract manufacturer can be devastating to your business


ISO13485 by Nonaccredited Notified Body (Supplier that have certificate)

Contract Manufacturers

Contract manufacturer’s looking to get into the medical device industry may not truly understand what they are signing up for and this can lead to some awkward and potentially devasting discussions that derail projects and business relationships.

Failure to perform a regulatory gap assessment

Subjected to Unannounced audits

Properly choosing a Notified Body

  • Subjected to additional audits by the client’s notified body
  • Scope of recognized registrar
  • History and depth of audits

FDA Establishment Registration & Device Listing

  • Yearly costs with registering facility
  • Device listing of clients’ product(s) opens up company to FDA Inspection and complying with 21CFR820, as well as other regulatory requirements (i.e. 801)
  • Level of control
    • Not just lot tracking for traceability.  Contract manufacturers need to be aware that medical device requires the stand traceability from a material standpoint, but also from a process, training, and employee training standpoint.  Should there be an issue in the field, clients don’t want to know just what lot of materials were used within the final product, but also what equipment, operators, work instruction versions and verification steps.  This can be a drastic change to the overall day-to-day operations of a business and can fundamentally change the way the business operates.
  • Business Risk Preparation
    • Typically, when considering to bring on a medical device client, the level of business risk is not fully realized until the project is well into it’s final stages.
    • If a medical device client comes aboard, they can be perceived as 90% of the business risk but only account for 5% of the business.  This is crucial to consider whether or not the contract manufacturer really wants to get into the space.
  • Clients considering going into business with a Medical Device contract manufacturers for the first time.
    • Upfront quote and identify requirements early on in the process
      • Ensure the contract manufacturer is fully aware of what they are signing up for.  This can include the concessions for unannounced audits, additional revisions to the quality management system, added resources (labor and consulting), FDA registrations, yearly audits by the client, FDA inspections and compliance with other statutory requirements, such as ROHS/WEEE
    • Risk to both the client and the contract manufacturer
  • Be careful of the “Medical” term when vetting potential contract manufacturer.  I have gone into several contract manufacturers, with the assumption that they have been producing medical devices and it accounts for “10% of their business”, only to find that they are manufacturing components, subassemblies, and accessories to medical devices.  There is a drastic difference between that manufacturing process and producing a finished medical device for a client.  The is an eye opening moment for the contract manufacturer as they only now see the additional scrutiny and requirements needed to support the client and be in compliance.  (Make or Break Moment)
  • My worst moment when vettng a contract manufacturer was when the decision to move forward with this contract manufacturer without the initial input of Quality/Regulatory.  Operations and the CEO made executive decision to heavily invest in the client and setup a production line.  Only about mid-way through the New Product Introduction process did I have a change to go down to the supplier to understand their current processes, meet the team, and conduct a supplier audit to ensure compliance ISO 13485 and FDA 21CFR820.  During the closing meeting of the audit, to my shock, the president of the company (who was present during the meeting) stated that he had no idea that this was a full “medical device” and the additional requirements that were needed. He immediately reacted that the initial quote may be low and the only way to meet these requirements and additional risk were to hire the appropriate personnel, which would ultimately raise the per piece quote.  Additionally, they now have to set up a unique process because the 7,000 other products produced (non-medical) follow their current process without the additional requirements.  They ultimately do not want to interrupt their current business and apply additional requirements for one client that is not a significant revenue generator, as compared to the sum of their other clients.
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