Considerations when outsourcing manufacture of medical devices

Considerations when outsourcing manufacture of medical devices

In the modern era of manufacturing its common for a company to make the decision to outsource part or full manufacturing of medical devices to a sub-contract manufacturer/critical supplier. There are many reasons for the medical device manufacturer to do this i.e. expertise, scale of manufacture, latest technology and cost. Its vitally important to select the right sub-contract/critical supplier manufacturer.

How to find the right sub-contract/critical supplier manufacturer:

  1. Size – This will determine their ability to meet your manufacturing needs, whether this is with specialised equipment or the newest technologies. Consider the number of customers they have, as this may impact how they prioritise or schedule your manufacturing requirements.
  2. Quality focus – It is important to consider if the sub-contract/critical supplier manufacturer has a robust Quality Management System (QMS) with the required accreditations i.e. ISO13485. Effectively quality is a very important aspect to consider, as the end product must be manufactured in a compliant environment and comply   with the release criteria prior to releasing to the market. The capability of a sub-contract/critical supplier manufacturer to meet these standards should be assessed through at the supplier management program defined in the device manufacturers QMS.
  3. Communication – Communicate clearly to ensure the sub-contract/critical supplier manufacturer understands the specific manufacturing needs and requirements. It must be clearly demonstrated that the sub-contract/critical supplier manufacturer only produces product which complies with the medical device manufacturer’s requirements.. Managing the relationship with the contract manufacture is one of the greatest challenges.
  4. Cost – Consideration for all costs throughout the lifecycle of the product and not just the cost of production at the contract manufacturer should be considered
  5. Location, location, location – Location is a significant consideration in the process, this will contribute to the cost of manufacture.. Also consider ease of accessibility for onsite audits and meetings.

These are just some of the factors to consider when selecting a sub-contract/critical supplier manufacturer organisation, in order to ensure that you are placing the highest quality medical devices on the market. Consider your company as a customer of the sub-contract/critical supplier manufacturer, therefore this is mutually entwined relationship, which has to work for both companies. If possible don’t just consider one sub-contract/critical supplier manufacturer, shop around and select the best suited to your organisation and product needs.

Whatever decision your organisation makes, whether to manufacture in house or outsource, ultimately the legal medical device manufacturer is responsible for both the legal and quality compliance of the medical device.  This responsibility lies with the company (medical device manufacturer) that places the device on the market under its name.