What Is Medical Device Contract Manufacturing?

When it comes to medical device contract manufacturing, finding the right fit is crucial to your success. In addition to manufacturing your product, medical device contract manufacturers provide ongoing support throughout the product life cycle, for quality assurance and regulatory compliance.

In this article we break down the key areas to focus on when assessing a medical device contract manufacturer to be the right partner who can go the distance.

Choosing The Right Manufacturing Partner

Accountability

The OEM is held accountable by healthcare authorities for its quality standard. In the event where a quality issue arises, the OEM in partnership with the contract manufacturer must work together to respond and remediate all quality issues. Therefore, choosing a manufacturer with an exceptional quality track record and after-sales support is crucial.

Quality Inspections Support

Whenever your product is fully audited for manufacturing by authorities such as the FDA or EMA, the auditors will visit the original medical device manufacturing site(s). Any issues or inspection observations will need to be addressed and resolved expeditiously to avoid product availability disruptions.

Product Dossier Support

Comprehensive regulatory filings and subsequent approvals are critical elements to a successful partnership with a contract manufacturer.  Regulatory submissions (510(k) and CE Mark), as well as regulatory services including the Design History File (DHF), technical file, design dossier, product classification/identification, product labeling / IFU, risk assessment, are key elements to selecting a contract manufacturer. Subsequent to manufacturing launch, regulatory reporting remains an ongoing requirement including Complaint handling, Investigation of complaints of adverse events, Medical device MDR & MDV reportable events, and Supplemental/follow-up reporting. Therefore, it is of utmost importance to verify that the contract manufacturer has a thorough QMS and Regulatory System in place for successful monitoring and documentation.

What To Look For

The manufacturer is an integral part of your medical device’s entire lifecycle, rather than just a starting point. What to consider when choosing a medical device contract manufacturer:

Quality Compliance

The medical device manufacturer has to meet all quality regulations. This includes compliance with all applicable ISO international quality standards, as well as FDA, EMA, and other major body regulations.

In addition, regulatory bodies have also provided the guidelines for OEMs to evaluate their suppliers and purchasing controls. These guidelines can be found in under the FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4. Be sure to familiarize yourself with these requirements before venturing out to partner with a medical device contract manufacturer.

Specialization

The manufacturer should have a specialized manufacturing facility, focusing exclusively in a specific area of medical device production. Ensure the know-how and proper level of service is suitable throughout the various production stages, from line operators to top-level management.

A contract manufacturer who has been in the business of manufacturing medical devices for many years can add valuable depth of design and manufacturing knowledge, along with having established supplier relationships. For example: An experienced manufacturer would be aware of safety regulations and nuances behind using biocompatible materials in your medical device, thereby lowering the chances of medical device misfires or costly recalls. They would also be able to offer you the most efficient production process design that can ultimately save you time and money.

Scalability

A medical device contract manufacturer should be able to support the production of both small prototypes, as well as large scale production runs. This way you don’t have to change manufacturers throughout different stages of the product life cycle.

Manufacturers who have automation capabilities, must be able to change automation programing to suit fluctuating production volumes, especially when production volume forecasts are not entirely accurate.

Adaptability

Medical device contract manufacturing very often requires tailored production techniques relevant to your product. This requires both knowledge and infrastructure to do properly – and can save you a lot of money in equipment expenses.

There are also variations in labor costs, automation, vendor list associates, that facilitate variations in production volume.

It’s to be noted that sometimes Intellectual Property plays a role in a business’ adaptability. You may need to share confidential information with your manufacturer. So find a CM is trustworthy and ensure that your contracts are crystal clear on how you IP rights will be handled under every possible circumstance.

Cost Efficiencies

Cost of production is a key aspect that determines whether you decide to outsource or maintain in-house production. Costs are not just calculated on the basis of cost of resources and equipment, rather it’s a factor of how suppliers’ performance and supply chain issues impact the overall costs incurred.

The implication of a medical device arriving on the market behind schedule, is lost profit and a provided opportunity for your competitors to get there first and take the majority of the product’s market share.

An experienced and established medical device contract manufacturer can help you make the best version of your product and get it out to market quickly, at a reasonable price – that’s something that’s worth investing in.

Transparency

Often it becomes difficult to determine what’s going on at your contract manufacturer’s facility if transparency is not prioritized. Look for a CM who’s a great communicator and has communication policies in place that ensure that you have all the right information available to you at the right time.

For example: if your CM experienced a set-back in their supply chain, would you know about it? Having the right information can help you plan and mitigate risks. You will be able to take intermediary action to ensure that your end-customers are not left to guessing about when their shipment will arrive.

Trademarks of a great medical device contract manufacturer

Quasar is a medical device contract manufacturer, specialized in the development, manufacturing and ongoing support of medical devices with over 30 years of partnerships with the tier-1 device makers.      

Choose an effective, specialized, experienced medical device manufacturer to boost your company’s bottom line.  Contact us to discover how Quasar can become your trusted partner.