How to Choose a Medical Contract Manufacturer

Class 1 Medical DevicesDeciding on the ideal medical contract manufacturer (CM) can be a difficult process, as there are many aspects to consider. Medical device CMs play a critical role in the medical device manufacturing process for original equipment manufacturers (OEMs) whether it’s a need for casting and molding, R&D design, or custom packaging. As a medical instrument company looking for the right medical CM to outsource to, you need to know what will determine a successful partnership.

High-Quality Manufacturing with ISO 13485 Certification

A high-quality system alongside the essential credentials, such as ISO 13485 and MedAccred, as well as having a risk mitigation plan in place is invaluable to OEMs. Having these essential certifications hold CMs to certain requirements that keep them consistently meeting regulatory standards as well as satisfying their customers’ needs. It also means that CMs with these credentials have invested the time, effort, and money to ensure that their quality systems are equivalent or exceed others in their field. Quality is often one of the most important factors in any decision regarding medical devices, so choosing a CM with all the essential accreditations, FDA compliance, and quality focus will save you both time and money in the long run.

A Medical Contract Manufacturer That is a Partner

Great customer service makes all the difference no matter what industry you are in but when medical devices are concerned, responsiveness and open communication are critical. The ability to speak to a real human, not an operator (and the right person to answer your question at that!) will make a CM stand out among their competition. After making initial contact with the business development team, ask to take a tour of the facility and at that time discuss some specific questions with the engineering team. At this juncture, their expertise, as well as their method of communication to your inquiries, will indicate how business will operate throughout the partnership.

Geo-Location and Company Size

Location, location, location. It may seem cliche but the geo-location of the CM will significantly affect the overall cost and quality of the final product as well as the company’s responsiveness. In today’s business environment large companies typically are unwilling to make changes in their process or to client projects in order to accommodate the customer’s requirement. While there may be specific situations in which outsourcing overseas may be the best fit your OEM company, choosing a domestic company that will move quickly with new projects, meet volume requirements and provides on-time delivery will offer the flexibility and reliability needed for a great long-term partnership.

Cleanroom Capabilities

Why should an OEM select a medical device contract manufacturer that has cleanroom capabilities? Simple. CMs with cleanroom capabilities have a lower risk of contamination when devices are fabricated in cleanrooms because all product is treated as if it were a sterile product. Devices made in cleanrooms tend to be better quality and manufacturers often have a higher skill level and diligently take care of the devices throughout the manufacturing process.

Good Contract Manufacturers Will Work With You

It is critical that a CM has a clear understanding of what the OEM’s overall goals are and that they are willing to work with them to better understand and achieve those goals. A CM that can do that, will ultimately be the best fit. Price will always be an important factor in choosing the right CM for your project but other criteria play an equally significant role in forming a long-term and profitable partnership. If you are interested in requesting a sample of BMP Medical’s work or you want to start a conversation with one of the experts, we would love to hear about your project.