Making Contract Manufacturing Work for You

Outsourcing production can be a well-justified decision--potentially resulting in reduced costs in infrastructure and resources, greater efficiencies, and reduced overhead. However, there are important factors to keep in mind along the way.

Barry Kazemi

One thing medical device firms should keep in mind is that many contract manufacturing organizations (CMOs) are diversifying their scope of offerings. And nowadays, many of them offer a combination of services. For instance, a manufacturer might also offer package testing, or a molding house could also provide assembly capabilities. But to gain maximum advantage, OEMs should look to partner with CMOs that provide not just a handful of service offerings but a comprehensive variety of them--in other words, they should look for a one-stop shop. Such organizations can allow device firms to drastically reduce resource costs, speed time to market, and streamline vendor coordination. This approach is especially recommended for startups, as such turnkey contract manufacturers could also help them establish an FDA approved quality system and help them navigate the 510(k) or PMA regulatory pathways.

Device companies shopping for a CMO should ask questions such as the following:

The relationship formed with full-service CMOs is more of a partnership, as they have a vested interest to see you grow, having partnered with the OEM in the product's infancy. Beyond basic manufacturing capabilities, an OEM should expect the full-contract manufacturer to possess:

Additionally, a good synergy between the OEM and contract manufacturer is essential for a successful relationship. So when choosing a full-service contract medical device manufacturer, OEMs should look for open communication channels, accountability, and traceability of operations. Taking the time to research and choose a CMO that has all these capabilities goes a long way in ensuring quality product and shorter times to market.

In conclusion, if building internal resources is not a financially viable choice or if the OEM is an emerging company, then choosing an experienced full-service medical device contract manufacturer to handle your manufacturing and related activities is recommended. It not only reduces costs and increases efficiencies, but also ensures that the medical device meets and surpasses the high standards set by the FDA and leaves no margin for error.

Barry Kazemi is the president and CEO of Life Science Outsourcing Inc. (Brea, CA).