It is projected that by 2050 there will be 1.5 billion people aged 65 years or over, worldwide. This is one of many factors accounting for the projected 14.6% annual growth of global outsourced medical device manufacturing over the coming years.
Recently, there has been an increase in acceptance of contract manufacturing services in the medical device industry to improve manufacturing capabilities and device development, optimize supply chains, reduce direct expenditures and balance rising operating expenditures.
This article outlines the top concerns and considerations for OEMs when outsourcing medical device production in 2022.
Many companies have likely discussed the option to outsource medical device production and, if the decision to outsource a project has been made, it has likely stemmed from one, or all, of the following reasons:
You’ve made the decision to outsource. Now What? What, exactly, will determine the team’s overall success? Success begins with finding the right partner, and there are additional factors to look at when looking for the perfect match.
When sourcing your next partner, ask yourself these questions:
Ensuring your potential partner has a well-established reputation and experience is a good start, but it doesn’t necessarily ensure a project’s success.
There are benefits to outsourcing both pre- and post-market, what is the ideal time to outsource for you can depend on many factors.
When you outsource pre-market, you gain the flexibility to alter the design, which allows for better manufacturability without the limitations that may be set forth from current deal structures.
When outsourcing post-market, you have the ability to improve based on user feedback, while using funds from a revenue stream that is already in place.
Developing a working relationship with a partner throughout a project is not an easy feat – it’s a complex and multifaceted undertaking that can be challenging for all involved.
When outsourcing, it’s important to ensure that you’re fostering a working relationship that is both cooperative and mutually beneficial, with a clearly defined communication plan that encourages accountability and honesty. This is the key to ensuring a harmonious relationship and maximum productivity for all.
Issues are bound to occur in almost every project with every OEM/CDMO relationship. The important thing is that both parties are able to respond efficiently to these issues and overcome these inevitable challenges. Setting a clear structure for communication at the very beginning is essential to maintaining a productive and healthy work relationship.
Although finding a CM based on the market isn’t necessarily a traditional consideration when it comes to outsourcing, finding a CM that thoroughly understands the device market can come with certain advantages.
An example of this would be when China’s MAH policy allows an OEM to market a product as “Made in China, For China” without the OEM actually needing a physical presence in China to do so. Read more about how to access the Chinese medical device market.