July 15, 2021

The Top 5 Myths About Medical Device Contract Manufacturing

The Top 5 Myths about Medical Device Contract Manufacturing

With each new project comes the choice of trusting a strategic outsourcing partner or doing it yourself, and both methods have their pros and cons. Certain manufacturers are unsure about not having all of the control over the production and potential IP worries, while others carefully identify a dependable third party to handle the fabrication for the sake of versatility, cost efficiency and a timely turnaround. Each medical device OEM has this choice to make at some point.

In this blog we will look at some of the top misconceptions about outsourcing manufacturing.

  1. Lose all control over the production of our product

    The biggest reason a manufacturer would decide to undertake their own fabrication is the advantage of maintaining full control over all of the individual aspects. The maker will be in charge of overseeing the entirety of the production cycle, but also be fully liable for tackling any delays or mistakesencountered along the way. While it is true that you will lose some control, an experienced medical device contract manufacturer will still provide you a high level of control with the help of a dedicated Project Manager (PM).

  2. No control over intellectual property

    Do your homework and ask plenty of questions when vetting a potential contract manufacturer! There is a security risk to your IP if you partner with the wrong company. An established medical device contract manufacturer will have preventative measures and processes in place to secure and protect your intellectual property.

    Working with a U.S. company allows for legal recourse should any issues arise, however confirming that there have never been any IP issues with the CM you choose to work with upfront would be wise. You can also choose to manufacture one piece of your device in house and outsource the rest of it or choose to do the final assembly yourselves.  Most contract manufacturers are flexible and willing to provide you as much or as little service as you need and want- from subsystem assembly to turnkey manufacturing.
  1. Too costly to switch to a contract manufacturer

    While there may be limited costs associated with outsourcing, those costs are minimal compared to the capital expenses to produce in-house. It takes considerable time to obtain and maintain the equipment needed for production. There is actually little to no investment needed in order to outsource production. Contract manufacturers often divert resources to concentrate in particular areas, and through this specialization they are able to offer prices often far below what an OEM can manage in-house.

  2. Too time consuming to train outsourced workers

    Hiring new employees and training them on equipment and production procedures is time-consuming and expensive. Outsourced labor may need some training for highly specific production processes. Again, ask questions. A more experienced and reputable contract manufacturer will have workers that are already familiar with common equipment and manufacturing processes specific to the medical device industry.

  3. Not enough regulatory compliance oversight

    This comes down to the contract manufacturer… not all medical device manufacturers are created equal. Check to make sure they have a dedicated department or individual that will handle Quality Assurance to avoid any regulatory issues. If handling in-house, you have full responsibility of this task so will need highly trained and skilled personnel that can oversee and handle any issues that arise. A good medical device contract manufacturer will already have experienced personnel ready to handle these tasks for your product.

Today, the best contract manufacturers help eliminate specific customer challenges. They are an extension of their customers’ manufacturing operations and align with them to achieve efficiency and cost savings. Many companies choose a contract manufacturer instead of investing resources and time into setting up space and equipment, hiring and training new staff, and worrying about packaging, testing, and logistics. Additionally, when industry trends change, companies who did not tie themselves down with pre-existing infrastructure have added flexibility and can now more easily adapt to market shifts.

For those who are ready to start working with a reliable electronic and electromechanical contract manufacturer, Sanbor Medical is here to help you!

Contact us and one of our industry experts will work with you on your specific fabrication needs. 

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