Medical Device Design Transfer Challenges

Hundreds of OEMs including market leaders partner with contract manufacturers to manufacture their creations. The trend to outsource has grown over the years, beginning with the manufacture of single components into the manufacture of entire products. Contract manufacturers often build up extensive experience with specific design and production technologies, which has transformed contracting between OEMs and CMs into a trusted and strategic business relationship.

Medical device OEMs usually make the decision to outsource as a solution to tight production capacities. Priority products are preferred to be manufactured in-house while products with smaller market share and that do not form part of the core business are outsourced. This does not imply that these outsourced products are of lower quality by any measure. Rather they are manufactured to the highest standards. When two distinct organizations partner to launch one product into the market, the design transfer stage is the most critical.

Why is Design Transfer of a Medical Device Important?

Given that the entire launch of the medical device depends on the effectiveness of the designer transferring the ‘design’ to the manufacturer, the design transfer stage is perhaps the most important stage of the medical device manufacturing process. Adherence to timelines, successful production, and subsequent launch of the product into the market, hinges on the effectiveness of the design transfer stage.

In this article, we look at what it takes to launch a medical device in your market, and how the right manufacturing partner can assist in this process.

Design Transfer Challenges:

Regulatory compliance

The FDA sets out clear requirements for what documentation and resources need to be supplied to the manufacturing department for a successful design transfer. These guidelines can be found in the ISO 9001, ISO/DIS 13485, and FDA QSR Section 820.181. Are you seeking a 501K (regulatory approval for a device that is similar in function to another medical device that has received its approval), it will not be as stringent as a PMA (Premarket Approval) or approval for a new product (NPI or New Product Introduction. If one or more of these requirements is missed, then design transfer cannot proceed without rectifying the unmet requirement.

Documents such as the DMR, DHR, etc. are a lifeline during and after the design transfer phase.

On the other hand, if an experienced contract manufacturer were included during the design phase, the device could then be manufactured without any delays.

Design maturity

Since the transfer is a lengthy process, there can be times when you get a head start on the design transfer phase – preparing documents and resources to be shared with the contract manufacturer. However, once the design is finalized, it takes a great amount of time to verify that every aspect has been updated in the documentation, and is ready for design transfer. If partially finalized design specifications reach the production team, they will most likely not be able to start work, or having started, be forced to wait till finalized designs, material supplies and production processes are obtained.

Production planning

As the design is verified and tested on a series of prototypes, a number of factors need to be considered. When you production has to be planned, the CM is the one to consult. Better yet, if the CM was responsible for design and production, his expertise in the below matters would be invaluable during the design, manufacture and testing of prototypes, as well as the production for the market stage.  

  • What raw materials the manufacturing department requires based on required product characteristics
  • Are these raw materials available from the vendors list, ordered in advance and stocked
  • Are required parts premade or custom made (since many prototypes use custom-made parts) based on the CM’s specific manufacturing line capabilities.
  • Are pre-made parts at the end of their lifecycle? What feasible alternatives do we have?

A CM handling the design phase will be able much more effectively to include production, sourcing, and other manufacturing aspects, the production process is quicker, under budget with no need for redesigning.

Your Solution to Design Transfer Woes:

The solution is to engage with a contract manufacturer who has extensive experience and has the exact expertise that your medical device needs. Quasar has a 3-decade rich history in delivering full medical devices from design to scaled production and delivery (start to finish).

With Quasar’s experience, you will gain the benefits of superior mechanical design services, electromagnetic design services, and manufacturing and packaging services. Quasar’s technology center in Israel (a country known for its cutting edge innovations), has a team known for breakthrough innovative designs, who will work with you to design your product and manufacture it under one roof.

Involving Quasar therefore right at the beginning will help you cut down development time, get to market quicker and enjoy customer satisfaction in record time.

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