Managing Expectations for a Medical Device Manufacturing Transfer

Have you recently received CE approval, IDE approval, or FDA approval?  If yes, congratulations!  The road to demonstrate product performance and address all regulatory requirements can be difficult.

The design transfer and subsequent ramp to production for clinical trials or full product launch can also be challenging and a variety of issues can prevent success.  Problems can include cost overruns, inadequate inventory, quality issues, and delays to product availability.  Using a contract manufacturer with transfer experience can help to overcome common hurdles in the transfer process.  Good communication with the contract manufacturer is also critical to reduce issues.

The transfer to the manufacturing process requires the completion of a wide-ranging list of activities followed by a final engineering review to assure all requirements are met.  This all takes time and money, which may be in short supply following a design and product approval effort.  An abbreviated list of transfer activities includes the items below. 

  • Process documentation and flow diagrams
  • Lot history record documentation
  • Obtaining material and equipment
  • Manufacturing layout and line optimization
  • In-process and final inspection procedures
  • Operator training and certification
  • Risk analysis
  • Master validation test planning and implementation
  • Equipment and measurement validations
  • Packaging and labeling layouts
  • Vendor certifications and agreements
  • Final label and instructions for use layout

Successful transfer using a contract manufacturer requires consideration of several potential topics. Following are some of the conflicting issues between the product owner and the manufacturer to overcome.

Product Owner NeedContract Manufacturer Need
Time to market needs to be short, to enable early sales and cash flow.
Transfer takes time and requires proper planning, training, process validation, sterilization, etc.

Product availability is critical during early sales, so that sales momentum isn’t disrupted.  Strong preference to stock shelves then pauses as sales build.  Consideration of extended shelf life is important at this stage.

Transfer takes time and requires proper planning, training, process validation, sterilization, etc.

Low product cost is needed to provide adequate profit from sales as promised to investors.

To meet low cost, high volume of components and materials must be purchased.  This requires inventory investment and possible obsolescence if changes are needed. Disruption of production is a risk while finished product inventory is consumed.

Product modifications are a potential need following use by early adopters.  Modifications may be minor to reduce regulatory filing risks.

Even small changes disrupt production, delivery and possible inventory losses. A common example is modifications of labels.

The cost and time for transfer may not have been properly identified early in the development process.  Adequate funds may not be available to ensure a thorough transfer.

Manufacturers recognize product acceptance risks and may not be willing to absorb inventory loss or cover transfer costs.

The common conflicts need to be identified and dealt with in early conversations.  Recognition of the needs and early compromise from each side is important to achieve mutual success.

Following are four actions that can greatly help ease the process when working with a contract manufacturer:

Discuss and document the estimated cost and schedule for the manufacturing transfer of the product early in the design and development process. Update this estimate at each product development phase, especially when the submittal for FDA or CE mark are being prepared and submitted. This will avoid surprises and prepare the product owner for required financing and product introduction timing.

If possible, the product owner should start the marketing and first sales to only selected users and hospitals to allow support of a controlled ramp-up of product inventory. This provides for early identification of the potential product or label updates based on initial user feedback. While this may not provide the lowest possible price, it provides a controlled forecast for production while assuring adequate stock. 

Larger lots of material purchasing will take advantage of lower costs and reduce the risks of extended delays waiting for materials. These large purchases of inventory may require the product owner to pre-purchase material or provide alternative support (e.g. provide a bank-held standby letter of credit) to cover the cost of inventory.  Large lots of product builds, however, is not always necessary or desired.  A moderately increasing product build lot size is suggested to control financial and scrapped product risks.

A common delay of a successful transfer and production startup is due to custom-made parts such as balloons, injection molded parts, and adhesive joints not consistently meeting performance requirements. Often the limited production in the design and approval process is not adequate to discover variations that impact product performance. It can be overcome with vendors being required to perform process qualifications combined with building products made to the extremes of tolerances to assure proper assembled product performance.

These actions require early discussion and attention to improve the likely success of a timely and successful transfer.  While some of these activities may require additional cost and time, they are good insurance to support a smooth and successful transfer process and product introduction

Phil Leopold comments included

March 11, 2019