Design transfer is moving an approved design into production.
How to avoid design transfer failures:
1. Notify everyone on the team that a design transfer when design transfer is being completed (R&D, QA, regulatory, techs…)
2. Design transfer process needs to be defined by the whole team
3. Plan and follow a procedure guideline to help steer the design transfer team
4. Plan and schedule with the product data management tool so that all past projects are located in one location and companies can learn from prior failures.
5. Hire more staff as needed to help through the process
6. Budget extra money
Design transfer is a complex process involves transfer an approved design into production. Every manufacturer should follow procedure to ensure that design is correctly transfer into production specification. Sometime the product team doesn't understand or don't have enough time to create and maintain documents necessary for design transfer. The team should ensure that documentation is complete along with the required verification and validation records .Manufacturers might not get same equipment and procedure as it was planned to use in manufacturing. Design transfer should be a continuous process starting from an early stage where manufacturers observe and learn and lasts to final stage.
One significant challenge to Design transfer is that the design transfer may be understood well by all parties, but there may be a lack of planning how to transfer the product design into a controlled manufacturing environment. This can be a significant problem as there may be multiple delays in the process. Another notable challenge is that the operations within an organization can be disrupted or halted because new procedures and materials have yet to be disseminated to members of the workforce. The effect of this can be detrimental because if the workforce is waiting for the new procedures. If workers are not able to perform, then productivity will be decreased dramatically. Developers can impede Design Transfer by failing to create a vendor supply, one that is approved. Also, developers can create waste by safety liability issue to the manufacturer. Members of the organization( e.g. technical experts) tend to underestimate the cost and difficulty of Design Transfer process and so the process can be halted entirely as insufficient funds and effort can prevent the process from continuing beyond a certain point and it can be terminated altogether.
Design transfer involves transitioning the design from planning stages to production. This is a critical trade-off that requires a few things in order to go smoothly. One is communication between departments, which is essential. Another is a multitude of technical factors, such as proper funds and vendors to work with the company in creating the product. Essentially this is the "rate-limiting step" as it ultimately determines the success of the product and what all the work has been leading up towards.
The design transfer process aims to translate the design of a medical device into a production procedure in which the manufactured device can fully manifest its safety and efficacy in a way that complies with its essential requirements and standards. Essentially, design transfer begins with R&D extending out to a production department while taking the other entities into consideration (QA/QC, marketing, engineering, IT, etc). If there is a lack of communication however, then it is likely that the design will not efficiently be transferred to production in a timely manner or even worse, it might be compromised during the production process, resulting in a defective device that will get recalled.
An online article that covers the importance of the design transfer process states that delays commonly occur in this stage during the review and approval process regarding the documentation that is needed to initiate manufacturing (1). This is most likely because it is easier to authorize documents than it is to approve them, which can occur when one department is too cautious to the point that it burdens regulatory processes. Another technique for effective design transfer is to document every event that occurs during the design process. If a change in procedure has to be implemented, it must be documented, otherwise the mistake is bound to repeat itself. Finally, it is important to select a vendor that is compliant with the needs of the product being produced. This requires hiring a fast, flexible supplier that can account for last-minute changes while taking a risk-based approach (i.e. selecting a vendor that offers its components at a variety of tolerances).
Is there a way to apply verification or even validation steps during the design transfer phase? What other methods can be applied to a design transfer process to improve the transition? Is it necessary to update the design transfer protocol when producing devices from a clinical level to a commercial one? How might the design transfer stage differ between the design for a tongue depressor and a pacemaker in terms of the device's ability to scale up and meet the expected demand?
Reference:
(1) Kirsh, Danielle. "Medical Device Design Transfer: 5 Things You Need to Know" (Nov. 2017) Medical Design & Outsourcing
In any business there must be communication which we all agree in. If there is a specific way or product that the design team need for their design, they must communicate with the rest of the groups because the product may have a unique feature or material for creating the product. Each design must be analyzed and verified before proceeding because any change can product wrong outcomes. Time and cost are problems which design transfer face because if the product they intended in using is expensive materials they must substitute with another or buy it and if there is a change they need to find another product that is a proper fit for the design which will take more time, delaying the manufacturing process.
Design transfer which is an integral process in the early life of a product, it must be well executed for complex medical devices.And as Professor mentioned if it satisfies the FDA quality rules & regulations, the product undergoes the production.
There are some factors which can fail the Design transfer process like business style, difference in corporate culture, quality systems and variety of perceptions.
Here i would like to open up the discussion that what are the other challenges for Design Transfer?Share your views.
I think that the biggest issue in design transfer surrounds the timing and coordination of the device design and manufacturing phases. Given the financial investments and forecasted returns, efficient device transfer can dramatically affect the amount of value a device captures in a target market. In a race to bring a product to market, the time spent working through a botched design transfer could be the time that allows a competitor to bring a similar device to market before yours.
I wanted to expand a little on the comment made about how tough it may be for the buying department to find and approve new vendors because this can be a huge challenge in the design transfer. There usually isn't a problem if an authorized vendor can help with a project. The approval procedure, setting up a binding contract, and billing setup can all be drawn-out procedures though if a new vendor is required. Even the legal contract's setup can take months, on both sides. Therefore, this could pose a serious problem for the design transfer process.
Other challenges that may occur in design transfer include incomplete manufacturing instructions, errors or an incomplete design documents, lack of inventory due to miscalculations for cost of materials, and more. In order for manufacturing to be executed properly, manufacturing instructions are very important for a well-executed product. Incomplete design documents and design controls may cause major delays in design transfer. The miscalculation of the cost of materials may not effect the design transfer directly but will present challenges during the manufacturing process.
