Design Transfer is the process of handing off the new product from the design team to the manufacturing/base business team. In my company the design team (along with the manufacturing team) will continue to support a product after launch until the product meets certain criteria for stability. This way if there are issues with the product the design team is still engaged to be able to solve those problems. We have found the first 3 to 6 months after product launch a lot of unexpected problems can arise. This is often due to the ramping up of production to meet the increasing sales demands. What are some other important aspects for consideration during design transfer and handing off the product?
I have no experience with this however, I can provide some insight. For the process of design transfer to be easier I believe status meetings should be done prior to the project being handed off to manufacturing or production. Manufacturing should be part of the planning phase if they aren’t already. The reason I state this is what happens if manufacturing cannot develop the device because there isn’t a technology that can support the production of this product. You have a great idea, but it cannot be produced. Anyways, as mentioned before having meetings regularly and communicating clear and concisely will help with the design transfer.
I agree with krp67 that communication and status meetings are a great start to design transfers. I also believe that organization of all files if very important, making it as easy as possible for the new team to find individual files, etc. All documents must be updated and organized in a fashion that is easy to follow to save the new team as much time as possible when searching for a specific file.
In my point of view some important aspects for consideration during design transfer and handing off the product are:
Safety: The risk to humans or the environment
Accuracy: The difference between the expected truth and the actual parameter
Precision: The number of distinguishable measurements
Resolution: The smallest change that can be reliably detected
Response time: The time between a triggering event and the resulting action
Bandwidth: The amount of information processed per time
Maintainability: The flexibility with which the device can be modified
Testability: The ease with which proper operation of the device can be verified
Compatibility: The conformance of the device to existing standards
Mean time between failure: The reliability of the device, the life of a product
Size and weight: The physical space required by the system
Power: The amount of energy it takes to operate the system
Nonrecurring engineering cost (NRE cost): The one-time cost to design and test
Unit cost: The cost required to manufacture one additional product
Time-to-prototype: The time required to design, build, and test an example system
Time-to-market: The time required to deliver the product to the customer
Human factors: The degree to which our customers like/appreciate the product
The transfer of a product design into a manufacturing environment requires a far-reaching set of procedures to arrange numerous tasks at the same time. Experience, professional techniques, and careful survey are the keys to a successful change. This is particularly evident when a product configuration is exchanged to an outsource manufacturer as a result of the more noteworthy potential for miscommunication. Contrasts in corporate societies, business styles, quality frameworks, and impression of what constitutes design transfer can add to issues.
I think one of the main issues lies in increased customer demands. When the design team first hands off the project to the manufacturing team, a certain plan is made based on the expected demand. Once the product becomes more popular and there is increased demand, rather than manufacturing just scaling up I think it may be important to include the design team in the decision on how to do this. While the manufacturing team certainly has the skillsets to scale up, the design team thinks in different ways and may come up with different valid points. This can be done by having a meeting with the two teams present whenever making a big change in the production of the product.
One thing to consider when handing over a product from development to production is to think about the person that will be assembling the device. During development, the product is generally being assembled by the engineers that are coming up with the design. As a result, the SOP which provides the instruction for the assembly may contain a lot of technical language which an operator on the production floor may not understand. So, SOPs should be written with clear and concise steps that are easy to follow. Sometimes it is much easier to write the instruction using pictures or a schematic rather than a paragraph explaining everything. Above all, the goal is to have a final product which is consistently well made according to the design.
The factors that need to be considered during design transfer are that complete information is provided to production about the manufacturing of the product. This includes manufacturing work instructions, Item Master, Quality inspection work instructions, Procurement instructions, drawings, tooling specifications, routers, bill of materials and device master record. Also it should be ensure that all the specifications of the device are verified and validated before going in for manufacturing.
Design transfers are successful with communication and status meetings. These meetings should be used to keep everyone updated and also look at additional documents. Also a key factor would be to address any additional customer needs that were updated. Any of the drawings and specifications for manufacturing updates should be talked about here. With design transfers, it should be made sure that everything is in order for the manufacturing of the product to be smooth.
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.
It is important to note that manufacturing plays a critical role in the design control process. As development completes a project with design controls, manufacturing is managing design controls in parallel to determine how to implement the designs into production. Manufacturing plays an essential roles during this period when transferring designs over to production. With the resources and testing determined by manufacturing, production is better prepared in meeting the demands of a launched product. However, an unexpected customer demand after a product launches can completely disrupt the success of production. Production are given specific resources and requirements to meet, but an unexpected growth in customer demand will not have production prepared to meet the new demand.
There are many obstacles to consider when attempting to ramp up something from prototype to mass production. Usually a Performance or Process Qualification protocol will need to be completed to prove there is long-term stability and quality built in to the process. Each part needs to have acceptance criteria with upper and lower control limits which determine whether it is considered a failure or not. This is most likely done through various statistical process control methods such as control charts. Different types of products will require a certain tolerance and acceptance criteria based off of its risk profile. Utilization of statistical process control is crucial in preventing defective parts from slipping through the cracks and determining if the process is robust enough to satisfy the customer's demands.
Design transfer involves transferring an approved design into production, which itself requires a far-reaching set of procedures to arrange numerous tasks at the same time. Experience, professional techniques, and careful survey are the keys to a successful change. I think one of the main issues lies in increased customer demands. I believe that contrasts in corporate societies, business styles, quality frameworks, and impression of what constitutes design transfer can add to issues.
Design Transfer is best defined as the processes procedures, and related tasks implemented during medical device design and development to ensure that the device design is correctly translated into production specifications and that the design outputs are verified as suitable. Design Transfer is the process of transferring product design information to Manufacturing for the purposes of manufacturing process.
I agree that status meetings and clear communication can help improve the design transfer process, as well as continuing support after a product launch. However, I believe that in order to minimize the amount of time spent on solving problems after the launching of the product, the design team should have gone through procedures carefully with the manufacturing team during the manufacturing of the prototypes. By being familiar with the manufacturing of the prototypes and having the design team also go through the process with manufacturing, side by side, when it comes to production of the final product, fewer problems would arise. Thus, I would put emphasis on the manufacturing of the prototypes so that the manufacturers understand the goal of product, and can more easily handle manufacturing of the final product. Also, it may be helpful to have several prototypes, with the last one being very similar to that of the final product, in order to make the manufacturing process run a bit smoother.