Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to be modified. Testing protocols for specs have to be properly documented and quality control personnel must be properly trained to ensure quality products. Raw material differences also may result if there is a switch in vendors and/or if quality of raw materials is inconsistent. Management issues may arise if manufacturing is being done by a CMO. These are just a few of the issues that could be of concern.

Design transfer is the process in which the device design is translated into production, distribution, and installation specification.
Some of the common problem during Design transfer include
• Product developers do not have a finalized design.
• Manufacturing processes have not been validated, or documented.
• Safety issues
• Unresolved cost
• Delays occur even after all the documentation is approved, because manufacturing must receive, inspect, and finally release parts for production.
• Developers have not created a vendor supply chain based on an approved-vendor list.
• After making a few devices for verification testing, assume you will be ready to build full scale production volumes.

Hi,

I agree with the above discussion, following are the problem during design transfer.
1. The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures.
2.The purchasing department does not have enough time to identify and approve new vendors, verify component specifications, and update the manufacturing planning system.
3.The design transfer process is well understood by both parties, but the inability to plan the transition of a product design into a controlled manufacturing environment results in slow starts and unacceptable delays.
Failure to appreciate these challenges inevitably leads to unnecessary project delays, frustration, and misunderstandings between the developer and manufacturer.

Hi All,

I wanted to elaborate a little on a point that was made about the difficulty of the purchasing department not not having enough time to identify and approve new vendors, as this can be a major difficultly in the design transfer. If an approved vendor can assist with a project, there typically is not an issue. However if a new vendor is needed the approval process, setting up a legal contract, and setting up billing can all be lengthy processes. Simply setting up the legal contract can take months for both sides. Thus this can be a major issue in the design transfer process.

-Andrew Nashed

I agree with the statement that one of the flaws of design transfer occurs when there is an issue in transition of a product design to manufacturing environment. In order to ensure that the design of the medical device can be correctly translated into production specifications, particular care should be taken when the product involves new and unproved manufacturing processes, or established processes which are new to the manufacturer. It may not be possible to determine the adequacy of full-scale manufacturing on the basis of successfully building prototypes or models in a laboratory and testing these prototypes or models.

for instacne, science protocols are subjected to change, there are disputed methods in the scinetific communinty for thr exact protocol of proecdures and expirments being used. Also in business the change is indictive of the accountingmethods used for the design transfer, for instance if the design and schematics of this product is moved to another company who uses a different approach to accounting inventory then this must be adressed. There also goes to the question of manufacuring processes used in design production. The equipment used and the depreciation methods used for the associated equipment.

I agree with most of the challenges mentioned above by my classmates. However I have to point out that the main two challenges(In my opinion) should be safety issues and communication problems between all the departments working on the device. 2 years ago, I did a summer internship that dealt with electric installations throughout multiple parts of the country,some of the coworkers told me a story about how the company that produced the product had some issues in the 1990's when a worker tried to clean a machine while the machine was still working. The final result was that the worker lost his hand due to safety issues.

The second issue is communication. The project manager needs to make sure that all the departments are on the same boat. This means that everyone knows what they have to do. The coworkers that conduct the machinery producing the product should always evaluate it in order to make sure there is nothing wrong with it. How do they know if it is right or not? Well, that information you obtain it by talking to the project manager, meaning be on the same boat because you will either sink together or reach success together.

Hi,

I found a very interesting intro online.
http://www.mddionline.com/article/preparing-successful-design-transfer

Apart from what was discussed, some of other common problems that arise include the following:

-Product developers do not have a finalized design.
-Business managers and technical experts do not grasp the scope of the design transfer effort and underestimate the amount of time and effort required.
-Manufacturing processes have not been developed, documented, or validated.
-Developers have not created a vendor supply chain based on an approved-vendor list.
-Developers bring unresolved cost, reliability, or safety issues to the manufacturer.
-The design transfer process is well understood by both parties, but the inability to plan the transition of a product design into a controlled manufacturing environment results in slow starts and unacceptable delays.
-The purchasing department does not have enough time to identify and approve new vendors, verify component specifications, and update the manufacturing planning system.
-The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures.
-Delays occur even after all the documentation is approved, because manufacturing must receive, inspect, and finally release parts for production.
Failure to appreciate these challenges inevitably leads to unnecessary project delays, frustration, and misunderstandings between the developer and manufacturer. It is a reason some firms have not taken full advantage of the benefits that an outsourcing relationship can provide.

As some have said, I think the biggest issue for design transfer would be communication between the design team and manufacturing teams. There should be a lot of oversight between the two to ensure that the integration is as seamless as possible. For example, if there are changes made to the product in the design team and these changes aren't communicated to the manufacturing team, then integration come time for the transfer is made much more difficult. This places a great emphasis on transparency and communication between departments. Since I don't work in industry, I can only assume that transparency and communication are the keys for a successful transfer.

- Saad Ali

As stated earlier, communication came become a big issue when it comes to design transfer. There should be well developed system to keep track of necessary work activity between team and department members. Well-developed project plan helps in avoiding risk in long run. Design protocol changes should be discussed in details with the whole team for risk management and product analysis. I have experienced few work errors in a company due to miss communication or lake of information discussed. At times the development departments such as manufacturing, clinical, quality are well aware of the technical changes made in the process but to manage the risk even the marketing to business processes also should be informed about the technical changes to help in promotion details.

Now that we were able to identify most of the design transfer challenges, I believe that it will be a good idea to ask ourselves how can we avoid design transfer failures due to the challenges listed above.
One of the tips for a successful design transfer is to:
- Hire more project managers
- Implement a technical solution to manage tasks, workloads and data
- Increase R&D budget to produce more complete prototypes
- Increase staff for planning validation purposes
- Increase operations capacity through added hardware
- Spend more to train current staff
- Invest in a redesign of the current process to become more efficient
All of these points will require the allocation of more money to ensure a successful design transfer. Any comments?

While these are all good points no one has mentioned simply scale up. Everything on the design sale or in R&Dis on a smaller scale and transfer to manufacturing is just difficult. If parts are being machined machines have to be found that can create small parts in duplicates, they need to be well maintained. If the product requires a chemical making sure the exact amount is being added each time just the general scaling up process.
Also neb2 mentioned some good points to successfully transfer a design and one more to be added would be to spend more time early on thinking about how this project can me manufactured efficiently and effectively.

Out of all of the stages that a company’s product goes through, design transfer is the most important. In this stage, the design of the product is introduced to production and requires a full evaluation of the product’s design documentation, methods to production, and components that are chosen. The process must be performed well and there must be verification in regards to the input requirements meeting the process output. When it is done correctly, medical device companies and manufactures can clearly understand and communicate the requirements and deliverables of the entire design transfer process. However, a misunderstanding of the requirements can cause failure in the process because it can lead to substantial rework and delays. The product developers need to be sure to have a finalized design and an understanding of the amount of time that it takes to complete the design transfer process. Effectiveness of the process will be reduced if there are safety issues that are brought up to the manufacturers, delays due to the wait time of the components and procedure being released, and also the delay of manufacturers receiving and inspecting the components for production before ultimately releasing them. In order to avoid failure in the process, the company should increase their budget in order to be able to produce more prototypes or redesigns of the product, and hire more employees and project managers to properly plan the process and manage workloads and necessary tasks.

In my experience, Supplier notification for custom components is extremely important for companies that outsource some of their components. At my company, it is required to send the supplier a notification of the updated specifications and they must sign to accept the changes. I think this contributes to the working relationship with suppliers and helps identify any parameter changes that the supplier cannot support. Additionally, if suppliers are not fully aware of the changes to the components, they can fail to implement the intended changes and ultimately lead to part rejection or the device being made not to specification.