Design Transfer - Introduction to Design Controls

RE: Design Transfer

jj52 — Sun, 05 Nov 2023 17:55:58 +0000

There have been lots of good points mentioned on the benefits of outsourcing or stay in house. The main point that was made is if it is cost effective for a company. I think staying in house is always more beneficial because everyone is on one accord on how the designs should be produced because they were created by that specific team. My concern is how can we assure when transferring to a different company that there will be sufficient communication to properly produce devices.

RE: Design Transfer

rm829 — Wed, 01 Nov 2023 12:10:02 +0000

Coming from a company that outsources many of their different drawings, outsourcing is crucial to the manufacturing of medical devices. One of the best benefits is that on a large scale, you can train multiple different companies to be compliant with making whatever component/device you want to produce and this gives you a constant in-flux of product to either put together, test, or whatever is necessary for the components/assemblies. However, what I've seen as well with this is that communication on up-Revs of documentation, or even the errors that certain molds that these suppliers can make can greatly hinder production as well. And with even more outsourcing, comes the greater risk for problems to arise. You need to have constant monitoring of these companies and their performance in order to determine if it's time to go with a different company, prioritize the output of one specific one that has already been successful, or even remove companies that have lost their productivity.

RE: Design Transfer

tgt6 — Mon, 14 Nov 2022 04:45:46 +0000

As others have said in this thread, outsourcing this type of project can have its pros and cons. One of the biggest advantages to this would be the time and resources saved during the transferring process. Many different checks and controls need to be made and having a third party doing that while the rest of the company is working on meeting other goals will be very efficient in the long run. On the other hand, outsourcing the project will have higher financial costs and can provide an added element of risk. When part of a project goes external, as opposed to keeping everything internally, there is a chance that they do not know everything that is going on and can miss some key details. This can lead to information getting misplaced or lost which can be a big detriment to the project overall. On the topic of the financial decision, the company must be able to decide if this is worth the investment or if they are able to handle the process internally.

RE: Design Transfer

ameen — Mon, 14 Nov 2022 01:46:24 +0000

I have to agree with you that a lot of smaller businesses hire separate companies to be able to manufacture their device because it is cost-effective for them to do so. If they tried to do it themselves, however, they would have to spend a lot more money, and since they are a small business, their profit would probably not be enough if they tried to manufacture various types of medical devices. It is also possible to undertake a risk vs. benefit analysis to determine if one should outsource or carry out in-house production. One may run financial risks with in-house production, particularly for smaller businesses that might not have the finest tools for the job. On the other hand, outsourcing could be dangerous because the other company might not fully get your objectives, which could have disastrous effects.

RE: Design Transfer

jafangnibo — Sun, 10 Apr 2022 02:25:07 +0000

I think whether or not outsourcing would be dependent on the companies needs and finances. I think if a company has the funds, by all means they should outsource this kind of work. It can make work more efficient and make time for the company to focus on doing other pressing things. I think this would be similar to how large pharmaceutical companies hire CROs to do their research services for their products. I think a con would be that although you may have given the outsourcing company a protocol to follow for the design transfer process, you cannot directly monitor what they are doing, so the end results may not be to the companies standards or their liking.

RE: Design Transfer

ridmehta — Wed, 03 Nov 2021 03:29:32 +0000

I would have to agree with @cef3 that it is more cost effective for smaller companies to outsource their manufacturing processes. Buying land, constructing facilities, buying equipment, and paying workers to put it all together can be far too expensive of an investment especially for a company trying to get its feet off the ground. Even many large corporations use CMO's to take advantage of their already existing machinery. However it is important to note that although the work may be outsourced, company members will still have to attend the site to ensure the facilities are up to par with the company's expectations. Therefore, expenses may still exist to send these employees back and forth but it is still much more cost effective to do so this way.

RE: Design Transfer

rowel2202 — Fri, 25 Jun 2021 01:00:36 +0000

The advantages of outsourcing the design-to-manufacturing process include utilizing interdisciplinary skills, receiving breakthrough ideas from other sectors and technologies, and being able to expand without having to maintain technology in-house. Expanding internal engineering skills allows the other company's full-time employees to work on the requirements for this design transfer to manufacture, lowering the cost of extra labor. Additionally, working with the external team to define and monitor project schedules aids in cost management and time to market reduction. There are strategies to safeguard intellectual property rights while maintaining the company's competitive advantage, in addition to exchanging knowledge with external companies.

RE: Design Transfer

jal58 — Sun, 01 Nov 2020 22:52:20 +0000

Outsourcing manufacturing is often cost-effective for companies. Cheaper materials and optimized manufacturing processes can lead to cheaper products and faster production. However, outsourcing can also lead to sub-optimal quality inspection. Outsourcing manufacturing will require a more extensive Design Transfer Process. The outsourced manufacture might not have the same inspection procedures that you require. It is important to be very specific on what the inspection entails. So sometimes it might be better to manufacture and inspect products in-house to meet the desired specifications.

RE: Design Transfer

dyc6 — Sun, 01 Nov 2020 14:27:15 +0000

A risk vs. benefit analysis can also be done to decide whether one should outsource or perform in-house production. With in-house production, one may face risks with money, especially for smaller companies which may not have the best equipment to do so. On the other hand, outsourcing may be risky in that the other company may not correctly understand your goals, which could lead to disastrous results. It is important to weigh the risks vs. benefits and understand the type of company you're in and whether it has sufficient facilities or not. It is also important to have back-up plans, as with anything else, so that if outsourcing goes awry, the company may be able to perform in-house production or have alternative companies to outsource with. Therefore, I think both outsourcing and in-house production can be risky, so it is up to the company to analyze their facilities and their current state (new vs. well-established) to decide whether to outsource or not.

RE: Design Transfer

anvitha — Sat, 31 Oct 2020 13:33:46 +0000

The benefits of outsourcing the design transfer into the manufacturing process are leveraging multidisciplinary expertise to have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have sufficient equipment available to manufacture their product efficiently. Therefore it ends up being more cost-effective to pay another company that has the available tools to make the manufacturing processes go along with ease. Larger companies have so numerous tasks to complete, outsourcing their product saves time to do more projects to make more money. However, it is important to ensure to provide the company with the proper documents and specific instructions to avoid any miscommunication for this could lead to loss of money and time.