I agree that in certain instances, it could benefit the company to outsource the design transfer. For one thing, it is more cost effective. If the vendor follows all the specifications and is trained well than effective design transfer can lower material and production costs, decrease product time to market, increase product quality, and generate customer enthusiasm. However, on the other hand as stated in the article, failure to transfer a design effectively can lead to situations in which specified parts are either unavailable or higher in cost than expected, production workflow is interrupted, and product quality suffers.

I would recommend that a smaller company conduct the design transfer in house, because a failed transfer could be devastating.

I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that are producing many products that can justify and afford the facilities, equipment, personnel, expertise, etc. for in-house manufacturing.

However, because of that, smaller companies must have adept technical or design transfer professionals that not only manage the CMOs well, but also have the insight to know what can go wrong so as to prevent it. This can be a major con for outsourcing, especially since not all CMOs are of top quality.

I have to agree with you on this part a lot of smaller companies do hire separate companies to be able to manufacture their device since for them it cost efficient, if they try to do it for themselves that mean they need to spend a lot more money and since is a small company their profit would probably will not be enough if the small company trying to manufacture different types of medical device. In addition, I’m not too sure what you mean that not all the CMOs are on of top quality.

Actually, lots of larger companies also outsource certain products (or parts of products). For example, say a larger company designs a product and one of the components is patented and owned by another company. Here, the large company cannot make the component due to copyright laws and will not be able to complete the final product. So, they make a deal with the other company so the large company can use their component, or allow the other company to produce the final product and split the profits. Either way, the larger company is outsourcing some of the manufacturing process.

When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is nothing left to chance anymore and the company has made sure their instructions are very clear to the vendor. In this case the vendor has to ensure that they are doing everything to the standard of the company. If the vendor is not able to produce a high quality of work, the company could potentially pull away from them. No matter if a company is small or large, outsourcing will always be done. Once they develop their product, they may want to transfer it to allow for room for other projects to be worked on.

There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or if you have the expertize and setup to do the job in-house. Additional when company decides that it's going to outsource a product in development, a lot of time the manufacturer are involved in the design process from the beginning and helps with prototyping for verification and validation.
In cases where the manufacturers are not involved until after the validation process, this will increase the chance of failure during the design transfer.

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house. Expand internal engineering capabilities helps to use the other company’s full time staff to work on the necessities for this design transfer to manufacturing and reduces the payment for excess labor. In addition, working with the external team to set and manage project timelines, it helps to control project cost, and reduce the time to market. Along with sharing the information with external manufacturing, there are ways to protect the intellectual property rights and still allow the company keep its competitive edge.
http://www.mddionline.com/article/10-reasons-outsource-design-and-development

I also agree that it is in a small company's best interest to utilize outsourced manufacturing. This is mainly because, for a growing company that does not have the resources yet, they cannot afford to have slip-ups anywhere along the production path. In order to mitigate the risks of encountering manufacturing issues, it is most wise to contract an experienced company that will be trustworthy enough to manufacture the product properly. As a result, documentation becomes that much more important. The small company still cannot afford to make any mistakes and therefore must make sure that all Design Transfer documents are in line. On the other hand, a bigger company has the luxury of manufacturing in-house, and although they incur some potential risks, they have a freedom of adjusting manufacturing protocols more easily than that of a small company that must outsource.

- Saad Ali

Outsourcing is a great way for large companies to save money and time. The risk of outsourcing is making sure the vendors are given a proper procedure for the product. Everything must be completed according the their instructions. If not the company is at risk and will be at lost. In my opinion outsourcing is a pro, many of these large companies do not need to hire full time or part time employees, but hire employees through contracts. Many companies do this because it saves them a lot of money.

I agree with you that larger companies would benefit the outsource the design transfer. The goal is if all specifications are completed efficiently, the companies would save a lot of money and time to do other work. Larger companies have so numerous task to complete, outsourcing their product saves a time to do more project to make more money. I also agree with you that small companies should be conduct their product in house, because there is more risk if the outsource their product. Outsourcing their product means spending more money and training individuals.

There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times they will not have the sufficient equipment available to manufacture their product efficiently. Therefore it ends up being more cost effective to pay another company whom have the available tools to make the manufacturing processes go along with ease. It would be ideal for every company to have the sufficient materials and technology needed to manufacture their product in bulk, however this is unrealistic. There are going to be companies established with the sole purpose and expertise of manufacturing products professionally. Therefore companies whom specialize in research and development or quality assurance are going to be able to produce their product more efficiently if they outsource to these professionals. However you must ensure you provide the company with the proper documents and specific instructions to avoid any miscommunication for this could lead to loss of money and time.

I believe that it heavily depends on the size of the company and what the company is producing. The company I work for is fairly small however the technology we produce is relatively unique. Each project is unique and experience is preferred when doing the scale. As well is it easier for us researchers to communicate small details with the engineers who have already done this in the past. In addition once the first project has been scaled up, I would think it would actually be faster and easier to do the work in house.

I think there are pros and cons to outsourcing and it is dependent on your device and companies. Some companies lack infrastructure, or manpower and have to outsrouce others don't and keep it inhouse. Other companies outsource so they can use their people to move on to other projects. Yet outsourcing itself is difficult. Even after visit have been made and protocols have been written there are still many errors that can occur and they take months to complete. It is not always the cheaper options and it depends on the goals of the companies

Pros to outsourcing the design transfer:
1. Cost effective- saves the company money. Production is cheaper in other continues compared to
2. Low material cost- Company has the opportunity to work with other counties that may sell the raw materials need to complete the project at a significantly low price
Pros to in-house design transfer
1. More jobs – this could provide more jobs for Americans which would, in turn, help our economy
2. Quicker to the market- since everything is being done in-house there is a potential that it can quickly be completed and sent to the market to make profit
Cons to outsourcing the design transfer:
1. Long travel time- depending where the company is outsourcing the production of their product the company must factor in the time it will take to distribute the product to retails so that it can be sold
2. Failure to transfer a design effectively – product isn’t able to be completed up to the standard of the company due to lack of materials, quality assurance, etc..
Cons to in-house design transfer:
1. Not cost effective- production in America is more expensive then outsourcing and the company would have to hire more employees and pay them at least minimum wage to work the production line.
2. Pricier product- since the product cost more money to produce it will be sold for more money in order for the company to make a profit