If I am running a company, I would prefer to outsource the design transfer to lower the labor costs, real estates and plant costs, fewer regulations and much more. With that, as a precaution, I would also first send a small batch to be produced and make sure it meets the company standards.
Whenever production of a product needs to be exported, there are several production issues to look out for. When exporting the production design, it is integral to have strict, concise, and clear instructions for the other company. Also there needs to be a channel of clear communication between both companies for rapid communication in case of emergencies. Also the cost of production will be somewhat larger when outsourcing the production of the item. Additionally, transportation of the material needs to be accounted for and taken into account when calculating the cost of outsourcing. If there any mishaps or mistakes in the product, it can be costly to go back to the company and ask them to reproduce the product.
There a number of general financial reasons why a company may choose to outsource a portion of a business. Generally, these tend to depend on cash flow and the growth avenues a company chooses to focus on. When facing a cash flow issues, it is generally wiser to outsource a business segment. Despite outsourcing being more expensive, it requires significantly lower upfront investment costs. Even when cash flow is not a significant issue, a company may choose to use its resources to engage in growth in a different segment than the one being outsourced. This can often be a wise decision.
Of course, as Akash mentioned, outsourcing a design, it is essential that communication is very clear, and that costs, transportation, and manufacturing design well communicated and accounted for.
While I agree that outsourcing can be a cost-effective and overall wise move for a company, there are also a few drawbacks to consider. Primarily, outsourcing adds another step to bringing the product to market. Transfer between the company and the location that the work is being outsourced to will cost additional time and money, which could offset the money saved in production and the convenience of having a smoother cash flow. Furthermore, even with proper communication, there is still difficulty in ensuring that the product is transferred properly and that the same level of quality is produced as it would be in-house. Finally, by outsourcing the product, the company's involvement in the creation of the product is displaced. In a managerial point of view, it is typically more difficult to motivate workers when their workers cannot identify with the mission of the company. This becomes relevant for the workers in the company that the work is being outsourced to, and to the workers who will receive the product after the previous work has been outsourced.
I will say the coin has two sides to it so in the same way the outsourcing also has its own advantages and disadvantages, In this case particularly I will say outsourcing is the best option because:-
1- Most of the times tasks are outsourced to vendors who specialize in their field. The outsourced vendors also have specific equipment and technical expertise. And Effectively the tasks can be completed faster and with better quality output.
2- Outsourcing the supporting processes gives the organization more time to strengthen their core business process.
Their also a disadvantage in outsourcing that a vendor may be catering to the expertise-needs of multiple organizations at a time. In such situations vendors may lack complete focus on your organization’s tasks. And off course their is a big risk of exposing confidential project data to an outsourcing company.
Most of the point are covered in the discussion above but I would like to add some more points to it.
Cost And Efficiency Savings.
Reduced Overhead.
Operational Control.
Staffing Flexibility.
Continuity & Risk Management.
Develop Internal Staff.
Disadvantages:
Possible loss of control over a company's business processes
Problems related to quality and turnaround time
Sluggish response times coupled with slow issue resolutions
Shortcomings in performance vis-a-vis expectations
Lower than expected realization of benefits and results
Issues pertaining to lingual accent variation
An irate customer base coupled with enraged employee unions
In terms of outsourcing the production of a biomedical device, I believe the type of product being made has a major influence on whether this could pose potential pros and cons. For example, if the product is something simple like a wearable watch to calculate heart rate, then it may be beneficial to outsource its production. On the contrary, it may not be feasible to outsource a product such as an implant. The reason for this is that during the production of the implant unwanted material could make its way onto the surface of the implant. Since the surface properties of an implant play an important role on the acceptance of an implant by the body, it may be more challenging to assure quality standards at an outsourced production facility. As a result, it may be more beneficial to produce such a product in-house or at a facility where the company can better assure that no contaminants are making their way onto the surfaces of their product. Overall the pros and cons of outsourcing the production of a medical device are contingent on the type of product being made.
Pros of outsourcing manufacturing process would be money and knowing your product is being manufactured by a good manufacturing company. Because it would be expensive to manufacture devices in house because you have to buy costly equipment and manufacturing engineer. You also have to follow GMP and keep your manufacturing company up to date with standards. Outsourcing manufacturing avoids theses issues.
Cons of outsourcing would be that you have to travel to the location so often to make sure the company who is manufacturing your products is up to date on standards and follows GMP and not cutting corners in manufacturing your product because peoples life depends on your product.
I would like to point out a crucial point. The manufacturing process or the design transfer success rate will depend on how well the outsourcing manufacturing factory understands the steps before the design transfer phase. In other words, no matter the reputation of the large manufacturing plants if the instructions are not clear the whole product will fail. In addition, it is extremely important to have a person from your company to be in regular contact with the plant threw the manufacturing process to make sure what you intend is what the final result will be. Communication is crucial as well. Outsourcing for manufacturing requires as much as involvement as manufacturing in the house if you would like to increase the chances of success.
I think there are few pros/cons to both the ways, but in my personal opinion outsourcing the manufacturing part to outside contract manufacturer is better. Doing this we get another idea and the work will be done faster as it saves a lot of time if we get this done from a unit which is already in the same kind of manufacturing business, it will save a lot of money as well.
It is important to understand couple of things when it comes to design transfer that is Inability to transfer a design effectively can prompt circumstances in which determined parts are either unavailable or higher in cost than expected, production workflow is interrupted, and product quality suffers. On the other hand, the rewards of effective design transfer are extraordinary: it can bring down material and production costs, decrease product time to market, increase product quality, and generate customer enthusiasm.
Outsourcing the design transfer can be beneficial in many ways, such as cost efficiency or a shorter time to market. However, and possibly bias because I am currently a supplier quality intern at a medical device manufacturing company, I believe the greatest risk in outsourcing comes with ensuring quality of the final product. This will take a lot of process validation testing and inspection controls, as well as established processes that account for non-conforming material reports if final products are not meeting inspection criteria, and such ways to address and correct for this. From my understanding, outsourcing the design transfer is analogous to having a single supplier that manufactures basically your entire product. It would therefore be imperative to have an idea of that "suppliers" ability to fabricate the design, test it, if they have accreditations, or evidence of an effective quality management system. Depending on the risk of the product to the end user or how intricate the design is, traceability and critically of each part within the final product might be necessary. There are many moving parts to this and I presume there are varying methods of effective design controls that have used an outsourced design transfer. Some additional considerations should include the size of the company, what the actual product is, who is distributing/storing/selling these devices etc.
Outsourcing your Device to another manufacturing company, there are a lot to consider before making such a decision. It comes with it's Pros and Cons of doing this.
Choosing the right outsourcing partner or company can pose a challenge unless you have a strong market intelligence to guide your outsourcing decisions. You have to take into consideration the resources the other company is offering. Are they of quality standard to meet your demand for the type of medical device that you would want to produce? Will they require more resources which might not be cost effective and go beyond what was budgeted for the project?
Most times when the right outsource company is chosen to produce your device the advantages of this is that it can Increase the speed of the device to go out on the market, reduce costs if outsourced oversea which most companies do today.
If the wrong outsourcing company is chosen, this can lead to a serious problem of who calls the shots and solely makes decisions on change control if any rises. Also, differences in standards could lead to quality problems, since outsourcing companies mostly care about the profit as to your company who is outsourcing who are motivated by the mission and vision statement that have been laid down.
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.
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.