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Consultants in the Medical Device Industry

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jteamer
(@jteamer)
Posts: 51
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Posted by: @as934

While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in regulatory compliance. Companies may hire compliance consultants to audit their systems in order to make sure they are prepared for FDA audits or as the result of an audit that produced findings. What other areas of expertise has a company that you worked for hired consultants for? Or, if you have not worked in the industry, what areas do you think consultants would be useful in? Why might a company hire someone as a consultant rather than a direct employee? 

I currently work in a hospital administration, and the physicians in my division are have asked to be consulted on various projects for various companies based on their specific expertise. Most of the time, they are contracted out to teach about a method that they use in the OR so that the medical device companies can make sure that their product would be advantageous to common practices. Also, sometimes they help them come up with solutions to areas of their product that are lacking. 

 
Posted : 24/06/2021 10:27 pm
k-faulk
(@k-faulk)
Posts: 50
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Posted by: @traceymraw

I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or someone with a specialized skill set, but the company can't guarantee a long term position for those individuals, it would be a good option to hire them as a consultant. 

Hi @traceymraw

I complete agree with you. In my opinion, when a company has a position to fill that no current employee can do they hire consultants.  Also, if the position is a temporary one.  For example, if I have a government contract to make a specific device and I only need a specific position for 3 months out of the 15 month contract, I would hire a consultant. 

 
Posted : 25/06/2021 8:57 pm
jaf22
(@jaf22)
Posts: 83
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Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of culture and understanding for two forces to become one. A consultant group came in to make a plan for the transition and to aid in any questions for us who have two cultures merging into one. Consultant engineers in my previous company were there to supplement areas of engineering that we didn't have as a medium size (albeit smaller than some) companies have. They fill gaps that otherwise would be hard to fill during the review process. 

 
Posted : 22/11/2021 5:50 pm
mmd55
(@mmd55)
Posts: 80
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I, personally, have never worked with consultants in the Medical Device industry. However, I do think consultants can be a very useful tool. One area I think that consultants can be of use, in particular, is the supply chain. Specifically, Consultants can be hired to analyze the efficacy of a medical device supply chain and make suggestions on how to speed up or make the supply chain more effective. 

I think, like in the case of supply chain consultants, consultants are hired opposed to full-time employees because they are experts in optimizing processes and are able to provide an external opinion. Being experts in optimization means that once their job is done, they would no longer be needed for what they work best at, thus a company wouldn't want to hire them directly but would pay top dollar for their knowledge and expertise. Also, being external to the company means they can look from a different, objective perspective on how they can do their work without being subjected to company politics.

Does anyone share any similar/opposing opinions?

 

Thanks,

Matt

 
Posted : 22/11/2021 9:05 pm
Rifath Hasan
(@rifath-hasan)
Posts: 24
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Posted by: @jaf22

Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of culture and understanding for two forces to become one. A consultant group came in to make a plan for the transition and to aid in any questions for us who have two cultures merging into one. Consultant engineers in my previous company were there to supplement areas of engineering that we didn't have as a medium size (albeit smaller than some) companies have. They fill gaps that otherwise would be hard to fill during the review process. 

Though filling up a void position temporarily is an advantage of hiring consultants, there are many other strong benefits of having consultants. Medical device consultants have a wide range of expertise from development through commercialization for the medical device, pharmaceutical, and biotechnical industries. Therefore, medical device consulting companies can help develop phase-appropriate Quality Management Systems (QMS) that comply with up-to-date regulations, guidelines, and standards. They can also help avoid the pitfalls of implementing too much too fast. So, through their reviews and suggestions, it is easier to get approval from FDA and bring products to market.

 
Posted : 28/11/2021 11:14 pm
mcr29
(@mrela13)
Posts: 36
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While working at my company, we had discovered some problems with our injection molding system during a re-validation. While using the same injection molder and the same settings, we were getting a different outcome from the normal plastic pieces we produced. While this was happening, we did not have any employees who where familiar enough with the injection molding process that could fix the issues in a timely manor. Because of this we had an injection molding consultant who was familiar with our fixtures come in and help the engineers on the project narrow down the settings until the molder was making good pieces again. He was very professional and really knew the fixtures and processes very well. He also made a boat load of money for coming in on such short notice.

 
Posted : 10/12/2021 10:31 pm
veron_perez
(@veron_perez)
Posts: 39
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A consultant would be more useful to hire than a direct employee because consultants do not belong to the company, so they are considered a separate workforce. This means that they have had the opportunity to work with other companies and gain experience from others, making them experts in their field. So once they are working for a specific company they can quickly get up to speed and match the pace of others. But there are different instances to hire a consultant over employees. Consultants are better for short term demand and better for new projects, but if a company needs someone for a long term project that can continue for the future, then employees are the way to go.

 
Posted : 01/12/2022 11:04 pm
knm7
 knm7
(@knm7)
Posts: 39
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Having an external consultant is extremely useful especially in the medical field to improve about workflows and procedures within the company. Consultants are helpful in identifying possible risks, mishandlings, and procedural errors that may be occurring, in which the FDA could issue warning letters or attempt to shut the company down if it does not improve. Since the consultants would have a background in the field and are paid to assist the company in identifying an weak areas. I think consultants are extremely beneficial to the industry and can relieve some of the work load by helping produce ideas to assist the employees and managers. 

 
Posted : 02/12/2022 1:34 pm
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