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Consultants in the Medical Device Industry

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(@as934)
Posts: 78
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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? 

 
Posted : 27/11/2019 8:14 pm
(@mmejia91)
Posts: 40
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While I have never been involved in meetings with outside consultants, I have had supervisors hire senior level physical therapists (PT) affiliated with our organization. I say affiliated as a researcher working with volunteers on one wing of our campus while our "consultants" work as clinicians for active patients on another wing of the campus.  Our study design required a controlled standard of care PT treatment that contrasted with the experimental groups. The addition of an experienced PT that was already familiar with traditional therapy can curate the most appropriate version of standard of care that can easily be compared with the experimental groups using the resources given for the study. I also believe that the additional familiarity of the PT working in the same building allowed them to recommend patients they have previously treated as prospective study subjects that may fit the study inclusion/exclusion criteria and live in the area.

 
Posted : 29/11/2019 10:58 pm
(@shp37njit-edu)
Posts: 30
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While working in industry, I have mostly come across consultants who were specialized in the areas of the project that we were currently working on. For example, a project involving the creation of a dental brushing data acquisition system involved the use of a dental hygienist from one of the leading dental cleaning companies. Another project which involved the research and development of clinical IV disinfection caps required the assistance of a consultant whom specializes in packaging engineering. I have also been exposed to projects which required consultants from the FDA to ensure all of the regulations of the project are in order. I believe consultants are very helpful in any project since they usually have many years of experience and can give a great amount of help to the project and to the company as a whole.

 
Posted : 01/12/2019 5:45 pm
(@traceymraw)
Posts: 81
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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. 

 
Posted : 01/12/2019 7:29 pm
(@christoph)
Posts: 44
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When a company is engaged in building a medical device, the company may not have all the areas of expertise hired as employees. Resource of a domain expert may or may not be required on a long term basis. This why the need for a consultant may arise. Economically, it may even be better to hire an expert.
[Since this could be claimed as an expense. While the labor of an internal employee would not be able to be claimed as an expense.]  Some companies like to write specifications then give them to another company that specializes in implementation to actually produce the device. So everyone from the second company would be considered consultants.

 
Posted : 01/12/2019 9:20 pm
(@darshannayee)
Posts: 40
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I believe that company will involve outside consultants when they don't have anyone who can fulfill the role or a department or when they think they will require professional input by a consultant who has worked on similar device. Also when company thinks that they can finish project with help of consultant and don't need to hire employee with knowledge of what is required for the project.

 
Posted : 01/12/2019 10:32 pm
(@rv395)
Posts: 36
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Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realises to see. Consulting an physician expert in the field will surely increase the chances of obtaining FDA approval and helps the company achieve their targeted road map. And hiring the right physicians as consultants will inevitably increase the speed of decision making. 

 
Posted : 22/11/2020 3:15 pm
(@maniakberk)
Posts: 46
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There are a lot of consultants in the medical device industry. N most basic, they all have a deep understanding of ISO9001 and ISO 13485. Not every medical device consultant can work with every device, though. They usually specialize in a couple of devices&systems(Medical imaging, endoscopic devices, etc.) and everything about their standards, procedures, etc. They usually gain their knowledge of these systems from their work with medical devices in the industry. Eventually, They utilize their understanding of medical device consultants in the field after a couple of years working as Biomedical Engineering Technicians. 

 

 
Posted : 22/11/2020 11:15 pm
(@lechichr)
Posts: 39
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A couple of years ago, I hired a physician to consult on a medical device for a surgical medical device. The device was part of a combination product used in surgeries to control bleeding. The consultant helped to put together descriptions of the use cases for the device. I found it very informative, since he gave us the practical side of what happens in the surgery. He also provided some useful hints on how to modify the device to make it more useful. My advice is to make sure you develop a scope of work for the consultant to make sure they are focused and provide you their expertise in the area you need.

 
Posted : 23/11/2020 12:59 pm
(@mduru)
Posts: 24
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Consultants are generally hired when a company does not have the specific resources for a task/project or the company does not have enough resources to complete task/project on time.

In my previous job we hired the an engineer who had designed the robot we were using in manufacturing. The robot was built nearly 20 years ago and knowledge wasn't passed down enough to repair the robot at the time. So, the consultant trained us and helped us fix the specific issues we were having.

In another instance, we had a large project and a short timeline. There was no way to finish the project on time with the number of engineers we had so we hired consultant engineers to help out.

 
Posted : 28/11/2020 5:28 am
(@shereenmurrah)
Posts: 39
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For a company, an expert or consultant helps reduce the chance of the device being rejected. They provide support for businesses since medical devices are heavily regulated and it’s a long process to have the device on the market. A consultant helps with Optimizing medical device design & development, Advising the best regulatory pathway depending on classification and therapeutic area, Preparing submissions for regulatory approval such as FDA 510(k) etc, Carrying out comprehensive literature searches, Communicating the product to stakeholders via website content, blog articles, and more. This eases and excels the process for many smaller companies who are working on projects. 

 
Posted : 29/11/2020 1:08 am
 pi29
(@patricia)
Posts: 76
Trusted Member
 

The company I work for works mainly with HCT/Ps which are regulated less stringently than medical devices by the FDA. For one particular project, the product was a biologic however this company had not navigated through this regulatory pathway before. The company brought in a consultant to help guide the project team. They decided to train current employees as well on this regulatory path. I am not really sure why they preferred to bring in a temporary consultant instead of hire an employee with experience. I want to say maybe it was cheaper to hire a temporary consultant with many years of experience while training new employees. 

 
Posted : 29/11/2020 4:59 pm
(@jafar)
Posts: 75
Trusted Member
 

I have never been in the medical device industry, but I think that the company contracts with experts as consultants for some period of time in the whole project because the company may unable to offer the experts like (physician or FDA regulations expert) payments for whole project years and the experts can give their advice to the company frequently without suspending their normal job.

 
Posted : 29/11/2020 8:09 pm
(@266)
Posts: 78
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I currently work as a Technical Writer for a company that offers healthcare technology solutions such as biomedical equipment rentals, technology management, as well as technical service for hospitals and medical facilities. Since my company is ISO 13485 certified, we have a lot of technical documentation that must be routinely maintained and updated. My primary job as a technical writer is to create and update this documentation to ensure the company is operating in accordance to ISO requirements. My company has hired temporary consultants to help prepare, facilitate, and conduct internal audits regarding our ISO 13485 certification. Since starting my position as a Technical Writer, I have received many inquiries regarding temporary positions in technical writing.  There are plenty of expanding companies who are seeking temporary writers to create and update standard operating procedures.  

 
Posted : 29/11/2020 11:14 pm
(@jal58)
Posts: 60
Trusted Member
 

Consultants can be extremely beneficial if a company requires advice in a specific field or niche area. I believe the main benefit of hiring a consultant is the lack of need to train this person in said field. In most places, the consultant should be somewhat of an expert in their field. Therefore they are already a great asset to receive advice or offload work onto.

 
Posted : 09/12/2020 7:14 pm
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