What courses/background study should I do, to become a Medical Device Consultant?
I am currently employed with a degree in Optical Technology, and have 11 yrs work experience. Of this, I have 6 yrs experience specializing in customer telecom and datacom applications, with optical modules. I want to change career path, to become a medical devices/instrumentation consultant. I want to develop product specs, and consult with doctors/surgeons on requirements for medical monitoring and surgical equipment, then deliver this to engineering. I currently have no medical background. Although I have a strong background in lasers and optics, and most medical equipment now use a laser/optics. Any suggestions are welcome either from people already in this field or others.
I am in the Medical Device industry….started in Engineering, now in Marketing. In general, the two medical device topics that are the most difficult to understand and also the most important are:
1) Regulatory requirements – the product that you are working on may be classified by the FDA from Class I, which include basic products like bandages and syringes, to Class III, which generally are life-sustaining and /or invasive and probably require human-use clinical trials. These distincitions drive everything from the level of control (i.e. documentation, testing and oversight) that you will need over your design and manufacturing processes to the amount of time and money it will take you to get your product to market. www.fda.gov provides a pretty good overview of the requirements.
2) Reimbursement (i.e. Medicare, Medicaid, Private Insurance, etc.) – who will pay, how will they pay, how much will they pay. Everyone has an opinion on the state of medicine in the U.S., particularly with the elections getting warmed up, but rest assured that reimbursement for facilities and practitioners in the U.S. is complex.
In reality, you don’t need to become an absolute expert at either of these topics, but you need to know the basics. Do not assume that medical professionals will understand these things either. Doctors generally don’t need to know what it takes to get a medical device to market and don’t really understand how they are being reimbursed.
Hope this helps!
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