Possible topic for Master thesis topic - MDR and QMS

Muhammad Farooq

Starting to get Involved
I am a student of medical systems engineering. It is my desire to pursue a career in the field of medical device regulatory affairs and quality management systems for medical devices. In my quest for choosing a topic for my master's thesis, I am confronted with the problem that it should be a research-based or finding-based topic. So my question is, what should I look for (possible findings related to regulations) in the master's thesis topic if I choose a topic relating to medical device regulation? I would appreciate your suggestions for the topics.

I have connections with start-up companies of medical devices and they can offer me a position for my master's thesis, but it is my responsibility to find some suitable topic for myself.

Thank you.
 

Edward Reesor

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I would love to see the impact of increased regulatory demand on innovation/new product development. As a small business employee for a family owned medical device designer, we often say that the ever-increasing demand for more regulation will soon create a non-viable marketplace. When Canada made the MDSAP program mandatory for every company wishing to sell their products here, I spoke with many manufacturers who withdrew from the marketplace (our relatively small market wasn't worth the expense). We withdrew from the EU due to the costs to maintain the credentials and I suspect that many of the NB's did as well.
 

Tidge

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I am a student of medical systems engineering. It is my desire to pursue a career in the field of medical device regulatory affairs and quality management systems for medical devices. In my quest for choosing a topic for my master's thesis, I am confronted with the problem that it should be a research-based or finding-based topic. So my question is, what should I look for (possible findings related to regulations) in the master's thesis topic if I choose a topic relating to medical device regulation? I would appreciate your suggestions for the topics.

My advice is to
  1. pick a topic with a regulatory driver,
  2. pick a topic that hasn't been 'precisely solved',
  3. pick a topic that has general consensus of 'being important',
  4. pick a topic that manufacturers/teams will be working on.
I suggest "Approaches to satisfying the cybersecurity needs of customers as filtered through a regulatory enforcement perspective."

I don't think cybersecurity has been 'precisely solved' in the regulatory sense, so this will give you the freedom to explore the assorted position papers that have been evolving us to where we are now.
 

Muhammad Farooq

Starting to get Involved
I appreciate your valuable comments @Edward Reesor @Tidge. Would it not also be prudent to make comparisons between FDA and EU MDRs when launching a novel product for a startup?

The comparison could be based on cost, time, technical issues, regulatory aspects, safety, efficacy, etc. Develop an effective model that enables the company to make informed decisions about where to invest.

I am looking for more comparison parameters as well as strategies.
 

Tidge

Trusted Information Resource
The comparison could be based on cost, time, technical issues, regulatory aspects, safety, efficacy, etc. Develop an effective model that enables the company to make informed decisions about where to invest.

I'm going to bow out at this point, mostly because this doesn't sound so much like a master-level investigation as mechanism for fund-raising via self-promotion. Without having an MBA, I'd say the best investment strategies (seeking highest returns) in the medical device space are:
  1. Spend other people's money,
  2. Stay away from regulated industries, or failing that get the part of the industry you are in to be deregulated (ehem, dietary supplements)
 
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