Dev Doshi | Medical Device Courses

Dev Doshi posted a new topic "Consumer Input in Marketing Outputs" – 1 week, 4 days ago

This week’s lecture discusses the mission statement for a company and how the marketing in medical devices must align with this statement across departments. What stood out to me was how marketing is often treated as a separate entity from… Read more»

Dev Doshi replied to the topic "Company Mission Statement" – 1 week, 4 days ago

If I were to create a company, it would be a physician-led medical technology company. I would be the physician, and this company would design and create evidence-based devices directly from clinical experience. I would close the gap between engineering… Read more»

Dev Doshi replied to the topic "Medical Device Marketing: Informative or Misleading?" – 1 week, 4 days ago

Hi @atmeh-njit! Excellent post and question. I totally agree that marketing is essential, but also very risky in the medical device field. Marketing is so that the buyers want the product and understand why they should want it. This is… Read more»

Dev Doshi posted a new topic "Evaluating Medical Device Projects (ROI, NPV, Value)" – 2 weeks, 3 days ago

Understanding how to measure success is extremely important to run a successful business, especially with medical device development. Return on Investment and Net Present Value are tangible measurements to evaluate whether a project is worth pursuing. They quantify risk and… Read more»

Dev Doshi posted a new topic "Starting a Business as a Physician" – 2 weeks, 3 days ago

I know many people who want to become physicians and eventually open their own practice in whatever specialty they choose, since it gives them more freedom than a hospital job. It also allows them to take a lot of profit… Read more»

Dev Doshi posted a new topic "The Corporate Veil" – 2 weeks, 3 days ago

Dr. Simon discusses the corporate veil in his lectures. The corporate veil is the legal protection that the owners of a company get. In a sole proprietorship, someone’s personal assets are in danger if the business fails. Corporations limit this… Read more»

Dev Doshi replied to the topic "Sole Proprietorship or Partnership?" – 2 weeks, 3 days ago

Thanks for the scenario! I agree with Krish, I would do a Limited Liability Company (LLC) that would likely be taxed as an S-Corp instead of a sole proprietorship or general partnership. In Dr. Simon’s lecture, he talked about how… Read more»

Dev Doshi posted a new topic "Audit Culture" – 2 weeks, 5 days ago

Dr. Simon’s whiteboard explanation this week showed how every subsystem (design controls, purchasing, risk management, training) is a process that is a part of a larger process. Each has inputs, outputs, and feedback loops that make it so that problems… Read more»

Dev Doshi posted a new topic "Quality Control & Quality Assurance Communication" – 2 weeks, 5 days ago

Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Control executes the rules, measures results, and sees whether products… Read more»

Dev Doshi posted a new topic "Unified Quality System?" – 2 weeks, 5 days ago

In Dr. Simon’s lecture, he clearly linked the quality system hierarchy back to management. Quality starts at the top, where management defines the mission statement, leading to the quality policy. This drives the quality manual, work instructions, and procedures. I… Read more»

Dev Doshi replied to the topic "Who Should Be Responsible for Regulatory Basics?" – 3 weeks, 6 days ago

I agree with everyone’s response regarding the need for engineers to understand the regulatory basics in order to create products that don’t need revision early on in the design process, since they can avoid potential roadblocks before they even happen…. Read more»

Dev Doshi replied to the topic "Graph of the Timeline of EUDAMED Registrations" – 3 weeks, 6 days ago

EUDAMED is a big step towards transparency with medical devices. Even after a year from the last post in this forum, EUDAMED is still not fully operational or mandatory. It was originally set to become mandatory in May 2020, but… Read more»

Dev Doshi replied to the topic "Are Regulations Helping Innovation or Slowing It Down?" – 3 weeks, 6 days ago

@jacobchabuel I think you give great points regarding safety and how the public would view a device if it were not tested beforehand. To answer your question, I think the FDA should create a program that will financially support smaller… Read more»

Dev Doshi replied to the topic "Should Companies Use Safer Materials or Take Risks With New Ones?" – 1 month ago

I think pushing forward with development is crucial for any kind of research and innovation. However, a balance between safety and innovation must be found. Pre-clinical research exists for a reason, and this pre-clinical research can allow for new materials… Read more»

Dev Doshi replied to the topic "When researching, are you Academia or Industry?" – 1 month ago

@danieshat1 I think the profession of a physician can combine both academia and industry research. A doctor can conduct research and clinical trials for different medical devices if they partner with a company, or they can do research purely for… Read more»

Dev Doshi replied to the topic "What Is the Biggest Challenge in Pre-clinical Device Development?" – 1 month ago

I agree with how difficult the organizational and approval process is extremely time-consuming since, as stated in the lectures, lawyers take months to sign contracts, and things don’t always go as planned. However, I think doing the actual research is… Read more»

Dev Doshi replied to the topic "Project Management Strategies in Academia" – 1 month, 1 week ago

@vthampi Hi vthampi, I agree with your points regarding the ambiguity of academia and how many tasks may take much longer than expected. With academia, usually Murphy’s Law applies, and the results that you were expecting end up being completely… Read more»

Dev Doshi replied to the topic "Prioritizing tasks while managing multiple projects simultaneously" – 1 month, 1 week ago

I agree that having a timeline is crucial to managing multiple projects; however, something that the previous two responses mentioned but did not expand on is the importance of communication in managing multiple projects as well. To prioritize, you must… Read more»

Dev Doshi replied to the topic "Project Management and Artificial Intelligence" – 1 month, 2 weeks ago

Most of the replies in this thread are from 2023, and I find it very interesting to see the thought processes of these times. I agree with what previous replies have said, where humans need to use AI to their… Read more»

Dev Doshi replied to the topic "Academia or Industry Preference?" – 1 month, 2 weeks ago

@ag2357 Hi, I feel the same way about academic research as well. I have joined many labs to hopefully get my name on publications, but a lot of the work I do is usually for grant writing. Even though I… Read more»

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