Design is a funny word. Some people think design means how it looks. But of course, if you dig deeper, it’s really how it works.- Steve Jobs As the quote goes, when designing a product such as a medical device, you might ponder on some intriguing questions: • Does my product function in a way…
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In the recent years healthcare has significantly advanced with the development of mobile based medical apps. Such apps have facilitated communication amongst doctors, hospitals, medical insurance companies and patients. Medical devices, once restricted to a hospital or clinic, are now evolving to interface with these apps. In women’s health, a woman’s smartphone and her medical…
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Have you ever wondered if the cheese you eat is pasteurized? With increasing consumer awareness, a modern consumer demands to be informed of dairy products that have not been subjected to pasteurization. Consequently, we thought to discuss the safety concerns of raw milk cheese. Milk forms an integral part of American Diet. The total milk…
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The incessant growth in innovation and novel technologies has made the medical device industry the largest in healthcare. The US medical device industry is the global leader with sales of around $136 billion representing approximately 45% of the global market, followed by Europe and China. For pursuing innovation and R&D, companies and entrepreneurs require funding,…
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Are you a Medical Device Manufacturer? an employee of a medical device company? Or perhaps someone with an interest in Medical Devices. If yes, then postmarket surveillance is something critical for you to know. It is a well-known fact that Medical Device manufacturing is a highly cumbersome process; all your efforts pay back when your…
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Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena of manufacturing physical objects, activities are reasonably predictable and tasks are repetitive, whereas, in product development, tasks are unique, the project needs constantly change, and the output with respect to the widespread use…
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While reusable devices significantly help in cost-cutting and optimization of hospital supplies; cross-contamination is a prevalent problem with these devices. Regulatory bodies across the world are taking initiatives to address this issue and hence promote patient safety. FDA posted a press release on April 12th, 2019 which states that the FDA is continuously monitoring the…
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The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally marketed predicate devices. It is one of the least used pathways by medical device manufacturers when bringing a product to market because of the associated data requirements,…
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While the preamendment devices can serve as excellent predicate devices, there are practical challenges associated while using such devices for approvals. One such example is that of a surgical mesh. The U.S. Food and Drug Administration (FDA) on April 16, 2019, ordered the manufacturers of surgical mesh, indicated for the transvaginal repair of pelvic organ…
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Diagnosis plays a vital role in curing a disease. If the diagnosis itself is wrong, the disease cannot be treated. Osteosarcoma, a dangerous but common form of bone cancer which mostly affects the population of children and young adults (15 – 24), is often being misdiagnosed as growing pains or muscle strains, according to the…
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Background
Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 10 years of overall experience where 6 years were spent by Amit in core medical device troubleshooting and compliance, Amit is able to adopt a very pragmatic approach when helping Clients with testing and compliance issues. Amit is a dedicated professional with attention to details. He has helped successfully navigate many Clients through various stages of regulatory approvals.
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Background
An executive with 15+ years of global, medical and research experience. Demonstrated successes through NIH grant acquisition, board certification, launch campaigns, and executive leadership. Proven industry experience across multiple therapeutic areas (Oncology, Psychiatry, Neurology, etc): Medical Affairs (MA) operations – Medical Education & Writing – Clinical research (P1-4) – Regulatory Affairs – Strategy – leadership –organizational development. Medical Affairs management experience has continually been enhanced from developing new departments to assisting well-established ones for companies with annual revenues of $10M to multi-billion. A natural leader that leverages innate and trained communication skills to effectively coach staff, build talent, develop robust teams, minimize conflict, and drive projects to successful completion with a sense of purpose and attention to detail.
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Background
Mr. Vivek Goyal is an IIT Electrical Engineering and Stanford GSB alumni. He is highly passionate about creating successful businesses, helping companies optimally position themselves and their value proposition, and solving various complex technological problems through advanced software methodologies.
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Background
Ms. Parul is a Biomedical Engineer by profession with more than 15 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.
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