Meeting regulatory standards and acquiring FDA approval is the last major hurdle to overcome before a new medical device can enter the market, serve its intended purpose, and benefit its intended...
Gregory Montalbano
Gregory Montalbano is the Co-Founder and CEO of MIDI Medical Device Development in Smithtown, New York.
April
29th, 2024
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April
15th, 2024
Medical devices entering the market today have many barriers to overcome before being put into use, and for a good reason. The FDA and other governing bodies, as well as the guidance they set forth,...
April
1st, 2024
All products designed for human use must account for the specifics of its users. Everything from physicality to emotional state can influence the success of a product or its failure. This is...
January
18th, 2023
One of healthcare’s largest and most rapidly expanding market segments, point-of-care (POC) and at-home rapid diagnostic testing, has been a hot topic in the medical world since COVID-19 was first...
January
4th, 2023
Point of Care (POC) and at-home rapid diagnostic testing has been an increasingly hot topic in healthcare since COVID-19 proved the necessity and possibility of alternative diagnostic technologies...