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Are you designing to meet your customer needs?

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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Virtual Vital Signs—the Invasion of Medical Devices to our Living Rooms

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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Safety Concerns of Raw Milk Cheese

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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Funding Trends – Medical Device Industry

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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Postmarket Surveillance: An inescapable sound of noise

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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Product Development

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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Addressing Duodenoscope contamination – An FDA Initiative

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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Access to De Novo Summaries – A treasure for manufacturers

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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CLIA Database: A Centralized Database of Clinical Tests & Instruments

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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