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Challenges for Medical Device Companies

Challenges for Medical Device Companies

This drastically slows innovation, as hospitals and surgeons may continue to use existing technologies simply because surgeons don’t have the time and opportunity to properly train on newer products.

Traditional off-site training is time-consuming for all parties and costly for medical device companies. More importantly, medical device companies have no idea whether their products are being used properly, leaving them open to lawsuits and recalls. This drastically slows innovation, as hospitals and surgeons may continue to use existing technologies simply because surgeons don’t have the time and opportunity to properly train on newer products. A report from the World Health Organization echoes this sentiment, noting the primary reasons for adverse events with new technologies are the result of improper training and long learning curves. It highlights the important implication of this challenge: preventing medical devices from achieving their “full public health potential.”

The FDA recently announced an action plan to make medical devices safer, with one key part of the plan prioritizing the spur of innovation towards safety. The goal of the plan is to better understand the benefits and risks of medical devices once they are used on more patients by more clinicians. This will ensure not only does it meet the gold standard for coming to market, but continues to meet the standard when it is in the real-world clinical setting.

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