Medical device regulations are complicated and ever-changing. We’re currently experiencing a significant amount of regulatory change. Paper-based quality management systems make it nearly impossible to maintain pace with both regulations and increasing levels of competition.
Meanwhile, technology is rapidly changing the way medical device companies manage their quality systems. There is simply too much at stake to rely on paper. Because of their inherent nature, paper-based quality management systems are disconnected, not transparent, not traceable, siloed, manual and reactive.
Experienced medical device companies understand that they need automation to stay competitive. We’re seeing that even the large medical device companies, who have traditionally clung to paper-based systems, are moving to an eQMS and getting high-quality products to market faster with less risk. Paper-based systems are quickly becoming obsolete.
Co-founder and CEO of Greenlight Guru
In the right hands, healthcare data saves lives by helping doctors track, detect and prevent diseases and illnesses. In the wrong hands, it can result in identity fraud, or even ransoms on patient information. Virtually all the insight needed to steal someone’s identity, bank account or private health history can be found in patient files.
Paper forms require staff to spend up to eight hours per week—one full work day—in outdated workflows. These forms are also prone to lying on desks or in insecure files, leaving the information contained within vulnerable to a wide range of individuals who aren’t authorized to interact with patient data.
The healthcare industry is ripe for a digital transformation, for more efficient employee workflows and increased data security. Healthcare data breaches shouldn’t be the new normal. With proper HIPAA protections and data encryption, efficiency and security don’t have to be mutually exclusive.
CEO of Formstack
Healthcare is an ever-evolving industry when it comes to things like medical technology, surgery techniques and patient services. But one thing that medical service providers seem to be falling behind in is digital transformation. It’s not just trendy tech companies and Fortune 500 companies that have had to make the change, it’s everything from mom-and-pop shops to restaurants and even hospitals.
The healthcare industry deals with very crucial and personal patient details, and having this information in solely a paper-based format is simply not cutting it anymore. The transition to digital is more important now than ever, for the obvious reasons of privacy, immediate access, and tracking, to less obvious reasons like patient satisfaction and billing.
Another opportunity of digital-based medical devices is the patient compliance. For example, Medicare requires that, for some medical device reimbursement scenarios, patients must actually use the device and provide evidence of doing so. With an analog device, it often times required door-to-door in-person checks to physically look at device usage—which is neither time efficient or cost effective. A connected medical device, however, can collect the data as it being used and send it to the cloud to be tracked and analyzed.
COO of Galen Data