Lessons Learned from the Medical Device IoT Market

Posted in QMS, Medical Device, IOT
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health-iotTechnology experts expect the Internet of Things to be dominated by everyday consumer devices such as refrigerators, clothes washers and other appliances; door locks, thermostats and other home furnishings; watches, eyeglasses and other wearable items; cars; and robots of all kinds.

However, health and life sciences is one of the most compelling, yet unheralded, application areas of IoT technology. In fact, the healthcare industry helped pioneer IoT.

All the way back in 2008, a company called Proteus Digital Health won a U.S. patent for a pill you can swallow with a tiny sensor inside of it. The sensor transmits data about when a patient takes his or her medication, and pairs with a wearable device to inform family members if it's not taken at the right time.  Anyone else old enough out there to remember the 1966 film “Fantastic Voyage” where a tiny submarine was in fact the ‘pill’?  Sometimes fact is stranger than fiction.

 With the increasing use of sensors by medical devices, remote and continuous monitoring of a patient’s health is becoming possible. This network of sensors, actuators and other real time mobile communication devices, referred to as the Internet of Things for Medical Devices (IoT-MD), is poised to revolutionize the healthcare industry.

A connected form of human telematics, healthcare environment promotes the quick flow of information and enables easy access to it. Improved home care facilities and regular health updates to clinicians reduce the chances of redundant or inappropriate care, ensure patient care and safety, and reduce overall costs of care. Connected health solutions can also be used to track lifestyle diseases such as hypertension, diabetes and asthma, which also require continuous monitoring.

Peter Lucas, the COO of Epic Medical Concepts & Innovations (EMCI), a company that translates scientific research into IoT-ready medical devices, believes the IoT market introduces particularly exciting possibilities in the life sciences industry. Within the medical realm, the interconnection of technology is more useful than the highly touted “big data” at identifying trends, improving response times, and locating small problems before they become big problems.  

“The idea that our medical devices can communicate with the lab hardware in which they operate in a meaningful, real-time manner is really exciting,” says Lucas. “It manifests into improving medical outcomes and finding new breakthroughs, especially for EMCI in the area of cognitive neuroscience.”

EMCI’s most recent disruptive medical device technologies include systems that track physical patient records to reduce errors and speed retrieval time, as well as report on the status of biological specimens in a hospital setting. “We envision these IoT systems eventually sitting in hospitals all across the country and having the ability to communicate with each other” says Lucas.

IoT-MD will drastically change the face of healthcare monitoring and treatment outcomes. By providing personalized, optimized and immediate feedback/services, it will promote a better standard of living and provides a timely and cost-effective response to help nations around the world improve patient care. Moreover, recent developments in sensor, internet, cloud, mobility and big data technologies have led to affordable medical devices and connected health programs, vastly increasing the potential of IoT-MD to influence further changes.

But IoT-MD design challenges are complicated by increasingly stringent regulation and compliance requirements. After all, human lives are at stake.

“It's one thing for your microwave to diagnose itself and call a repair tech; it's another thing entirely to have medical information passing from device to device,” says Lucas. “I believe this will be an area that grows quickly, but will result in missteps along the way. I can almost guarantee there will be breaches of patient data, unanticipated consequences, etc. But on the other hand, interconnectivity of this type will also bring about medical innovations that would otherwise never happen.”

A modern design solution that consolidates all compliance information, including a bill of materials (BOM), the design history file (DHF), and the device master record (DMR), into one centralized system is imperative to meet regulatory audits. For medical device companies but a sampling of the popular FDA regulations and product quality business processes include: 21 CFR Part 11, 21 CFR Part 820 and CAPA (corrective action and preventive actions).  While the list is non-exhaustive, these few are mentioned most frequently by our clients.

The IoT-MD industry is defined by a number of high hurdles, such as increasingly stringent compliance standards, that stand in the way of an OEM’s success. But for those who can overcome these challenges there is the promise of high margins…and vast riches.

And true, while compliance challenges are magnified, and risks are more treacherous in the IoT-MD space, the need to adopt disruptive change and switch directions quickly while juggling stringent quality concerns impacts IoT companies of all stripes and translates into higher margins when executed skillfully with a single all-in-one cloud PLM and QMS solution.

Arena provides a comprehensive quality management solution to enable medical device IoT companies answer the rigors of compliance, avoid costly mistakes, and maximize their competitive advantage. Your entire cross-functional team including supply chain partners can see quality actions, participate in resolving issues quickly, and see the quality history.

Our holistic, all-in-one quality management solution is 100% multi-tenant SaaS, cloud-based with a fast, best practices implementation so you gain immediate benefits and peace of mind for regulatory compliance. 

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About the Author

John Papageorge
John Papageorge has worked at some of the biggest names in the high tech industry, launching products and programs for companies, such as Oracle, HP, Cisco, and Microsoft. John's passion ... Read More 

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