ADVANCEMENTS IN “CONNECTED” medical electronic technologies, with their associated commercialization direct-ly to consumers, are revolutionizing the health care industry. Medical electronics can be seen as the next wave of “Connect-ed Commercialization”, with challenges possibly greater than previous waves, as computers saw their fullest potential con-nected to the internet, as did cell phones connected on global networks. Therefore, it is important to understand and resolve challenges in medical electronics in our connected world, to continue to strength-en the entire global healthcare system.
The large global companies in com-puting, cell phones and internet activities, including Facebook, Google, Amazon, and Microsoft, are developing their own medical products and partnering with the medical electronics companies like Abbott, Medtronic and GE. This editorial addresses challenges specific to indi-vidual human lives and impacting a wide range of medical professionals and orga-nizations. Challenges continue to include; electronics reliability, industry regulation and personal privacy, now adding in com-plex issues related to internet security and connectivity performance, which become critical.
To put things in perspective, measur-ing your heartbeat or footsteps on the standalone “wrist-band device” is impres-sive, however, monitoring your EKG on your smartwatch through your smart-phone app, which can be uploaded to the cloud is unbelievable.
Medical electronic devices for health care, including insulin pumps, defibril-lators, CPAP machines, cardiac devices and oxygen tanks are all being monitored remotely. This is valuable information for patients and the medical professionals managing their care plans, without requir-ing the patient to be supervised or report to a medical facility.
It is important to understand and resolve challenges in medical electronics in our connected world, to continue to strengthen the entire global healthcare system.
Surgeons capable of performing robotic minimally-invasive procedures, with a patient in the same operating room, are aware of additional potential risks of per-forming that same procedure on a patient in a different state or country, with the “connected” systems.
Background : IoT / IP – It is important to understand that medical devices and other electronic devices, such as cell phones and watches, that are connected directly to the Internet (IoT / Internet-of-Things), follow the Internet Protocol (IP). Specifically, “IP” is the “communications protocol” used by the internet to control the flow of information, and although common knowledge to most “techies”, needs to be stated none the less. There-fore, every connected device has their own individual “IP Address” and poten-tial of connecting to all other devices (yes, in the world), part of huge global “IoT” network.
Internet Security – This is going beyond just information, with symptom diag-nostics and their treatments potentially impacted when corrupted or hacked, risk-ing the lives of patients, noting significant efforts continuing to be placed into this important area.
Connectivity – With movement toward WiFi, currently Cellular is preferred method of device connectivity. Being much more mobile and designed for multiple users, it does not slow down like WiFi networks when there are too many users logged onto the system.
Regulation – Connected devices are cer-tified to levels of network performance, tested on ability to send and receive data, as well as signal minimums to be con-nected. Called Over-the-Air (OTA) Tests, they involve the FCC and/or CE and mobile network operators.
Reliability – Medical device reliability in the U.S. is governed by the FDA (CDRH) with Classes I, II, and III, increasing in regulation from Class I to Class III. Design related to improved wireless com-munication, device power and miniatur-ization are all challenges.
Privacy – The HIPPA Guideline (Health Insurance Portability and Accountability Act) for personal information, maintained by healthcare and insurance industries, mandates information privacy and protec-tion from fraud and theft, including inter-net related areas.
In summary, unlike stand-alone medi-cal devices, connected medical devices must be; secure on-line/on-network, maintain connectivity, follow connectivity guidelines as well as FDA regulations, all while continuing to maintain privacy of personal information. Overcoming these challenges will continue to be the focus for the brightest minds in the medical and electronics industries as they continue to merge resources in these efforts.
Progress in connected medical devic-es as related to diagnostic capabilities, with equal improvement in therapeutic treatments, bring hope to individuals and challenges to the health care industry. The challenges mentioned were specific to the product, however, there is another set of challenges related to perception, educa-tion and training for both the patients and medical professionals. Commercialization of connected devices, with people (not just patients) attempting to understand new technologies and information, may strain professional resources, as they address the consumer calls and questions.
I am confident the move toward moni-toring and prevention for “maintaining wellness” will continue to improve stan-dards of living, with earlier diagnosis and the advanced therapies improving medi-cal outcomes for infants to senior citizens around the world.
This is an exciting time to be involved in the medical electronics industry. Please join us at the upcoming MEPTEC/SMTA Medical Electronics Symposium on May 21 & 22, 2019 to hear keynotes and speakers discuss new medical device technologies, with break-out sessions addressing materials, reliability, assem-bly, and challenges related to Electronic Medical Devices.