Over the past twelve months, I have attended multiple conferences and panel discussions relating to Medical Electronic Devices. There are three recurring themes: 1. Healthcare cost is getting out of control and is growing faster than in other comparable industrial countries. What to do? 2. Mobile Apps and Wireless solutions are hot. What does it mean? 3. Safety compliance including FDA 510(k) clearance remains a very important part of the medical electronic device development cycle. Can we speed up the process?

Healthcare Cost

Some would suggest that the healthcare cost growth is a ticking time bomb. In 2009, spending on healthcare in the U.S. reached $2.5 trillion and is expected to reach $2.7 trillion in 2011. Furthermore, the U.S. has the fastest growth rate in healthcare cost when compared to other industrial countries, and there is no slow- ing down. It was forecasted that there would be a shortage of doctors and affordable hospitals. Various healthcare-related consortia suggest using technology to help fight the increase.

One of the emerging trends is the use of remote healthcare to help patients and their caretakers connect, to cut down office visits and hospital stays to save money. (Many names are used to describe this: digital health, telehealth, eHealth etc.) While this is still in its infancy, many developers are offering remote home healthcare solutions. They include digital scale, blood pressure monitors connected via a network to deliver data to the caretakers. Others are offering new innovations to enable doctors to listen to a patient’s heart rhythm from afar as if they were in the same office. MEDS will continue to report on the development of new innovations that aim at cost cutting.

Mobile Apps and Wireless

Recently I saw a presentation about the future of a medical electronic device used in healthcare. A patient was coughing into a cell phone and a doctor from afar was able to receive the digital data and provide the appropriate diagnosis. Science fiction or not, more and more discussions are focusing on how mobile apps can be used in the medical field. West Wireless Health Institute, a non-profit organization based in San Diego, CA, is a strong proponent of using wireless to solve healthcare problems. In addition to education, they also fund R&D in this area. Wireless WiGig Alliance, another non- profit consortium, supports using the 60 GHz wireless signals in rapid sharing of medical information between patients and doctors.

While we are all familiar with the iPad and Android applications, the merging of consumer electronics and medical technologies may yield some very interesting challenges. How would the FDA regulate the mobile apps? The FDA recently published a draft guidance document on mobile apps regulation and is seeking public comments (see below). On the surface, using a familiar interface to manage medical devices seems to be logical. But if you stop and think, you will quickly discover that the end-to-end reliability is most critical. I recently watched a doctor demo an iPhone as a handheld re- mote EKG machine display. Who is responsible if there is a malpractice? Additionally, a smartphone design changes every 18 months, while a medical electronic device takes 5 to 10 years to develop and get FDA clearance before going to market. How do these two technologies work together? The mobile apps may have three updates while the medical electronic device is still going through its clinical trials.

In this issue of MEDS magazine, we have an article that talks about such applications. MEDS will also monitor closely how the FDA will regulate this area in the upcoming months. Another challenge in the mobile and wireless areas is end-to-end security, and it will be interesting to see whether the iPhone, iPad or Android will take the lead.

Safety Compliance (FDA 510(k) Clearance)

A panel discussion concluded that because the mission of the FDA is to protect the public safety, don’t expect the FDA agency to speed up the clearance process because the industry desires shorter time-to-market. Safety compliance is an important process whether it is with the FDA, IEC, UL or others. One thing may help. Seek assistance from experienced designers or safety consultants when de- signing mobile medical devices. With their experience of FDA clear- ance, chances are they will be able to help you avoid unnecessary delays due to missing forms, insufficient data or wrong data entry in the filing process. MEDS will continue to provide updates, compliance information and training to help you with your product devel- opment and, hopefully, speed up your product development cycle.

Stay tuned.

Reference: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm