The Healthcare and Enterprise Wireless Experience

Medical Design for Regulatory Compliance

Designing products for regulatory compliance can eliminate surprises! How do you move through this maze? Today I had a great conference call with my old friend of many years, Bill Salzstein. Once we got caught up, we shared ironically same stories about how medical device companies tend to look at the 510(k) process. I can attest to this of what I went through this year,it is how you look at the whole risk mitigation piece in light of the reviewer that can have the ultimate impact on the timeliness of the approval process. Here is the excerpt article that Bill sent to me that is a good read.
Download BillSalzstein

Integra Systems, Inc. Reference Wireless Design Medical Devices - 2005 and now 2011

2005, it was the year that we got involved with www.drager.com and saw the vision of enabling at that time 802.11b patient monitors onto an enterprise network. It is ironic that this this has become pretty much the standard for patient monitoring and infusion device companies (OK, now 802.11g and 802.11a). We wrote all the test plans, brought in an outside integrator, and finally when the rest of the team moved on, we drove it through the regulatory approval process.

Moving forward to 2008 and then 2009, we got contacted by www.smiths.com (In between 2005-2008), the author worked for www.johnsoncontrols.com (set up testing there also), and finally www.commscope.com. Smiths Medical (a division of www.smiths.com) had the MEDFUSION 4000 Syringe Pump that needed to be tested and validated from a wireless perspective, to include both quality of service and security. Integra Systems, Inc. wrote the entire test plan and individual protocols, we used an outside integrator to assist with testing and also consulted internal with regulatory for Q/A. Smiths Medical received the FDA 510k approval on the MEDFUSION 4000 Syringe Pump in 2011.

In 2009, www.soterawireless.com contacted Integra Systems. In a similar fashion, we wrote the test plans and protocols (2010), and they are now awaiting their regulatory approval on the ViSi product. Around this same time we saw the real value of using www.veriwave.com, now www.ixiacom.com for validation and verification testing as as well as post deployment testing. As a result we wrote a business plan surrounding this testing and post deployment testing for a non-profit organization. Several of the large patient monitoring companies are now using www.ixiacom.com for internal testing as well. It is my feeling that WaveDeply will become the "best of process standard" for risk mitigation deployment in light of IEC 80001.

In 2011, Integra Systems, Inc. was contacted by www.carefusion.com as they had a very unique patient monitoring product that needed regulatory approval. At first there was some internal hesitation to conduct any type of testing, but after understanding the process, things moved forward in a rapid fashion. This was a unique case whereby we handled everything from the start to the finish which included internal and external regulatory discussions. The premise of the aforementioned is that we have the depth of experience, vision and strategy that has executed real results. However, the best validation statement is simply from a customer.

Integra Systems, Inc. Re-Cap for 2011

It has been a very interesting year and good in the wireless and healthcare connectivity space. A brief re-cap of activities. 1. Developed test plans and protocols as well as conducted testing for a major medical device company (6B). Addressed questions from the FDA reviewer, internal regulatory, and achieved approval in record time (under 90 days) A major win for the company! 2. Worked with the leading provider of embedded (FIPS-4)security to figure out how to embed their security in mobile medical devices. 3. Currently the SME (subject matter expert), that is working with an angel funded company to figure out the correct radio strategy (in this case ANT),to embed into their medical device (solution). Going to commercialization in 2012. 4. Wrote several white papers that got published on wireless and RFLS technologies. 5. Spoke at leading seminars on wireless, connectivity, and mHealth. 6. Conducted several web based events for manufactures of technology as well as the investment community. 7. Filed patents for M to M (machine to machine). 8. Established partnership with the leading government M to M provider. 9. Developed an initial software and hardware platform for M to M, i.e. industrial marketplace. Interest generated from several of the leading players in industrial automation. 10. Became the SME for a leading government organization for the re-design of wireless voice over IP in a highly secure military and national security environment. 11. Completed the re-design of a wireless voice over IP network in a BSL-4 facility. 12. Finalized partnerships for Android and I-Phone application development. 13. Established partnerships with several integrators for wireless field deployments. 14. Created a technology roadmap and key integration requirements for the largest medical device conglomerate. Helped them figure out the remote connectivity and GSM strategy. 15. Worked with venture funded infusion device company to help them formulate the correct wireless, integration, and field deployment guidelines. 16. In process of developing the correct industry guidelines for medical device wireless and wired testing. 17. In the process of working with the leading technology provider of distributed antenna systems to develop generation 2.0 of digial DAS for the healthcare vertical. 18. Consulted with a major league baseball team and one of the largest IDN (integrated delivery networks), for the right design, deployment, and business models for distributed antenna systems (DAS).

Distributed Antenna Systems Evolution

Taking some comments from Seth at SOLiD, but will add my own. Definitely, the revolution especially in healthcare is to provide "smart phones" the need for connectivity inside hospitals. That was definite from the mHealth conference in Washington D.C., last week. So you have to take the connectivity and coverage where people are using these devices.
"The good old days of Tower and Power are ending", there will be dramatic growth in femtocells, picocells, and what we have traditionally thought of as DAS. All of the major DAS players are working very hard on the next generation digital and/or IP based solutions, with the whole idea of placing amplifiers close to the end users. These small cell networks (call heterogenous networks, or HET for short), are a coming design where one network extends from the core to the base station to the outdoor DAS to the indoor DAS to the femto cell with seamless hand-offs. Power levels are then stepped down in accordance. SOLid is developing the next generation Digital DAS based upon optical tunable laser technology which can virtually replicate existing fiber 16 to 32 times, support long distances of up to 60km without regeneration or amplification, and eliminate the need for truck rolls and reduce commissioning time to minutes

QualComm and MHealth Summit

While there was a tremendous amount of activity, the one area that really caught my eye was the 2net Platform. I looked at and thought interesting. In 2010 Integra Systems was presented a "business problem"...connect home healthcare infusion devices. We in under 90 days we had solution that looks like this, however it also used Zigbee with an embedded device server to GSM modem, custom faceplate for the device company and also battery operated. In the case of 2net it uses Bluetooth, where we used Zigbee. I also feel ANT could be used, in fact I have the feeling it really does not matter, ANT, Bluetooth, WLAN, it is bridging to the cellular world. We had to have it's own battery as well as provide AC operation as it had to go outside with the patient. I do like what QualComm (now QualComm Life), has done in presenting an "ecosystem", which extends from what this is considered as a Gateway to the cloud. They have provided all the FDA 510k approvals, as this is considered a Class I device. Apparently they also have ironed out the global carrier approval process. As a side this truly is a M to M (Machine to Machine), type of solution. Device companies should consider this, but also understand the "technology" and management services is out there in the industry at large. In closing, felt kind of good that what I did two years ago, has come to fruition large and center with the leader in this space.

www.qualcommlife.com

mHealth Summit Update Day Two

Well this conference has now grown to over 3,500 attendees from last year. This is no longer a one off event, but definitely has gotten traction. A huge presence is noted of QualComm with all of their partners with many other novel applications. What is interesting is the lack of presence of the traditional companies we know at HIMSS, for instance Philips, General Electric, Siemens, Cerner etc. It seems that the innovation from a wireless and mobility side is coming from the novel start up companies that are establishing true business to business relationships. It is interesting to see how the growth and rapid innovation is coming from these companies, of which perhaps the large companies just may not be able to move fast enough. It is felt that this is definite trend. Picture will follow tomorrow.

Integra Systems aids in the selection of the right embedded radio design for a medical device start up

Integra Systems has been working with a angel funded medical device company in the high technology biomedical community in San Diego to help in the right selection of an embedded radio design. The requirements had to be very low cost, very low power (for up to multiple days of service), provide secure transmission of low bandwidth, yet provide a point to point to multi-point network. Zigbee was ruled out because of cost, (product had to be semi-disposable), no need for the Zigbee overhead, and provide an extremely high level of reliability. After months of working with the supplier a real live demo of the first of it's kind application in the world has been completed. More to come in 2012.

MHealth Summit Conference Washington D.C.

Just arrived this afternoon from Baltimore and this seems to be a start of a very good conference. We will email posts over the next couple of days after my panel session tomorrow afternoon. Expectation is around 3,000 attendees.