Do Medical Devices Need 802.11n?
Because it promises throughput as much as 10 times greater than that available with current Wi-Fi® standards, the forthcoming IEEE 802.11n standard is generating tremendous interest among users of wireless LAN (WLAN) products. 802.11n throughput rivals that of Ethernet, and so availability of 802.11n may cause some organizations to use WLANs as the primary means of network access for typical computer users.
Although the 802.11n standard will not be finalized and ratified until 2009, it is easy to find laptops, home routers, and other products with radios that are based on a draft of the standard. The Wi-Fi Alliance, an industry association, is performing product interoperability testing and certification based on the draft standard. Should makers of medical devices be racing to add 802.11n to their devices?
Mindray Acquires Datascope Patient Monitoring
Today Chinese medical device manufacturer Mindray announced that they reached agreement with Datascope to acquire Datascope’s patient monitoring business (PMB). The acquisition will launch Mindray into the ranks of leading international medical device vendors and create the third-largest player in the global patient monitoring device industry.
Mindray is paying Datascope $202 million cash, plus Datascope retains approximately $38 million of receivables generated by the patient monitoring business for a total of $250 million (I’m not sure about that extra $10 million, but these are Mindray’s numbers). The Datascope PMB did $161.3 million in sales in 2007. Mindray expects around $30 million of run-rate synergies in manufacturing, SG&A and R&D within 3 years. Mindray has rights to the Datascope brand until 2015.
Cisco CCX and Medical Devices
When it connects to a wireless LAN, a medical device uses the Wi-Fi® radio to send data to and from network infrastructure such as access points. If the medical device’s Wi-Fi connection is unreliable, then the device’s operation will become unreliable, and users will be reluctant to use the device. In some hospitals, network-ready medical devices sit unused in closets because users could not rely on the devices to maintain consistent network connections, especially when the devices were mobile.
Wi-Fi radios adhere to a set of IEEE and industry standards that define how the radio interoperates with a wireless LAN infrastructure. Devices that bear the Wi-Fi CERTIFIED™ seal have passed a set of interoperability tests defined by an industry association called the Wi-Fi Alliance®. A medical device that is Wi-Fi CERTIFIED should interoperate with any wireless LAN infrastructure, but there are no guarantees that operation will be flawless or that connections will be reliable. That’s because Wi-Fi interoperability testing uses access points (APs) from only a few vendors and doesn’t include such things as roaming from one AP to another.
What Is CCX?
Riegel v. Medtronic
On February 20, 2008 the Supreme Court ruled on Riegel v. Medtronic. The patient Charles Riegel and his wife brought the suit after Riegel was injured by a Medtronic balloon catheter during an angioplasty procedure in 1996. The ruling is a clear loss for the tort bar wishing to bring suit for negligent or inadequately labeled PMA devices. More background from the SCOTUS BLOG:
The Riegels’ claims alleged that the catheter had been negligently designed, labeled, and manufactured, that Medtronic was strictly liable for Riegel’s injuries, and that the company had breached express and implied warranties.
Medtronic moved for summary judgment, arguing (inter alia) that the Riegels’ claims were preempted because the Food and Drug Administration (FDA) had approved the catheter pursuant to its premarket approval (PMA) process. The PMA process is codified in the 1976 Medical Device Amendments (MDA), 21 U.S.C. § 360c et seq., to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., which substantially broadened the FDA’s authority to regulate medical devices. The specific provision at issue, 21 U.S.C. § 360k(a), provides, with respect to medical devices, that no state may establish any “requirement” that is “different from” or “in addition to” any federal requirement, or “which relates to safety or effectiveness of the device” included in a requirement applicable under the MDA[.]
Connectivity – The Book
Last October I was asked if I’d ever written a book. The answer was, and remains, that I have not. But then I’m not aware of any else having written a book on medical connectivity. After some thought, it seems that the market may be ready for such a literary epic. (I’m going to have to start wearing turtlenecks or ascots and smoking a pipe.)
The past few weeks I’ve been talking to people asking about publishers and such. I’ve got a few leads, but if you can suggest anyone to contact please let me know.
Here’s what I’ve been able to noodle out:
