Reference Driver: Not Enough

The core software component of a Wi-Fi product is the device driver for the Wi-Fi radio that operates in the device. That driver provides the interface between the device’s operating system and the radio. Intel, Atheros, Broadcom, Marvell, and other silicon providers may be known for making Wi-Fi chips out of silicon, but they employ teams of software engineers that develop device drivers for APs, routers, laptops, and other devices that use the radios with those chips inside.

While drivers from silicon providers (often called reference drivers) are sufficient for mainstream client devices such as laptops, they are not designed for mobile medical devices. For starters, a driver may not run on a medical device because the driver was written for a different operating system than the one that runs on the device. Even when it runs on a mobile medical device, a driver may not address the requirements of that device, especially requirements for reliable connectivity when the device is in motion. (more…)

Besides patient safety, patient context also greatly impacts medical device workflow. (Medical device connectivity is workflow automation through the integration of medical devices and information systems.) How a vendor implements patient context can have a big impact on usability and customer acceptance.

Patient context requirements can vary, based on the type of medical device in question. What is not variable is the requirement to reliably establish and maintain context. Mobile applications (like smart pumps or patient monitoring) where the device may go in and out of network coverage while constantly in use present special challenges. This compares to a fixed or portable medical device, like a dialysis machine or diagnostic ultrasound, with an episodic use case during which neither the device or patient is moved. Another variable is whether the application is life-critical. Continuous patient monitoring and many alarms (e.g., smart pumps and ventilators) are life-critical applications with a higher threshold of requirements. This contrasts with connectivity for documentation like with point of care testing or spot vital signs capture. In all cases though, patient context must be safe and reliable. The above issues just help define how many hoops you have to jump through to be safe and reliable. (more…)

Obligatory chest thumping:

“This acquisition brings together two leaders in healthcare IT — Hospira has led the industry in barcoding medications and infusion technology; and St. Clair, through Sculptor, was the first hospital in the country to combine barcoding and RFID in a single mobile device for the real-time workflow needs of clinical staff,” said Richard Schaeffer, vice president and chief information officer, St. Clair Hospital.

Note the emphasis on workflow. Given the greater experience of Sculptor, this may end up being a better acquisition for Hospira than CareFusion was for Cardinal. (more…)

The barrier to effectively applying the intuitively obvious to connectivity results from fundamental differences between embedded system devices (i.e., conventional stand alone medical instruments) and the methods and technologies used for connectivity (i.e., general purpose computing technologies). This dichotomy in the application of the different technologies used in both embedded systems and connectivity, extends from product design to regulatory, manufacturing, marketing, sales, installation, service and support. For the vendor, the entire business delivery system is affected. Provider processes - needs assessment, vendor selection, implementation and ongoing internal support - are impacted as well by these differences.

So how are embedded systems different from connectivity? Embedded systems embody the following concepts: (more…)

A lot has changed in almost 30 years - I mean besides feeling older.

The nirvana that was the 1970s came to an abrupt end on February 27, 1998 at 2:17 pm, when, “WFAA-TV channel 8 television began broadcasting on digital TV channel 9 and continued until 10:35 p.m., shutting down transmission a few times to allow a tower crew to work on the antenna.” This and subsequent tests of digital television broadcasts by the Dallas broadcaster, knocked Baylor University Medical Center’s (BUMC) telemetry off the air. Fallout from this intentional (and completely legal) interference resulted in the creation of the new WMTS frequencies for use by telemetry monitors. Between that fateful day in 1998 and 2006, BUMC has spent $6.6 million shifting frequency and upgrading the telemetry systems at their hospitals. (You can read about BUMC’s ordeal reprinted from the AAMI publication Biomedical Instrumentaiton and Technology Journal story on this FDA web page.) (more…)

You can place two seemingly identical medical devices side by side, with the only visible difference being that one has an Ethernet connector and the other does not. That “small” change makes a world of difference when it comes to selling these two devices. Here’s my list of the areas where adding connectivity to a medical device changes almost everything:

• Required new knowledge
• Qualifying prospects
• Dealing with new decision makers (typically with veto power)
• Selling a solution, rather than selling the box
• Selling one-off systems, rather than cookie cutter widgets
• Aligning incentives
• Making it work, getting paid
• Keeping the customer happy, keeping the system working
• Customers want a whole product solution

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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?

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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.

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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?
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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[.]

(more…)

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