Many things have changed at Cisco since they were visited by the FDA in 2006. Awhile back Kent Gray, global lead for Healthcare Solutions at Cisco, explained to me that the FDA was responding to a brochure produced by Cisco that included a photo of a 7921 handset displaying a patient monitor alarm and associated waveform. The FDA observed that the photo represented labeling of a Class III medical device for which Cisco did not have regulatory approval. Thus began a crash course in the health care school of hard knocks for Cisco.
To Cisco's credit they have since made many substantive changes to their traditional approach to vertical market marketing in response to the special requirements of health care. During the AAMI conference this week in San Jose, I had a chance to meet with Erik Petersen, the Global Healthcare Solutions & Technology Partnerships Manager, to talk about what Cisco's been doing in health care.
Health care has strategic importance to Cisco. After their run in with the FDA - a rite of passage for health care vendors - Cisco's commitment to the market was confirmed by no less than CEO John Chambers.
As a corporation that has experienced enviable growth, the company is grappling with the transition from a $40 billion company to one doing $60 billion. "Cisco wants to offer a strong proactive value proposition in health care," said Petersen, "rather than just providing a piece of infrastructure that the customer has to deal with for an overall project." To meet their growth objectives, the company is shifting from a horizontal market company to one focused on vertical markets and applications. To us in health care, this means responding to the unique requirements of our vertical market.
Cisco - Registered Medical Device Vendor
In the past couple years, Cisco has established a health care regulatory affairs group and hired experienced regulatory folks. Cisco has registered with the FDA as a medical device vendor and has been audited by the FDA twice since this registration. More surprising, Cisco has submitted the 7921 wireless handset as a Class I medical device for use with nurse call systems, laboratory information systems, building alarms, and two imaging filings (here and here).
To this observer, embracing the unique requirements of the health care market is exactly what horizontal vendors must do - if they don't want to become marginalized as technology continues to get closer to the point of care. With recent pronouncements by the FDA, regulatory requirements are clearly moving in this direction. I'm not aware of any other big infrastructure vendor (other network vendors, Microsoft, Dell or HP) who has stepped up like Cisco.
Time will tell how effectively Cisco can leverage this encouraging change into meaningful (and competitive) solutions to some of health care's hardest problems. Early signs of this change can be seen in Cisco's in-depth validation of health care applications.
Cisco Validated Designs
The CVD program takes specific applications (from one or more technology partners) and provides a validated reference design or implementation of the solution. To date, Cisco has validated two health care applications, the Imatis messaging system and Acuo Technologies DICOM Services Grid software. After presenting a description of the application and its architecture, CVD documents dig into design requirements specific to the application. For example, in the Imatis messaging CVD, design requirements for quality of service, high availability and wireless network are tested, validated and documented. The final product is a detailed implementation guide for resellers, systems integrators and customers. There is real value to validating a specific design and ensuring that important requirements are met.
Another CVD effort centers around integrating medical devices to Cisco networks. Cisco is presently developing a program, called AssureWave, that will result in validated network designs. AssureWave will emphasize redundancy, failover, resilience, and wireless performance for life-critical applications. The first group of vendors to go through this program include GE Healthcare, Philips, Draeger, and Welch Allyn.
The CVD process takes Cisco and the solution vendors months to complete, and must be updated when new releases of the products in the design become available. A similar program, Solution Reference Network Designs, provides detailed design documentation for specific applications like (all links to pdf documents) a High Availability Design Guide, Enterprise QoS Solution Reference Network Design Guide, Wi-Fi Location-Based Services Design Guide, and various documents on security and mobility (roaming across access points and subnets). The upcoming international standard for networked medical devices, IEC 80001, would make a great topic for a future Cisco reference document of some kind.
Managing this next stage of growth is a big challenge for Cisco. They are not the nimble company they were $30 billion ago, nor can they simply extend their considerable acquisition prowess into deeper vertical market support. Cisco will have to build industry business units with deep vertical market knowledge and tight integration into Cisco R&D to create network gear and applications that meet market requirements. It sounds like Cisco is moving in the right direction.
There is also a role in all this for providers. There are many hospitals world wide pushing the boundaries of technology in an effort to reduce costs and improve patient safety and outcomes. Providers can contribute by documenting requirements and facilitating vendor communications. Recently Rick Hampton at Partners HealthCare brought together a group of vendors to work through some problems with wireless medical devices on their Cisco network . These meetings have resulted in the first AssureWave project involving medical devices. Hampton's efforts should eventually benefit both Partners and the health care industry as a whole. More hospitals need to step up like Partners, and bring vendors together to resolve connectivity and integration issues.
UPDATE: I have added links to Cisco's filings in the FDA Registration and Listing database.