Medical Device Start Ups and Connectivity
Entrepreneurs are all about commercializing their novel technology, getting to market, driving adoption and realizing an exit strategy. Yet with the incredible focus on transforming their novel technology into something customers can buy, few startups take connectivity requirements into account until too late in the process. The consequences frequently result in revised go-to-market strategies, like going to market without important features or shifting to niche markets with lower connectivity requirements.
Customers Want More than the Box
There are many barriers to entry in health care: regulatory hurdles, entrenched competitors and gatekeepers like group purchasing organizations (GPOs). Increasingly, connectivity is becoming a barrier to entry – or perhaps a new price of admission. There are few medical device product categories that don’t have some connectivity requirements. (More on the actual requirements below.) But besides buying the embedded device, providers are increasingly interested in buying whole product solutions.
IEC 80001 to Impact Providers
In the first installment on the IEC 80001 standard, I delved into the history of this particular standards effort and the patient safety needs the standard is supposed to address. There are two kinds of products being bought by providers that give rise to serious questions about patient safety:
- Medical device systems – that is medical devices that extend their capabilities by leveraging software running on general purpose computers, and
- IT-networks – the wired and wireless networks – both local and wide area networks – that connect medical devices to their own servers and client applications, in addition to connecting them to other systems of medical devices and/or health care information systems.
Medical device systems used to be deployed on their own private local area networks. This paradigm is breaking down for two reasons:
- Private networks result in “islands of information” that make it difficult to pass information between medical device systems and the greater IT infrastructure within the provider organization, and
- Medical devices that were once relegated to specific locations are becoming enterprise applications in use almost anywhere in the provider’s enterprise.
It’s just not practical to install multiple private networks across ever increasing portions of the enterprise. A mid to large sized hospital can have 50 to more than a hundred private networks supporting medical device systems. It is admittedly pretty easy (if not cost effective) to bridge private networks to move data between medical device systems and applications like ADT and EMRs. The real driver that is tearing down private medical device system networks is the fact that many devices are used across the entire enterprise rather than individual departments and units.
Cisco Changing to Support Health Care
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.
AAMI 2008, San Jose, Day Three
I was too beat to catch the breakfast symposium. My day started with the session titled…
Designing for the unforeseen: preparing your facility for evolving technologies
Presenters: Barrett Franklin and Sudhakar Nagavalli of KJWW Engineering; Valmik Thakare, Christner; and Dennis Minsent, OHSU.
Major trends that they see:
- Diagnostic imaging – portability
- Monitoring/connectivity
- Integration
- Clinical information systems
- Video capture
- Communications
- Transparency (RTLS)
Diagnostic imaging is moving out of conventional settings into surgery, procedure rooms and intensive care. This impacts workflow and consequently, workflow automation. Imaging is becoming an enterprise application, going beyond distributing images on an enterprise basis to include image acquisition anywhere and any time.
Patient monitoring is transitioning from disparate stand alone systems to an enterprise system. This creates specific infrastructure requirements, encompassing wired and wireless networks. Raising patient acuity and an increasing trend to spread higher acuity patients out to their medical services has increased the need for pervasive monitoring capabilities.
Integration was grouped into 3 different applications. Integration started in the operating room, and this trend evolving into a unified enterprise system. There is a growing requirement for disparate systems to work in concert, including: patient monitoring, ventilators, infusion pumps, defibrillators and information systems. This gives rise to challenges in defining a coherent network infrastructure.
AAMI 2008, San Jose, Day Two
The day started bright and early at 7 am with the…
GE Breakfast Symposium
Presented by Elliot Sloan and Leanne Cordisco, the symposium presented a vision of the future of the biomedical engineer. Elliot started off, describing how we got to where we are.
“May you live in interesting times…”
The issue that started all this – biomedical engineering – was electrical safety. Ralph Nader’s shocking expose on a rash of hospital patient deaths from electrocution stirred both the public and the industry. Nader’s shameless self promotion consumer advocacy resulted in congressional hearings, new FDA regulatory authority, and the creation of the biomedical engineering role in hospitals.
Then in 1977, the big issue was gas safety. Changes like DISS standard gas fittings, O2 low-pressure cutoffs and PO2 monitoring were the result. Already the interactions between systems of systems were creating risks that resulted in use errors, patient injury and death.
Classic systems engineering was first applied to solve anesthesia deaths in 1991. The need for systems engineering has only grown over the years, as complexity affects multiple systems in unexpected ways.
