Third Medical Device Connectivity Conference

Third Medical Device Connectivity Conference

This September 8-9, in Boston, will be the third Medical Device Connectivity conference. We’re returning to the Joseph B Martin Conference Center at Harvard Medical School – a really nice facility with great food. Of course, the ambiance and cuisine is secondary to what you’ll learn at this year’s conference – still the only event dedicated to medical device connectivity.

Since last year’s conference so much has come to pass:

  • The FDA published their final rule for Medical Device Data Systems, and signaled their intent to regulate health care providers who develop their own MDDS solutions.
  • The FDA also published the long anticipated draft guidance on mobile apps, clarifying the boundaries around what is and is not regulated medical device software, and laying out a bit of the FDA’s enforcement strategy.
  • The transition of health care technology from the hospital to home health has also received some attention from the National Research Council in their report, Health Care Comes Home: The Human Factors.
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Reporting from AAMI 2011

Reporting from AAMI 2011

After missing last year’s meeting in Tampa, I’m back at AAMI – one of the two events that I try to attend every year. The focus on connectivity has increased as there is a full track devoted to the topic this year.

One change this year, is that my blog posts from the conference will be appearing on the Medical Electronic Design magazine blog, found here. As usual, I’ll also be taking lots of photos, some of which may also be posted on the MED blog. Eventually most all the photos (the good ones that aren’t confidential) will be posted on my Flickr account, here.

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Developing a Regulatory Strategy Workshop

Developing a Regulatory Strategy Workshop

I have an opportunity to conduct a post-conference workshop at this year’s Healthcare Unbound conference. This year’s event is in San Diego, July 11-12 at the Manchester Grand Marriott. The title for the workshop is, Developing a Regulatory Strategy for Your Healthcare Unbound Product. The workshop will be conducted the afternoon of July 12th. You can read the workshop description at the end of this PDF document.

The rationale behind the workshop is the need to clear up confusion on the part of many product developers regarding regulatory issues like,

  • Is my product a regulated medical device?
  • What does it mean to be regulated?
  • If I don’t want to be regulated, can I avoid regulation – and if so, how?

Ideally, we can structure the workshop around attendees actual products and situations. This, of course, will depend on folks registering in advance with sufficient lead time to actually prepare some content around their unique situations. Using participant’s products as case studies should be more engaging and relevant for everyone. If you’re registered for the workshop and want to provide a case study, let me know by completing this contact form.

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Announcing the 2011 Medical Device Connectivity Conference

Announcing the 2011 Medical Device Connectivity Conference

This year’s connectivity conference is scheduled for September 8-9 at the Joseph B. Martin Conference Center at Harvard Medical School in Boston. This is the same location as the inaugural conference in 2009, and was a great venue for both general sessions and break-out tracks. Exhibitor’s booths line the wide walk ways that lead to the conference rooms, rather than a separate lobby (or tent as we had in San Diego in 2010).

I’m already working to line up speakers – if you’ve got a topic to suggest, or want to present yourself, let me know.

The focus of this year’s conference may extend a bit beyond the acute care (hospital) market into ambulatory settings (patient’s homes and use in daily life). Now there are already several conferences on connectivity in ambulatory markets (Healthcare Unbound, mHealth Summit, Connected Health Symposium), but they focus little on specific connectivity issues.

Conference topics typically come from recent and current issues that crop up  in my consulting practice, and buzz in the industry (which is where you come in). Here are some of the topics that are being considered for this year’s conference:

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mHealth Summit, Washington DC

mHealth Summit, Washington DC

This week I’m at the mHealth Summit, an event bringing together research (academic), technology (business), and policy (NGOs and government). On Tuesday (November 9) I’ll be on the panel, Validation and Practical Deployment of Wireless Health, at 11:30 (Room 102 A & B). I’ll be touching on the differences between verification and validation testing, and the challenges of simulated validation testing. The panel will be discussing what constitutes sufficient objective evidence for validation testing and different approaches to validation from both a technical, clinical and business perspectives.

The event is just kicking off as I’m writing this (loud techno music before the speakers come up to the podium). Focus is squarely on wireless broadband (cell phones) offering ubiquitous connectivity.  Applications discussed provide education, diagnostics, therapy delivery and monitoring.

The Twitter hash for this conference is #mhs10. The opening keynote is being held in a full ballroom at the Washington DC Convention Center. There are an estimated couple thousand attendees– I’ll provide an official number later.

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Medical Device Interoperability Workshop

There is a FDA (CDRH) Workshop on Medical Device Interoperability scheduled for January 25 – 27 at the FDA’s White Oak Campus in Silver Springs, MD. Here’s a link to the meeting’s official web site, which includes a number of downloadable files on the agenda, meeting logistics and background.

There is little question the workflow automation and intelligence offered by interconnecting medical devices can improve patient safety. There’s also little doubt that there is significant market demand for such solutions.  For example, if hospitals could purchase PCA pumps and SpO2 monitors that were interoperable, i.e., the monitor could suspend drug delivery at the first indication of respiratory arrest, such a capability would quickly become a standard of care. Interoperability is a huge opportunity.

There is no doubt that there are unintended — and in some respects, unregulated by the FDA — systems of systems made up of medical devices  sold and in use by health care providers. At the most basic level, there are medical devices with serial ports that were never intended to provide connectivity (or Medical Device Data Systems as the FDA called them in a draft rule issued almost 2 years ago). At the other extreme, you have systems like closed loop infusion therapy delivery, made up of components that are both regulated and unregulated, and that were originally developed with little or no thought to the demands of interoperability. This is a problem.

The FDA’s been interested in this area for some time. Way back in 2005, the FDA held a workgroup to discuss the system of systems issue regarding networked medical devices (see the blog posts here, here and here).  The outgrowth of this meeting was IEC 80001, which is scheduled to be completed this year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices. (I can’t help but wonder why this is still a “draft” guidance.) Also back in 2007, the FDA provided a rather limp statement on interoperability at the 2007 conference on Medical Device Interoperability and High Confidence Software (see the posts in this search). (Offered as the first example of the FDA’s interest in interoperability is their dubious buy-in to the questionable patient safety benefits of new medical device unique device identification requirements was not inspiring — more here.)

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