FDA MDDS Webinar
As the FDA grinds through the comments submitted in response to their proposed rule for medical device data systems (MDDS), the market awaits the final rule. Regardless of changes between the proposed and final rules, vendors who may be regulated under the new rule will have limited time to prepare.
Awhile back, I was contacted by ComplianceOnline to author a webinar on the FDA’s proposed MDDS rule. After some discussion, we agreed on the following pithy title: The FDA’s proposed Medical Device Data System (MDDS) rule and its implications for currently regulated and unregulated vendors and providers. The key objectives for the webinar are to provide clairification on the proposed rule and explore the consequences for those involved with MDDS – vendors and hospitals.
You can read a description and register for the webinar here. Attendees are encourage to submit questions – which I will answer during and after the webinar.
Alas, the webinar is not free. But compared to what it would cost in my time to lay out the proposed MDDS rule and its implications in detail, the price is a bargin.
If you have any questions about the webinar or MDDS, feel free to contact me (scroll down to the bottom of the page). You can also leave questions on the web page promoting the webinar.
Healthcare Unbound 2008
This week was the Healthcare Unbound conference. Between the considerable innovation in this market, and the openness with which presenters and attendees share information and ideas, this is always a terrific conference.
The following are some notes from some of the more interesting presentations – be sure to keep scrolling, this is a long post! I’ll follow this up with a post on my presentation at this year’s conference, “How the Network Effect Impacts Adoption of Healthcare Unbound Technologies,” and a wrap-up post.
At 8 am Monday morning, Teri Louden kicked things off. She started her career at Baxter Travenol in the 1970s. Referring to The Graduate, Baxter’s innovative technology of the day was plastic IV bags. Today, things have come a long way from plastics to Healthcare Unbound.
There have been few breakthrough industry segments over time – disease management, home infusion therapy, outpatient surgery – and Healthcare Unbound (HU) is an important pioneering new industry segment.
Teri prognosticated that many of the really breakthrough solutions in health care will come from companies outside of health care – mentioning Intel, Qualcomm, and other electronics and communications companies.
Using CardioNet as an example, Teri described how a new type of solution presents substantive challenges for adoption and effective use. The CardioNet value proposition was unique and required new ways of selling, patient use, and reimbursement.
She introduced Vince Kuraitis and David Kibble, and their topic: The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound
The Personal Health Information Network (PHIN): Opportunities and Implications for Healthcare Unbound
Vince introduced the topic with a classic example of the network effect, phones. He asked, what is the value of a single phone? The health care industry is currently the equivalent of two phones representing one to one solutions. The real value comes to the fore when many phones are interconnected, allowing users to contact many other users whenever they want.
