A Tale of Two Specialties

X-ray image of hip, with orthopedic implant
Image via Wikipedia

If you haven’t already heard the big news from last week, Johnson and Johnson’s Cordis subsidiary announced its withdrawal from the drug-eluting (DES) stent market, a momentous event for the firm that launched the first DES and created a new multi-billion-dollar medical device sector. Cordis is also shutting down its Conor MedSystems DES business, which it acquired for $1.4 billion in 2007. My reaction: Wow!

Meanwhile, the same week, the NY Times reported that metal-on-metal hip implants may become “the largest product liability cases of this decade.”  The FDA website states that “on May 6, 2011 the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers.”

Two long-term implants. Two medical device sectors. One critical difference.

Continue reading “A Tale of Two Specialties”

The Patient Graph

Social Graph
Image by Matthew Burpee via Flickr

We all know social networking as a major time-suck, real-time news source, and practical job-hunting tool. We also know that patients can often get better health information from the web than they can from their health care provider (e.g. WebMD.com). When ‘social networking’ meets ‘the search for health information’ we get online patient communities. Facebook, Twitter and GetSatisfaction are just the tip of the social iceberg. PatientsLikeMe and CureTogether are just two of the best known of dozens of web-based social networks for patients. The NY Times calls patient-centered social networks a “Lifeline for the Chronically Ill.” For medical device companies, patient-centered social networks bring new challenges and new opportunities.

As online communities have evolved from BBS’s and usenet groups, to forums and yahoo groups, to social networks and blogs, the quantity and quality of direct patient-to-patient interaction has dramatically increased. In March 2009, an article in Forbes called these new patient-centric social networks a disruptive innovation in patient care (Disruptor of the Month: Creating A New Kind Of Health Care Community by Renee Hopkins Callahan). If you’re developing a novel device or a novel procedure, there’s a chance you are already the subject of an online patient conversation. The more patient-facing your product (either used-by or implanted-in a patient), the more likely patients will share their experiences with each other online.

Any day now, the FDA is expected to issue some of its long-awaited guidance on its approach to the regulation of social media and the internet. Social media, though, does not move on the FDA timeline. While this blog post may need an update when that guidance comes out, medical device companies are already way behind the social media curve.

What does online patient interaction mean for medical device companies? How can medical device companies interact successfully with patients online?

Continue reading “The Patient Graph”

510(k) Action Items: FDA 25, Industry 0

Source: FDA-OCI
Image via Wikipedia

On 19 January 2011, the FDA unveiled its much-awaited proposal for changes to the 510(k) process.  Medical device industry representatives were generally pleased with the modest scope of the proposal. In a press release, AdvaMed president Stephen J. Ubl called the plan “clearly a good first step that will address some of the major problems with the program.” Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA) commended “FDA leadership and staff for working with various stakeholders in an open and constructive process to develop consensus proposals that improve patient access to safe and effective therapies.”  The NY Times quoted Medtronic CEO William A. Hawkins as stating “This is a more balanced approach that sends a positive signal to industry that the F.D.A. is engaged, listening and concerned.”

Patient safety advocates were underwhelmed. Public Citizen’s Sidney Wolfe stated “the FDA is not being forceful enough about improving the safety and effectiveness of new devices.” Dr. Rita Redberg (UCSF, Editor of Archives of Internal Medicine) told theHeart.org that she is “worried about the implanted high-risk devices that are getting cleared without any data. There are lots of examples of stents, inferior vena cava filters, heart valves, that are [cleared through 510(k) but] not low risk.”

But is the FDA’s modest proposal really a good outcome for the device industry?

Continue reading “510(k) Action Items: FDA 25, Industry 0”