Medical Devices Today

Comparative Effectiveness and the Medical Device Industry

 
An exclusive Q&A with Bill Sarraille, Senior Partner with Sidley’s Health Care Practice.

 
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Bill Sarraille discusses the widespread concerns regarding comparative effectiveness and its potential impact on the medical device industry. According to Sarraille, "We’re going to be in a situation where companies will have to think long and hard about the strategic and tactical decisions around what kind of research to do and how to do it, because in an age where there is transparency about clinical trial research, the reality is that the kinds of research that companies will be doing from a comparative effectiveness perspective will be very public." He added, "If companies don’t conduct comparative effectiveness research in a careful way, a thoughtful way, it’s quite possible that they could develop evidence that would be very contrary to their interests."

Bill Sarraille shared his insights with Medical Devices Today about:

• The new challenges comparative effectiveness are likely to create for the medical device industry, including some pitfalls to be on the lookout for.
• The risks that comparative effectiveness will create for the health care industry as a whole.
• The international implications of comparative effectiveness and the lessons we have already learned about it from its use in Europe and Great Britain.

• Click here to download the exclusive 6-page Q&A with Bill Sarraille

The Promise of Social Media and Web 2.0 for Life Science Companies

An exclusive Q&A with Coleen Klasmeier, Partner and Head of Sidley's FDA Regulatory Practice and former Staff Attorney/Special Assistant to the Chief Counsel of FDA.

 
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When Coleen Klasmeier talks about social media and the potential of Web 2.0 to her life science clients, she is talking about more than Twitter or Facebook.

"What we're talking about are the unprecedented opportunities (and challenges) the Web presents the life science industry," said Coleen Klasmeier who heads Sidley's FDA Regulatory Practice in Washington DC. "Pharma, medtech and biotech companies are just now starting to dip their toes in the largely untested regulatory waters that the enriched online communities of doctors and patient groups have to offer these companies," she added.

Coleen Klasmeier shared her insights with Medical Devices Today about:

• How some forward thinking medical device and other biomedical companies are taking advantage of social media while others sit on the sidelines
• Some of the complex business, legal and regulatory implications of social media for the life science industry
• How prepared the FDA and other regulatory agencies are to handle the issues created by Web 2.0

  Click here to download the exclusive 5-page Q&A with Coleen Klasmeier