Archive for July, 2014

When did Pharma miss the Innovation Pride Parade?

A recent article identified four basic skills that new leadership in pharma needs to be successful in the arena of consumer health. The author, Michael Winter, addresses the topic from his perspective as an executive headhunter, with the expertise and obvious vested interest in helping to find, source and
pride paradeplace talent.

Winter observes that the capabilities, talents and skills that built pharma into the very successful industry sector it has been aren’t necessarily the same attributes that will make pharma successful over the next 5, 10 or 20 years.

“What got us here won’t get us there,” has never been truer than it is in pharma today.

The Skills Needed
The clinical research and development skills needed to produce new drugs will always be critical to pharma’s success, but our approach to the marketplace needs to be rethought and adjusted. The kind of marketing expertise needed in today’s environment has more common with successful consumer goods companies than traditional pharma.

This realization has spawned a growing contest for talent between pharma and consumer goods companies. In some cases pharma is trying to poach senior consumer executives. To be successful, however, pharma needs to first make itself an attractive destination for this type of experienced hire.

Most consumer executives look at an industry like pharma and say, “I don’t know… It looks complicated. It’s a highly regulated industry. They’ve got business model challenges. They’ve got brand issues. I’ve done well on the direct consumer side. Why would I ever leave my successful career here and move over into health? That just seems like a recipe for disaster.” Read Full Article Now »

FDA Loosens Regulatory Reins on Digital Devices

Over the past year there have been a series of draft letters from the FDA on the approval process for medical devices, particularly in the arena of digital health. After several years of being a hyper-vigilant regulatory agency and effectively slowing down the approval process for new products, the FDA has begun to relax its approval requirements, especially for digital health products.

FDA3Historically, the FDA has divided medical devices according to device classification and risk to patient and user. Class I includes devices with the lowest risk such as an activity tracker like a Shine or Fitbit and Class III includes those with the greatest risk such as pacemakers or implants.

The class indicates what level of premarket approval is necessary. Most Class I and Class II devices are exempt from the 510(k) Premarket Notification application. Most Class III devices require full Premarket Approval (PMA), which generally requires clinical data to support claims. Read Full Article Now »