Little news and BIG NEWS

This morning Senseonics announced that Dr. Francie Kaufman has been appointed Chief Medical Director. Per a company issued press release;

“Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the appointment of Francine R. Kaufman, M.D. as Chief Medical Officer, effective immediately.”

As everyone in the diabetes world knows Dr. Kaufman held the same position at Medtronic until her supposed “retirement” late last year. We have long known that this retirement was just a cover story and that Dr. Kaufman had differences with the Medtronic management team. Differences which lead to her “retirement”.

This news is hardly shocking as Dr. Kaufman brings a wealth of experience plus a solid relationship with the FDA. (Ironically just yesterday everyone learned that Dr. Scott Gottlieb the current FDA commissioner is leaving the agency sometime next month.) This experience and relationship should help Senseonics as they move forward.

In another announcement involving another ex-Medtronic executive BioSig hired Dr. Barry Keenan as Vice President of Engineering. Per a company issued press release;

“BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that the Company appointed Dr. Barry Keenan, Ph.D, MBA, PMP to head up BioSig’s advanced product development.”

However, the biggest news of all that likely will not be announced until late May or possibly after the ADA conference in early June is the departure of Hooman Hakami Executive Vice President and President Diabetes at Medtronic. Sources inside Northridge have already noted that someone else has moved into Mr. Hakami’s office.

While this is big news it is not surprising news given how poorly the diabetes unit has been performing. Now we have no idea if Mr. Hakami is leaving voluntarily but honestly it doesn’t really matter as this unit is in complete disarray and in desperate need of new leadership.

The fact that no one has replaced Dr. Kaufman since her “retirement” is a perfect example of how bad things have become. As we noted earlier Dr. Kaufman has a solid relationship with the FDA skills which are badly needed as Medtronic has several key initiatives underway involving the FDA.

It’s also worth noting since Dr. Kaufman “retired” several other key executives have left the company as well not to mention the many who have been shown the door.

Like so many who have come before him Mr. Hakami came in with grand visions of transforming Medtronic from just an insulin pump company to a complete diabetes company. Yet the debacle in the CGM unit could well be the straw that broke the camels back. Omar Ishrak the company’s CEO who also came from GE, has looked very foolish stating that the stand alone CGM system which is inferior to the Dexcom and Abbott systems would become a billion-dollar franchise.

Even when his own people were telling him this was a pipe dream Mr. Ishrak insisted on publicly backing this dog of a product.

It could well turn out now that the FDA is investigating the company that the CGM sensor the straw that stirs the 670G drink will be the Luke Skywalker that destroys the Death Star. We suspect Dr. Kaufman was aware of this, knew she was being setting up as the fall guy or fall lady in this case therefore prompting her to “retire”. Being the smart guy that he is we also suspect Mr. Hakami knew two things the CGM was a major problem and that given how numbers focused the company is there was no way he could fix the problem and still hit his number.

Whoever replaces Mr. Hakami better be prepared for a very rocky ride as the diabetes unit is facing several critical issues not the least of which is the FDA investigation. That goose that is laying all those profitable golden eggs is threatened. The company no longer has the coolest toy in the toy chest. The competition is not only emboldened but financially strong and ready to compete. The insulin pump world is changing and without major and very costly design changes Medtronic will be seen as old school.

It may be time finally for Medtronic to do what was once unthinkable and exit the diabetes space before it’s to late. They’ve had a great run made boatloads of money, but the run is coming to an end. The last thing they need is for this golden goose to become an albatross around their neck. Nor do they want to pull an Animas and be unable to sell the unit.

The empire has ruled the Galaxy for a long time, but the Force is now strong with the rebels. Better to exit now before Luke blow’s up the Death Star.