As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud. Maybe I'm too close to it...

Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar. For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002. This is not the only example of a request for a device...

So far I’ve chronicled my visit to Canada by focusing on what I’ve learned so far about the country’s focused efforts on growing its medical device industry – which is, of course, the primary purpose of the Advanced Medical Devices Media Tour, organized by the Ontario Ministry of Economic Development and Innovation (MEDI). But in addition...

Earlier this year GE Healthcare established its first global Pathology Imaging Centre of Excellence (PICE) in Toronto, Ontario. GE and its digital pathology joint venture, Omnyx, will invest $7.75 million along with a $2.25 million grant from the Health Technology Commercialization Program created by Ontario’s Health Technology Exchange and funded by the Ontario Ministry of Research and Innovation. Planned collaborative R&D partnerships are expected to bring an additional $7.2 million, for a total investment of $17.2 million over the next three years. Considering GE is a massive global corporation with locations all over the world and its JV Omnyx is...

Hockey isn’t the only thing our northern neighbors do well. Canada – Ontario in particular – knows innovation. While the U.S. has struggled in recent years to find ways to maintain its leadership position in medical innovation – Ontario has its own strategy that seems to be working out quite well for the Canadian province. More than $13.9 billion in industrial and university-based R&D is performed in Ontario every year. So, what’s their secret? Ontario offers all the key ingredients for attracting life sciences companies: the right people, the right cost, and a...

As most of the U.S. population prepares for the rapidly-approaching Thanksgiving holiday, I will be visiting our neighbor to the north, feasting my eyes on all that Ontario has to offer in the way of advanced medical devices. Medical Device Daily has been invited by the Ontario Ministry of Economic Development and Innovation (MEDI) to participate in a medical device media tour of the Canadian province. Throughout my visit, I plan to post frequent blogs here about my experience on the tour and what I learn about Ontario’s medical device industry. I also plan...

Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far. It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and...

Recently I posted a blog here about my observations of the medical device space over the last five years and how it has changed during my five-year tenure at Medical Device Daily. Like the industry, we too have changed a great deal since I joined the MDD staff in October 2006. The first big change during that timeframe is the launching of Medical Device Daily Perspectives, our free, weekly e-zine, MDD Perspectives offering viewpoints on developments within the med-tech industry. In that, we aim to go beyond the news to provide you with a fresh outlook on the companies, trends,...

I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

Medtronic has the potential to be a trend setter with its attempt to have drug eluting stents (DES) treat erectile dysfunction (ED). The device maker recently moved one step closer in this effort as it reported that it had completed its ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors), feasibility study. The device, which hasn't been named yet, will be inserted into the pelvic area of the body. More specifically the stent is delivered using a catheter threaded up to the pelvis, where the pudendal artery is located. It...