Commercial Intravascular Optical Coherence Tomography Imaging Systems – Who’s Next, What's at Stake, and What’s Taking So Long?

I really admire Eric Swanson, one of the founders of LightLab Imaging and the author and webmaster at www.octnews.org.  I have one bone to pick regarding this article because it is a personal thing about my profession.   

I quote from his article:  

"To take over 6 years to develop a medical device product and spend ~$100M and still not be shipping when a competitor is would make most investors cringe and for engineering and product management to miss a product release date by over 4 years and counting is hard to imagine in most industries."

Now just one minute there.  I was Director of Marketing at LightLab Imaging from 2007 until they were acquired by SJM in mid 2010 , and I was the de facto product manager for the C7-XR FD-OCT platform.  The definition of "product manager" varies by industry.  In US automotive companies, and many large medical device hardware companies, the product manager is in charge of everything to do with the product and the whole team reports to him/her.

Not so, in most of the positions I have held in medical devices.  The product manager can be extremely influential in the right team environment, and quite limited in others.

So, Eric, please reconsider the ability of product management to play a role in a four year project delay.

Just sayin'

IABP not shown to reduce infarct size

This surprised me a bit.  Having cared for 300+ IABP patients during my career in healthcare I have seen first-hand what the device is capable of.  I really need to read the whole study to see how it was designed. In my personal experience it provides more benefit than just limiting infarct size.  Other benefits include, stabilizing patients in cardiac shock, a bridge to bypass surgery or PCI, cardiac output improvement to get off cardiopulmonary perfusion during cardiac surgery to name some.

Yes it is invasive, and not clinically benign, but it does save lives.

Intra-aortic Balloon Counterpulsation and Infarct Size in Patients with Acute Anterior MI Without Shock

Researching the treatment of Peripheral Vascular Disease and raising awareness

A recent study performed in Germany, named the PACIFIER trial compared a drug-coated balloon to a standard balloon for treatment of lesions in femoral-popliteal anatomy.

While the results were good, and the study was well designed, it bore the hallmark of most PVD studies:

• Small cohort.  Most PVD studies are underpowered and shouldn't be making statistical significance claims.  The reasons for this are important to note.  
• Most studies are financed by industry
• Device and pharma companies make research planning decisions based on ROI
• PVD is a relatively small market when compared to coronary disease

Unfortunately, both the industry, healthcare providers and insurance entities have unwittingly collaborated to make this so.

• PVD was/is under-served with low reimbursement rates
• Interventional Radiologists traditionally have lagged surgeons in patient referrals and now Interventional Cardiologists as well in some countries.
• PVD varies greatly in its presentation and etiology depending on the location in the vascular tree. This limits the ability extrapolate data beyond the subject anatomy.  
• I postulate that the combination of limited competitiveness, smaller interventional budgets, the willingness of smaller companies to lowball prices for market share, and the lack of peer reviewed proof of outcome improvements have kept the PVD therapeutic market the minor market segment it still is.

However, the primary co-morbidities of PVD; smoking, obesity and diabetes, make this a problem of enormous magnitude in the US especially.

IMHO the government (NIH, CDC) must step up and address this issue.  All the years of treating the problem and it is still being addressed with trickle-down products from the coronary disease market.  The result is poorly targeted tools and a dearth of solid data on the complex underlying disease state.

Anybody with these co-morbidities and any kind of symptoms; calf pain, trouble walking as far as you used too, skin lesions, etc. should seek medical consultation as early as possible.  I urge you, your friends and family to help raise awareness of this growing problem by any means possible.  

TCTMD.com

http://www.tctmd.com/show.aspx?id=107192

The link to the NG article on virus-fighting shark bits

http://news.nationalgeographic.com/news/2011/09/110919-sharks-drugs-medicine-viruses-science-health-squalamine/?source=link_fb20110919news-sharksviruskiller

Virus fighting shark bits. From National Geographic

A cholesterol-like compound found in dogfish sharks' tissue has been shown to combat several viruses that cause hard-to-treat human diseases, such as dengue fever and hepatitis, a new study says. 

Called squalamine, the compound is already in human clinical trials for cancer and eye disorders, and several hundred people have been exposed without major side effects.

The new study revealed that squalamine can also disrupt a virus's life cycle and prevent it from replicating in both tissue cultures and live animals.

Though there are plenty of drugs to treat bacterial infections, there are few pharmaceuticals that are effective against viruses. Current antiviral drugs are highly specific—each targeting just one strain of a virus—but strains can easily mutate and become resistant to the medication.

New hope for start-up's

Having trouble raising funds for your start-up?  Follow the example of GI Dynamics Inc., who went public in Australia where they have already achieved regulatory approval.  An early investor in the company was quoted as saying; "When companies launch a product in a country, investors there hear buzz.....Secondly he added, Australian investors have more of a buy-and-hold mentality that US investors...".

Their product, named "Endobarrier", is intended to change the very invasive and risky GI bypass surgery into an endoscopic procedure.   

New efficiencies in healthcare

Good article in the Boston Globe today describing a new system being trialed at the Dana Farber Institute in Boston. They are asking employees and patients (showing first names only) to wear badges to show name, location, how long they have been waiting, status of rooms (empty or in use) and several other functions to increase efficiencies. Since time really does equal money in healthcare this new application of existing technology is a great example of starting a company based on a simple, but creative concept.  The developing company is Versus Technology.