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Do you ever wonder how internet-connected medical devices and Bluetooth technology could affect the device market? Or how about how it may affect your interaction with your physician? “Trust Me, I’m Not a Doctor—The Changing Nature of Healthcare,” a new white paper from Nick Hunn of Laird Technologies, argues that such technology is posed to disrupt the balance of power in the doctor-patient relationship. Patients should have the power anyway, right?

This could have a variety of implications for medical OEMs. Hunn compares the evolution of medical technology to that of consumer devices—portable TVs, CD players, and other mobile devices changed the game in those markets. Hunn says that “[medical manufacturers] are still hung up on producing expensive devices designed for clinicians,” and that “they need to start thinking about what happens to the market when the clinician is excluded from it.”

HLB Inc. recently released a compellation of comments from its designers,
engineers, and researchers on the future of medical device.

One prediction is the self-training of medical device. According to the
firm, technologies will mimic those used in the Wii and iPhone. Avatars will
be used to train doctors, surgeons, staff, and patients in the use and
operation of medical devices. Company representatives will also use avatars
to simulate the operation of medical equipment. This will allow doctors and
surgeons to determine if the purchase of a new piece of equipment makes
sense.

Another prediction is that companies will move a “Green” business model that
emphasizes reduction of medical waste. This trend will promote development
of smart technology that can enable sterilization of previously single-use
equipment (syringes, catheters, IV tubes). The business model could further
development of biodegradable body navigation devices.

In addition, the company cited other trends, as follows:

• Movement of medical device from hospital to home.
• Creation of smaller, handheld and protable devices.
• Development of home diagnostics using microelectromechanical safeguards to prevent misuse and inaccurate readings.
• Development of diagnostics that make use of very small fluid samples.
• Increasing use of wireless technology that eliminates the need for expensive cables.

CDRH is scheduled to release a Level 1 draft guidance document on the sex and gender differences in cardiovascular medical device trials reviewed by FDA. Medical Technology Learning Institute will host a workshop on December 9, 2008, in Silver Spring, MD, to explore the history of including women in cardio trials, as well as regulatory considerations, treatment biases, and recruitment challenges.

FDA presents recommendations for the guidance document and rationales behind those reccommendations. The guidance document includes items that may affect medical device companies and others involved in the design and conduct of such studies.

Speakers include Kathleen Uhl, MD, Director, Office of Women’s Health, FDA, as well as various experts from industry, such as speakers from Boston Scientific, Maquet Cardiovascular, Medtronic, CardioMed Device Consultants, Thoratec (invited), and Abbott Vascular.

Researchers at Emory University (Atlanta) have found that the combination of ultrasound waves and drugs work faster to dissolve blood clots in patients with deep vein thrombosis (DVT) than medications alone. Karthikeshwar Kasirajan, MD, assistant professor of surgery at Emory’s School of Medicine, said that using both ultrasound and drug treatment helps to restore flow, prevent valve damage, and could prevent a pulmonary embolism as well. The study involved 37 patients (16 with DVT and 21 with acute in-situ arterial thrombosis) who were treated with a clot-dissolving drug and ultrasound. The technology was used to loosen proteins in the blood clots, which enabled a faster deliver of the drug to the clot. The patients with arterial thrombosis and all but six patients with DVT saw their clots completely dissolve.

One of the reasons Cook Medical (Bloomington, IN) is doing so well is the fact that most of its technologies are used in procedures that aren’t elective. Yesterday the company held what has become an annual meeting for the media and analysts during the week of VEITH, a symposium for vascular surgeons and cardiologists in New York City. Cook Medical achieved double-digit growth and reached $1.5 billion in annual sales, and is continuing to build up its global reach with several manufacturing facility expansions and worldwide product launches. This year, the company made significant investments in its manufacturing sites in Ireland ($25 million euros), Australia, Denmark, and Shanghai, and is expanding Cook Pharmica by 100% and Cook Urological by 50%. Cook also opened new offices in Japan and acquired shonin, which enables the sale of the company’s products in that country.

The meeting focused on Cook’s Peripheral Intervention and Aortic Intervention strategic business units (SBU). The company continues to achieve strong success by maintaining its basic core philosophy of working directly with physicians to create new products (as opposed to growth via acquisitions), said Rob Lyles, vice president and global leader of Cook’s Peripheral Intervention SBU. For 2008, he projected up to 15% growth for the SBU and forecasted 20% growth for 2009. Within peripheral intervention, Cook holds the #1 and #2 place in inferior vena cava (IVC) filters (30% global market share), embolization coils, and accessory devices (29% global market share). The company’s main competitors in this space are publicly-held Boston Scientific, Cordis, Abbott, Terumo, and Bard.

Lyles sees a huge opportunity for Cook’s convergent technologies in 2009. In September, the company completed enrollment for an international clinical trial involving its Zilver PTX, a drug-eluting peripheral vascular stent. While companies like Cordis and Abbott have expressed interest in this space, Lyles is confident that Cook will be the first to market and anticipates a product launch in Europe early next year. He called the 12 month data on the stent “awesome” and is awaiting the 18 month results.

Another market opportunity for convergent technology is in the prevention of catheter-related bloodstream infections. With CMS no longer reimbursing for the condition (it is considered a “never event”), hospitals need to get serious about preventing these infections, said Lyles. He added that Cook’s Spectrum PICC line (peripherally inserted central venous catheter) has the potential to be a disruptive technology in this area.

Cook’s hold on the endovascular aneurysm repair (EVAR) market remains strong as well. Of the $1 billion EVAR market, Cook has 35%, according to data cited by Phil Nowell, director and global leader of the company’s Aortic Intervention SBU. Gore comes in second with 30% and Medtronic third with 27%. Although Cook holds the top spot in this arena, Nowell recognized several significant barriers to market–rising R&D and regulatory costs, issues related to royalties and intellectual property, and profitability challenges with the rising cost of manual production.

John Dingell (D-MI) has been replaced as chair of the House Energy and Commerce committee by Representative Henry Waxman of California, reports Los Angeles Times’s Janet Hook.

Hook says that the regime change has come because House Democrats are unhappy with Dingell’s defense of the auto industry. Waxman has a much stronger stance on global warming than Dingell.

To the device and other medical industries, however, the change may mean an even higher level of scrutiny from the Hill. Waxman is notoriously critical of the pharmaceutical industry, and, to an only slightly lesser degree, the medical device industry.

Waxman’s promotion to chairman was the result of a vote during a closed meeting of the Caucus. The committee approved Waxman, 137 to 122. This change upsets the seniority system of the House.

Myriad Genetics won its appeal in a case that many are following. The Utah-based company holds a 2001 patent on one of the first genetic tests for detecting breast and ovarian cancer. According to the Financial Times, while other diagnostic companies have licensed similar technology to ensure widespread use, Myriad has insisted on keeping tight control of its tests. Some European countries have criticized the patent award to Myriad, arguing that it impairs the development of improved diagnostics. However, on Wednesday, the European patent office sided with Myriad and reinstated the company’s patent.

Dr. Adrian Kantrowitz, a cardiovascular surgeon, died at age 90 in his home in Ann Arbor, MI. Kantrowitz is famous for several accomplishments, including the development of more than 20 electronic and medical devices that assisted heart patients and paraplegics. With the help of his brother, Kantrowitz developed an intra-aortic balloon pump used for counterpulsation. According to the Los Angeles Times, more than 3 million people have been treated with the balloon-pumping device since it came on the market in the 1980s.

Kantrowitz also contributed to a series of left ventricular assist devices (LVADs), started the company LVAD Technology Inc. (Detroit), and developed one of the first implantable pacemakers.

Kantrowitz was both a pioneer in the device industry and the operating room.  He made headlines back in June 1966 when he performed the first pediatric transplant—it was the only the second human transplant to be performed in the world. He also carried out the world’s second implantation of an LVAD device.

With such a rich legacy, it comes as no surprise that Kantrowitz was a workaholic. The Times reports that he worked 18 hours a day, six days a week.  It seems his love for the medical field was contagious. His three children work in cardiology, radiology, and neurosurgery.

Photo courtesy of the Associated Press.

President-elect Barack Obama has selected former senate majority leader Tom Daschle as his HHS secretary, according to The New York Times. Daschle has long been a rumored candidate for a position in the Obama administration. He was in consideration to be Obama’s chief of staff (Rahm Emanuel took the position), and he was one of a handful of candidates for HHS secretary.

“Tom Daschle would be an excellent choice,” said former HHS secretary Tommy Thompson at Cleveland Clinic’s 2008 Medical Innovation Summit last week. Although Thompson was doubtful that Daschle would accept the post, Democratic officials have confirmed that Daschle has accepted Obama’s offer.

Yesterday GE Healthcare announced three IT initiatives that it is confident will improve patient care while driving down costs. At a media event in New York City, GE’s top healthcare officers, along with industry leaders, provided the framework for its plans, as well as some insight on where and how they fit into the global market.

GE’s IT Initiatives

1. Digital from Day One. The initiative provides the tools for a completely digital operation, from patient check in to electronic medical records. It will also be present at developing hospitals in emerging countries. For example, Aspetar Hospital in Qatar is one of the first sites partnering with GE on the solution. The company’s goal is to implement the program into more than 3000 doctor offices and new hospitals through 2012, giving access to a global network of healthcare groups. According to the president and CEO of GE Healthcare IT, Vishal Wanchoo, the initiative enables institutions, hospitals, and doctors to provide a model of best practice.

2. Collaboration with Intermountain Healthcare and Mayo Clinic Rochester. The goal here is to bring breakthrough medical research (that has been published) to patients sooner. Clinicians will have the most current information to help them in decision making. Based in Utah, Intermountain Healthcare is a network of 21 hospitals, clinics, and other healthcare sites.

3. IT Collaboration between GE Healthcare and its partners–Intermountain Healthcare, Montefiore Medical Center (New York), Mayo Clinic Rochester, and the University of California’s San Francisco Medical Center (UCSF). These groups are collaborating to develop an open architecture healthcare IT system that will enable patients to be more active in their healthcare and seamlessly share data with clinicians. It will also help doctors share best practices. “Public expectations related to healthcare have radically changed in the last 10 years,” said Michael Blum, MD, Chief Medical Information Officer at UCSF. He added that healthcare IT is at the cornerstone of meeting this expectation. Now the issue to tackle is, if the use of certain healthcare IT systems is doable, why aren’t they being implemented?

Jeff Immelt, chairman and CEO of GE, addressed where the company stands in these tough economic times (good–2008 could be one of GE’s highest earnings year in its history) and the future of healthcare (again, improving quality at a lower cost). He named four important issues at the forefront of healthcare:

- Improving access and the quality of healthcare for the uninsured
- Transparency and choice–more will be known about the quality of healthcare, and early detection, along with the spread of information will be critical
- Innovation–it’s a growing part of gross domestic products (income) around the world, and strong pipelines are crucial to the future of healthcare
- Systems efficiency and IT–it’s not a technological challenge, but rather a workflow challenge.

So, when considering the above factors and current economic conditions, how can a company play a strong role in the industry’s future? Immelt named the ability to have staying power, a dedication to vision, good leaders within the company, instituting a marriage of good process capability with software, and collaborating with industry.