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....
November 26th, 2008
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CDRH is scheduled to release a Level 1 draft guidance document on the sex and gender differences in cardiovascular medical device trials reviewed by FDA.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.
November 25th, 2008
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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.
November 24th, 2008
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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...
November 21st, 2008
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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.
November 20th, 2008
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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,...
November 19th, 2008
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Top management at FDA is being accused of corruption by scientists in a letter. It says that managers interfered with scientists responsibilities to ensure the safety and efficacy of medical devices. According to the letter, "misconduct reaches the highest levels of CDRH management including the Center Director and Director of the ODE." The accusations of coercion and intimidation have led Representatives John Dingell (D-MI) and Bart Stupak (D-MI) of the House Energy and Commerce Committee to begin a congressional investigation. They believe FDA experts were "ordered, intimidated, and coerced" to modify scientific reviews, conclusions, and recommendations on devices. The scientists claim they were forced to accept data that wasn't scientifically valid. Bloomberg News...
November 18th, 2008
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MassMEDIC's 10th Annual MedTech Investors Conference showcased a range of devices from 25 start-up companies. Innovations included a line of knee implants and instrumentation that provide a minimally invasive alternative to conventional knee replacement surgery from Conformis Inc. (Burlington, MA), and a noninvasive body scanner that detects and measures, pain and injury, while identifying the tissue involved from Signal Insight Inc. (Freeport, ME). Other Massachusetts companies that displayed their technologies included the Institution for Pediatric Innovation Inc. (Cambridge), Smart Surfaces Inc. (Somerville), NMT Medical Inc. (Boston), and Confidisc Medical (Southampton). More than 400 venture capitalists and medical device business leaders attended the MassMEDIC event, which was held on Friday. Massachusetts has the second largest concentration of medical device development and manufacturing in the country. The state is home to more than...
November 17th, 2008
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Image courtesy of William Paul Segars of Johns Hopkins In Poe's "The Telltale Heart," an imagined heartbeat drives a murderer to confess his crimes. The heart is powerful in literature, but it is even moreso in reality. Its so powerful, in fact, that its energy can be used to run implanted devices. A UK-based consortium of companies announced it has successfully designed and clinically tested an in-body model microgenerator that converts energy from the heartbeat into power for implanted medical devices. The Self-Energizing Implantable Medical Microsystem (SIMM) augments existing battery for devices such as pacemakers, and implanted cardioverter defibrillators. In preclinical...
November 11th, 2008
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A new president will undoubtedly bring change in some form, but what does this mean for the medical device industry? Unfortunately, we all know that the same issues and problems won't instantly disappear. Healthcare reform, inadequate FDA funding (challenged further by the rising deficit and financial crisis), reimbursement, product safety and liability lawsuits, user fees--the list of challenges you face continues. The device industry has mane concerns, but changes will happen under President-elect Barack Obama's watch? The industry is already abuzz with speculations about who will be nominated for the position of FDA commissioner. Among the numerous rumored candidates are Steven Nissen, MD, chair of the department of cardiovascular medicine at The Cleveland Clinic; Susan Wood, PhD, former director of FDA's Office of Women's Health; and Josh Sharfstein, a licensed pediatrician and the commissioner of Baltimore's public health department (along with being former staffer to Oversight...
November 10th, 2008
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