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 By Sherrie Conroy, Director of Content
Big changes are afoot for the selection of healthcare products and services, and with individuals about to player a bigger role in that process, social media will be front and center. That prediction was made Don Gerhardt, chairman of start-up accelerator company, Tri-Med LLC, and former president of LifeScience Alley. He spoke at last month's Medical Silicone Conference in Minneapolis. "If you’re going to be in the game, be in the game. With what's happening to us now, going to have to be in the game to survive it," he said. "As you think about your company and those you are supplying, think about how it's going to be marketed into the future." With that, Gerhardt said that the "singular most important thing that is happening right now" is something that will result from healthcare reform. In the future healthcare landscape, state exchanges will allow for individuals to get health insurance, putting much more power into the hand of individuals. That pool of patients, he said, will be demanding the best possible healthcare options and they will turn to social media for information. So, for medical device companies, Gerhardt said that social media is not just a fad. "Soon patients will come into their doctor's office and say ‘I am an insured patient and here’s what I want’ and they will have [the product] on their iPhone. It will be their policy and they will know what they want."
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CDRH has proposed implementation of an online repository of medical device labeling, but the idea is not faring well with device makers. Although FDA says the public database, which includes making device photographs available, would not disclose proprietary information, making medical device labeling broadly in such a repository may inadvertently lead to public confusion, says Jeff Secunda, vice president, technology and regulatory affairs, for AdvaMed. Secunda points out that many device labels contain technical or complex information intended for hospitals or practitioners and may not be clearly understandable to the lay audience. CDRH says the database might be similar to the labeling repository specific to drugs that is already available through DailyMed on the National Library of Medicine’s website. The repository could eventually cover all classes of devices and could facilitate patient access to information on what types of devices are available for their medical condition and how the devices could be used. The agency says such a repository could also assist healthcare professionals access labeling that may not always accompany a medical device.
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Responding to the challenges hospitals face in the changing healthcare environment, as well as the increasing importance of the hospital administrator as a decision maker in device selection, Medtronic has opted to combine its US cardiac and vascular group sales functions into a single cross‑divisional sales organization. The change is effective at the start of Medtronic’s fiscal year, May 1, 2011. David Roberts, formerly vice president of sales for the Cardiac Rhythm Disease Management business at Medtronic, assumes the leadership of this new 2700 person organization as national vice president of cardiac and vascular group sales. Unique in the medical device industry, the Cardiac and Vascular Group of businesses at Medtronic operate across 15 cardiovascular market segments. According to the company, it maintains leading market share positions in nearly all of them, noting that its cardiac and vascular group of businesses have nearly three times the depth and breadth of its nearest competitors. Cardiac and vascular focused hospital administrators are typically responsible for making device selections across the full cardiovascular spectrum.
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Greater healthcare expenditure supported by robust economic growth will lead to nearly 13% annual growth in the market for pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices in China, according to Millennium Research Group (MRG). The market will nearly double from a 2009 total of under $330 million to $650 million in 2015. While an aging population, increased risk factors for cardiac arrhythmias and heart failure and general economic growth contribute to the growth, the research firm says a large part of the increased consumption will be driven by increased healthcare coverage in China. The Chinese government has committed to investing more than $100 billion in healthcare with the goal of providing coverage to 90% of the population by 2011. This increased healthcare spending provides greater funding for procedures, although actual reimbursement varies regionally.
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Designed to offer engineers a greater range of options in fluid and air handling system components, a line of sanitary pipes and accessories for use in medical applications has been expanded. Providing compliance with various clean room and sanitary standards, the stainless steel sanitary pipes and associated products from Misumi USA, Inc., Schaumburg, IL, are configurable to user specifications. The line includes more than 100 different components, such as standard and welded low-neck pipes, standard and branched welded pipes, small diameter pipes, and welded branched types with selectable ends. The newest addition to the line is a one-touch clamp designed to reduce time needed to attach and detach the clamp for easier installation, operation, and maintenance. A lever provides fixed tightening torque and enables secure attachment without damaging the gasket. Cross-threading was eliminated from the design in order to provide greater durability compared with other screw tightening products. The lack of friction associated with cross-threaded designs also results in less metal powder being produced in the product’s environment.
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A V-lock power cord retaining system that latches into IEC connectors and power entry modules is designed to protect against disconnection of power. Suitable for 10A and 16A appliance couplers and power entry modules, the power cord from Schurter Inc., Santa Rosa, CA, can latch into a notched inlet or outlet to prevent accidental disconnection of the power from the equipment. The power cord’s yellow catch mechanism can be easily released by depressing its lever. Unlike wire bail or clamp accessories, the cord retaining system does not require additional hardware to install the system, which means less required material and installation time. In addition to the mating V-lock cord sets, the company offers standard inlets, outlets, power entry modules, and a variety of country-specific plugs.
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Offered as an alternative to traditional metal and plastic electrically conductive parts, a direct printing process can apply patterned conductive and dielectric thick film coatings onto disposable medical device components made of polyphenylsulfone (PPSU) resin. Micropen Technologies Corp., Alpharetta, GA, paired its Micropenning direct printing process with the Radel PPSU resin from Solvay Advanced Polymers, Brussels, in order to create a disposable component for a spinal therapy system that offered high electrical and mechanical reliability. After testing a range of materials, the PPSU demonstrated resistance to chemical abuse and high heat as well as provided secure film adhesion and biocompatibility. These traits are essential for bonding with the printing process and creating the quality disposable electrode. The direct printing process combines precision motion control with the ability to dispense materials, such as thick film polymeric inks, in a designed pattern with accuracy for widths down to 50µm. This process is also suited for medical devices with radiopaque markers and drug dosing features.
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Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
www.bokers.com/mee
Class 100 and 10,000 Clean Room Assembly of Precision Parts
Lowell assembles and packages components in Class 100 (ISO Class 5) clean room and Class 10,000 (ISO Class 7) assembly area. Capabilities: precision assembly under magnification, cleaning, heat sealing, labeling, vacuum packaging. ISO 9001:2000 and 13485:2003.
www.lowellinc.com/medical.php
Design Cube from Protomold
Our Design Cube illustrates important considerations when designing plastic injection molded parts. It showcases a range of available surface finishes and examples of bosses, gussets, and ribs. It also demonstrates the impact on part quality of overly thick or thin sections, as well as ways to incorporate holes and their potential effect on resin flow. Register today and get yours free
Thomas Division
Thomas provides OEM pump and compressor solutions for medical applications with oil-less technology offerings including WOB-L® and articulated piston, diaphragm, rotary, linear, and liquid pumps.
www.gd-thomas.com/
Norgren Life Science
Norgren Life Science has the engineering capabilities to solve all of your precision fluidic pumping and control needs. For our customers this means superior products, higher performance, lower cost of ownership, and increased sales and market share. By combining the technologies of laminate manifolds, miniature gas and liquid handling valves, pumps and syringes, Norgren Life Science is unrivaled in our ability to deliver Engineering Advantage.
www.kloehn.com
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