There is most certainly a better way to handle medical device approvals in the US. That was the consensus of testimony to the US House of Representatives Committee on Oversight and Government Reform hearing June 2. The hearing, titled ‘FDA Medical Device Approval: Is There A Better Way?’ elicited some new suggestions and reiterated many of the findings of recent studies. Even CDRH’s Jeffrey Shuren acknowledged the need for change, highlighting the agency’s recent steps to make improvements. Shuren, however, had his own harsh criticisms of industry and its role in the agency’s problems.
Industry and VC representatives, however, presented some concrete steps the agency should take to restore the balance of risk versus benefit when assessing medical devices for approval. The focus of the hearing was to continue to examine new ways to improve the process. Jack W. Lasersohn, general partner of the Vertical Group, Summit, NJ, noted that the US is losing its competitive lead in medical innovation, and will continue to do so unless lawmakers, regulators, and the private sector work together to bring the FDA’s risk-benefit analysis back into balance. FDA’s shift in culture also came under fire, and David L. Gollaher, PhD, president and CEO of the California Healthcare Institute (CHI) in La Jolla, CA, suggested that the elimination of “moving goalposts” and fixing other internal issues must be at the heart of change at the agency.
Prince George’s Hospital Center (PGHC)has selected the RF Surgical Detection System for use in all its surgical suites. The system, based on radio-frequency (RF) detection technology, is designed to identify and prevent retained surgical items (RSI) from remaining inside a patient following surgery. As an adjunct to the standard practice of manual counting, the system is being used to enhance patient safety in all the hospital’s operating rooms. Since adoption, the hospital reports there have been zero incidents. According to RF Surgical Systems, while manual counting procedures remain a standard-of-care in preventing retained surgical objects, the ability to detect surgical materials immediately and verify counting, provides assurance in reducing and eliminating costly errors and improves patient safety.
High Resolution Vision System for Medical Device Applications
The 5 megapixel In-Sight 5605 vision system combines industrially rugged hardware and best-in-class vision tools with a high resolution imager for the ultimate standalone vision system. The In-Sight 5605 system is ideal for high accuracy defect detection, gauging and ID reading applications. It's equipped with a full library of proven Cognex vision tools through the easy to use In-Sight Explorer software. Tools include code reading, OCR, inspection, measurement and color tools plus, PatMax®, the industry standard for part location technology.
Covidien has received a 2011 Annual Scientific Award from the Society of Critical Care Medicine (SCCM)for its abstract presentation, “The Impact of Obesity and Sleep Disordered Breathing on Postoperative Pulmonary Complications.” The study was one of the first to examine the relative significance of obesity and sleep-disordered breathing (SDB) on the development of postoperative pulmonary complications (PPCs). According to Covidien, the study showed that these two common, frequently comorbid conditions are independently associated with increased rates of PPCs in adult surgical patients receiving parenteral opioids. In addition, the study revealed that PPCs result in significantly increased mortality and more than double a patient’s length of stay and total costs. “We are delighted that SCCM has chosen to recognize our abstract, which highlights the considerable hospital burden of PPCs–a serious and costly occurrence in high-risk patient populations,” says Mary Erslon, director, Healthcare Economics, Respiratory and Monitoring Solutions for Covidien, and one of the study authors. “We believe our research provides further evidence of the need to adopt strategies that can help clinicians better identify at-risk patients for whom appropriate interventions, such as continuous monitoring, could avert the development of PPCs. Such strategies may also yield greater savings for hospitals.”
High-demand outsourcing needs have stretched medical manufacturing to nearly every corner of the globe. To serve its growing needs, global precision molder and contract manufacturer GW Plastics , Bethel, VT, is opening a medical manufacturing facility in Cartago, Costa Rica. Located in the Cartago-Techno Park Free Trade Zone less than 20 miles southeast of San Jose, GW Plastics’ operations that serve healthcare OEMs in the region will first be housed in a 10,000 sq ft facility owned by Corprosemm Corp, Cartago, Costa Rica. Production in the 10,000-sq-ft plant for injection molding and ISO Class 8 cleanroom assembly will begin this summer. Early next year, however, GW plans to expand to a 33,000-sq-ft facility that is currently under construction. Drawing on GW’s experience in meeting global outsourcing needs of healthcare product manufacturers and Corprosemm’s expertise in injection molding and contract manufacturing, the partnership developing between the two companies is shaping up to more effectively support customers in Latin America, as well as around the world.
A new technique in radio-frequency (RF) plastics welding enables manufacturers of medical bags and pouches to obtain the clarity, elasticity, and performance characteristics of medical elastomers, providing an alternative to PVC, thermoplastic polyurethane, and natural rubber latex. Developed by Genesis Plastics Welding, Indianapolis, and based on elastomer technologies from Teknor Apex, Pawtucket, RI, the ecoGenesis RF plastics welding process can produce such products as fluid drainage and storage bags from Teknor Apex’s Medalist elastomer–based film. Conventional RF plastics welding works well with such polymers as PVC and TPU; however, such welding cannot be used to bond low dielectric loss materials, such as Medalist elastomers. And alternative heat-sealing methods are limited to straight-line bonds. Using ecoGenesis, in contrast, can produce strong, permanent bonds with Medalist elastomers, polypropylene, and similar polymers in a range of designs that require complex patterns to be welded in one sequence.
Developed as a foundation for mass personalization in the orthopedic and CMF markets, engineering software can be used as an alternative to complex and time-consuming methods for processing medical imaging data. Dubbed 3-matic anatomical CAD by maker Materialise Group, Leuven, Belgium, the software can perform design operations directly on anatomical geometries, allowing for the design of patient-specific implants or surgical guides. Traditionally, medical imaging data, such as CT or MRI scans, are segmented to create accurate, 3-D models realistic for patient needs. These models, however, are generated in the STL file format, which is not compatible with CAD software. Some programs can import the anatomical STL files, but design operations can be performed on them. In order to counter these limitations and combine accurate anatomical data with CAD, the company has developed an anatomical reverse engineering module for its 3-matic product suite.
An interconnect products supplier is extending its offerings to include miniature models that are nearly 30% smaller in size but maintain 5 signal contacts rated at 1A each with a dielectric withstanding voltage rating of 750V. This miniature connector is an extension of the circular push-button D series connector design from Hypertronics Corp, Hudson, MA. Designed to meet increased functionality requirements of more advanced systems, the mini D series can be used in medical equipment such as monitors, therapeutic devices, imaging, and invasive probes. In addition to maintaining the high signal reliability in a smaller 0.3mm pin size, the miniature Hypertac hyperboloid contact offers high cycle life, low contact resistance, low insertion and extraction force, as well as, resistance to shock and vibration.
Machine Design's WORLD'S SMARTEST DESIGN ENGINEER The 2nd season has begun! Players from across the globe are still competing for fun, education, prizes and the ultimate bragging rights. Thanks to our sponsors for their support of the exciting online opportunity for engineers! Play Now!
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See How 3D Printing Helped in the Medical Cure for Club Feet in Children Sponsored by: Objet Date: June 16, 2011 Time: 2:00pm ET/11:00am PT
Dr. Mike North, host of the TV program Prototype This, and Miracle Feet, a non-profit organization providing medical treatment for kids in developing countries, used a Connex 3D Printer from Objet Geometries to build prototypes for a new corrective brace to treat children with clubfoot. Rapid prototyping with the Connex 3D Printer played a big role in developing the optimal brace design. There are currently 1 million untreated cases of clubfoot in the world -- 175,000 new cases a year -- with limited affordable solutions.
How to Quantifiably Confirm Cure of Light Cure Adhesives Sponsored by: Henkel Date: June 23, 2011 Time: 2:00pm ET/11:00am PT
A major challenge for OEM’s, especially medical device manufacturers using light cure adhesives, is the ability to easily verify an adhesive’s degree of cure, and thus, speed production processes while improving overall quality. Even the most conscientious manufacturer can experience incomplete cure if an inappropriate or degraded light source generates insufficient irradiance to complete cure, or if rapid processing speeds result in insufficient light exposure. While the adhesive may appear solidified, without time consuming offline verification methods involving destructive physical testing or lab analysis, manufacturers have had no method to quickly and conclusively confirm the degree of cure. It is important to have a simple in-line process that can decrease the resources dedicated to cure verification and that can improve overall quality and production rates for manufacturers. Manufacturers require technology that is ideally suited for assembly processes where high quality and low risk of field failure is desired. It is also essential for medical device manufacturers to use adhesives that meet strict ISO-10993 biocompatibility requirements.
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
Lowell: Precision Medical Device Component Manufacturing Unmatched development support and manufacturing for orthopaedic and cardiovascular implants. Devices include spine, trauma, extremity, MCS, valve repair, and vascular. Swiss turning, multi-axis milling, EDM, and clean room. ISO 9001:2000 and 13485:2003. www.lowellinc.com
What the heck is a hexa-kaleidocycle? It's Protogami, a 3-dimensional folding object that showcases the interaction of materials and surface finishes – the newest, interactive design aid from Proto Labs. Broaden your knowledge of surface finishes, materials and design techniques by requesting one today. You'll learn, you’ll be endlessly amused, and you just might be inspired to come up with the next big thing. To get yours, register here.
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/
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The 5 megapixel In-Sight 5605 vision system combines industrially rugged hardware and best-in-class vision tools with a high resolution imager for the ultimate standalone vision system. The In-Sight 5605 system is ideal for high accuracy defect detection, gauging and ID reading applications. It's equipped with a full library of proven Cognex vision tools through the easy to use In-Sight Explorer software. Tools include code reading, OCR, inspection, measurement and color tools plus, PatMax®, the industry standard for part location technology.
Also, please download our first 
