The US medical device industry is increasingly focusing on how to reinvigorate innovation, and US companies are seeking new entrepreneurial models, both culturally and corporately, as they grapple with how to make that happen within their own organizations. It can be done, says entrepreneur Josh Makower, MD. Makower spoke candidly about innovation in a Q&A with Monali Patel at Frost & Sullivan’s Medical Devices, 2011, conference in March.
Makower was part of a group that once started a program at Pfizer called the Strategic Innovation Group, which he says was designed to support an entrepreneurial approach to innovation within the large company. “That exercise was the basis for what we do at Biodesign at Stanford and what I do for a career now,” he said. “We were successful in identifying opportunities. Where we failed was that the organization had a difficult time putting substantial resources behind the project.”
Under pressure to finds ways to foster innovation, FDA launched the Innovation Pathway, a priority review program for new, breakthrough medical devices. The first submission to be reviewed is a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
Sharon Segal, vice president of technology and regulatory affairs for the AdvaMed , said, “AdvaMed appreciates FDA providing the opportunity for all stakeholders to offer input on its Innovation Initiative. We also commend the agency for its recognition that an efficient and predictable regulatory system is important for improved patient care and for America’s world-leading role in medical innovation."
High Resolution Vision System for High Accuracy Gauging, Defect Detection and ID Reading
The new 5 MP (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 and gauging applications and allows a larger field of view making it easier for the vision tools to accurately find the features of interest on even large size parts, products, and packages. Download the In-Sight product guide now to learn more.
Espicom Business Intelligence has published a company intelligence report and its Healthymagination initiative. According to the report, GE’s growth strategy for its healthcare division centers around its Healthymagination initiative under which it has committed $6 billion to enable better health focusing on cost, quality, and access. It generated revenues of $16.9 billion in 2010, up 5.5% on the previous year and representing 11% of its parent company’s total sales.
The report says the company is also drawing on the capabilities of several other GE subsidiaries to deliver better care to more people by reducing the cost of procedures and processes with GE technologies and services, increasing people’s access to services and technologies essential for health, and improving quality and efficiency for customers through simplifying and refining healthcare procedures and standards of care. It is also investing in content to drive healthcare IT and health in rural and underserved areas.
Discover how advances in stereolithography technology and resins can speed up your product development. That’s the focus of a free webinar hosted by Omnexus and DSM Somos on April 19. The webinar will explore how advances in stereolithography technology and resin have changed the rapid manufacturing landscape. It will also look at how do these advances can help accelerate the product development cycle from months to days. The webinar will present the latest technical improvements in rapid manufacturing technology, highlighting the recent advances in stereolithography technology and resins. It will cover an introduction to stereolithography as well as how stereolithography can significantly lower product development cycle times. Case studies on prototyping, customized parts for medical, rapid manufacturing, and tooling will be presented.
A designer and manufacturer of high-performance backplanes offers its 3U six-slot OpenVPX backplane with a twisted-ring routing topology. Elma Bustronic Corp, Fremont, CA, created the new backplane in compliance with VITA 65 specifications for OpenVPX. The six-slot backplane has configurable thin pipe links for distributed gigabit Ethernet for slots one through five, and two fat pipes for rear I/O. Any or all of the P1 thin pipes in slots one through five assigned to the control channel star can be reconfigured as rear I/O by removing zero ohm SMT shunts.
Designed for medical and electronic component-assembly applications, a line of servo-controlled ultrasonic welding systems has been expanded to include small and large press models. The expanded iQ welding line is from Dukane Corp.’s Ultrasonics Div , St. Charles, IL, which supplies various welders for OEM and plastic-assembly operations, including ultrasonic, vibration, spin, thermal press, and hot-plate models. Boasting a data processing rate of 0.5 ms, the systems also enable validation of servo motion and speed control. The new high-frequency welders can function at 30, 40, and 50 kHz to handle such small medical components as valves, ports, filters, and implant parts. Capable of operating from 600 to 1800 W, the small system is suited for high-speed throughput and automation applications.
Flame-retardant and free of Halogen, Phthalate, Bromine and PVC…Technical Cable Engineered to Exceed
Northwire Technical Cable—innovative solutions provider—designs and manufactures medical and retractile cables and assemblies. Quotes in 24 hours or less. RoHS and REACH compliant, UL-rated, CSA-recognized and FDA-approved options available in 5 days or fewer. No minimums. Over-mold assembly compatible, stocking programs, custom colors, private labeling, lot traceability and more. Finite element analysis and rapid prototyping available. Northwire's experts help navigate national and international standards, agency compliance, environmental regulations, electrical, ergonomic and aesthetic requirements. + 1 715.294.2121
Suited for medical imaging devices, test equipment, and high-end communications applications, a processor core features an integrated graphics engine and Intel Turbo Boost Technology 2.0, which helps increase the operating frequency of processor cores beyond baseline levels. The PCOM-B217VG module can exceed 3 GHz, according to real-time power and temperature measurements from supplier American Portwell Technology Inc, Fremont, CA. The increased frequency capacity is complementary to hyper-threading, which can increase the unit’s performance for multi-threaded and single-threaded applications.
Also featuring Intel’s quad-core and dual-core Core i7/i5 processors, the integrated graphics engine supports various media functions, including providing increased graphics capabilities, while reducing overall platform power requirements.
Eliminate Tubing Misconnections
The SRC connector from Colder Products Company provides medical personnel with a tubing connector that is designed to eliminate potential misconnections that can occur with luer fittings. www.colder.com/smallbore
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
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
Bishop-Wisecarver Corporation
Why did this medical company choose DualVee Motion Technology® for their body fluid analyzer equipment? Smooth motion, low noise, and reliable antifriction guidance -- read more!
Phillips Plastics Corporation®
Medical OEM projects often require more that a custom part or a vendor with limited services. Learn more about the engineering services, materials support, clean rooms, quality control, packaging, sterilization, manufacturing technologies available from Phillips Plastics.
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The new 5 MP (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 and gauging applications and allows a larger field of view making it easier for the vision tools to accurately find the features of interest on even large size parts, products, and packages. Download the In-Sight product guide now to learn more.
Northwire Technical Cable—innovative solutions provider—designs and manufactures medical and retractile cables and assemblies. Quotes in 24 hours or less. RoHS and REACH compliant, UL-rated, CSA-recognized and FDA-approved options available in 5 days or fewer. No minimums. Over-mold assembly compatible, stocking programs, custom colors, private labeling, lot traceability and more. Finite element analysis and rapid prototyping available. Northwire's experts help navigate national and international standards, agency compliance, environmental regulations, electrical, ergonomic and aesthetic requirements. + 1 715.294.2121
