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KNF debuts Type NF1.25 high-pressure micro diaphragm pump
The KNF Type NF1.25 micro diaphragm pump offers a high-pressure solution for dosing or transferring liquids or liquid-gas mixtures at flow rates up to 300 ml/min. This small and powerful pump is engineered to operate either intermittently or continuously against pressure up to 6 barG (87 psig) over ...
(February, 2012)
Members of Congress Introduce Legislation To Close Loophole In Medical Device Approval Process
Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) announced in a press release that they have introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill closes a major loophole in the device ...
(February, 2012)
Senators Introduce Legislation to Remove Regulations Slowing Innovation for Medical Device Manufacturers
Senators Bob Casey (D-PA) and John McCain (R-AZ) announced in a press release that they have introduced legislation to remove burdensome regulations that hurt medical device manufacturers. Casey and McCain’s bill would streamline the pathway for medical device manufacturers to innovate and bri...
(February, 2012)
IRS Moves Forward with Plans to Implement Medical Device Tax
The IRS has recently released proposed regulations to implement the 2.3% medical device tax, which has been cast by critics as a "tongue depressor tax." The proposal includes exemptions for early-stage medical devices but, in general, does little to allay the concerns of the indu...
(February, 2012)
VC Funding in Medtech Lackluster in Fourth Quarter of 2011
A recent report titled "Zigzagging upward" from PricewaterhouseCoopers (PwC) found that venture capital funding for medical device and biotechnology companies grew by 21% in 2011. In all, venture capitalists invested $7.5 billion in 785 life science deals during the year. Of that...
(February, 2012)
Senators Welcome FDA Medical Device User Fee Agreement
Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), released the following statement welcoming the announcement that FDA has reached an agreement with the medical device manufacturing industry on th...
(February, 2012)
FDA, Medical Device Industry Reach Agreement in Principle on Medical Device User Fees
FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program, according to an FDA press release. The recommendations would authorize FDA to collect $595 million in ...
(February, 2012)
FDA Trends for Reusable Medical Device Reprocessing Validations
More complex devices and the rise of hospital-acquired infections are requiring manufacturers to take a second look at validation.
(February, 2012)
Inside Look—Startup Sees Need for Autism, Mental Illness Devices
Common treatments for autism include behavioral learning, occupational, physical, and speech-language therapies, as well as medications. But a dearth of medical devices aimed at treating the disorder has led parents of autistic children and people who fall on the autism spectrum themselves to create...
(January, 2012)
FDA Releases 2012 Medical Device Priorities
FDA's Center for Devices & Radiological Health has announced its strategic medical device priorities for 2012. The device center said it will focus on the following four key areas this year: implementing a total product lifecycle approach, enhancing communication and transparency, strengthening ...
(January, 2012)
Editorial: Nothing So Uncertain As Taxes
Obama calls for lowering medtech manufacturing taxes—but not the device tax  
(January, 2012)
Exclusive: Survey Finds Hospital Execs Gloomy about Coming Year
Nearly half of hospital executives expect business conditions for the U.S. hospital industry to worsen over the next 12 months, according to the most recent “Hospital Executives” survey commissioned by ITG Market Research. A total of 85% of the executives reported being “very conce...
(January, 2012)
Value Plastics’ bag-port technology improves material transfer in biopharmaceutical apps
Value Plastics recently introduced an advanced series of ports for the single-use bags used to transfer media and drug compounds in the biopharmaceutical industry. The benefits offered by the products include animal derivative-free qualification, USP Class VI certification, guaranteed heat sealing a...
(January, 2012)
Future Risks: How Biomedical Companies Navigated Turbulent Economic Times
  Future Risks and Dangers After five relatively good years, the medical device industry faces a more challenging future, with significant risks to growth and profitability. Regulation of medical devices is growing, with new certifications and testing required in the United States by...
(January, 2012)
Key Challenges: How Biomedical Companies Navigated Turbulent Economic Times
  Key Challenges to Continued Success   Lack of Focus. As a result of the ongoing acquisitions and continuing investment in R&D, many firms  struggle to continuously define and refine what they are and their core focus. There is a steady stream of spin-outs or sell-off of...
(January, 2012)
R&D and Investment: How Biomedical Companies Navigated Turbulent Economic Times
  Investment in R&D and New Products Over the past few years the way the medical devices industry assesses innovation and new technology has changed. The old dynamic of the physician as judge of value has been replaced with the government, private insurers, and consumers increasingly d...
(January, 2012)
CDRH Ombudsman Reports on Complaints
The ombudsman of FDA's Center for Devices and Radiological Health reported that it had 461 contacts with the public in 2011, up 11% from the previous year. These contacts include complaints about the FDA's medical device review process, as well as other contacts that never rise to the level of a com...
(January, 2012)
How Biomedical Companies Navigated Turbulent Economic Times
An analysis of 25 top independent firms in the biomedical device and technology industry.
(January, 2012)
Approach and Methodology: How Biomedical Companies Successfully Navigated Turbulent Economic Times
Approach and Methodology      To conduct this study, we sought out top firms in the medical device and technology sector with a primary or growing future focus on this market. Based on size, we identified the largest 25 top independent medical device makers that comprise th...
(January, 2012)
Teleflex Medical OEM’s Rod Cutter Can Reduce Operating Effort by More Than 50%
Teleflex Medical OEM recently launched a high-performance rod cutter specifically designed to handle extremely strong cobalt chromium (CoCr) and titanium rods. With proprietary shearing technology, the cutter provides consistent, clean cuts with less effort, a reduction of more than 50% in some case...
(January, 2012)
Transparent Masterbatch Colorants Meet or Exceeds ISO 10993 and USP Class VI Requirements
Transparent color concentrates for medical-grade copolyesters are certified to meet the USP Class VI testing protocol. These OnColor HC Plus masterbatch colorants complement existing certified colors for opaque resins used in medical device manufacture. Because the complete palette of standard and c...
(January, 2012)
Product Life Cycle Management Service Meets 21 CFR Part 11 Requirements
A consulting firm has developed a preconfigured product life cycle management (PLM) service that medical device companies can rapidly implement. PLM Vivo for Medical Devices features a short set-up time, a structured design control process, and a validated, production-ready software system, enabling...
(January, 2012)
Medical Plastics Molding Company Offers Rapid Prototyping
A manufacturer of plastic molded medical device components provides concept review, rapid prototype design, material selection, component assembly and packaging, and sterilization-management services. Supported by process validation and reporting, the firm supplies OEMs with thermoplastic and thermo...
(January, 2012)
Company Offers Nitinol and Medical Alloys, Assistance with Product Customization
A nitinol melting facility is dedicated to producing materials for the medical device industry, including custom titanium and other high-performance alloys as well as the shape-memory material. Employing a special custom melt process, the production plant enables the metals supplier to provide more ...
(January, 2012)
Laser Ablation Machine Handles Surfaces with Arbitrary Geometry
A five-axis laser ablation machine is designed for 3-D machining. The LaserSmart is suited for extra-fine 3-D laser machining of super-hard materials, such as polycrystalline diamond (PCD) and cubic boron nitride (CBN).The machine can handle surfaces with an arbitrary geometry and can be used to app...
(January, 2012)