FEATURED EDITORIAL

TAVR: Will It Render Open-Heart Valve Replacement Surgery Obsolete?
TAVR: Will It Render Open-Heart Valve Replacement Surgery Obsolete?

I spoke with Craig Thompson, MD, SVP/CMO of Boston Scientific’s Interventional Cardiology unit, about TAVR costs, benefits, and market drivers, as well as Boston Scientific’s Lotus valve system.

  • Why Overmolding Works Well For Human-Factors Engineering
    Why Overmolding Works Well For Human-Factors Engineering

    Factors driving the adoption of human factors engineering include market demand for intuitive products, the world’s growing, aging population, mass customization of products, and greater patient engagement. User preference now is almost as important as clinical efficacy, as customer feedback and performance metrics affect how hospitals and other providers are compensated by insurance companies and Medicare.

  • 4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
    4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

    After countless hours putting together your 510(k) submission, the last thing you  expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.

  • 6 Ways Medtech Can Give Back To The Community
    6 Ways Medtech Can Give Back To The Community

    As part of the outsourcing and offshoring community, we collectively take a lot from local communities, and often forget what enables us to reap such financial and strategic benefits. Giving back to the communities in which we live and work should be a cornerstone of the outsourcing/offshoring relationship.

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INDUSTRY INSIGHTS

  • Barcoding Standards And The Search For A UDI “Easy Button”
    Barcoding Standards And The Search For A UDI “Easy Button”

    As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”  

Time To Innovate: Ensuring A Future Without The Medical Device Tax

The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.

How To Select A Pump For Surgical Ablation Applications

Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.

5 Antimicrobial-Related Trends In Medical Device Design

Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.

7 Considerations For More Effective Medical Device Labeling And Overlays

Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.

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SOLUTIONS

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Medical Silicone Processes Medical Silicone Processes

FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.

Pressure Relief Valves (For Plastic) Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Medical Micromolding Medical Micromolding

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Medtronic’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

Optical Component Prototypes Using Rapid Injection Molding Process Optical Component Prototypes Using Rapid Injection Molding Process

Protomold’s rapid injection molding process is a very useful option for prototyping lenses that need to be tested for fit and structural integrity in optical systems. Optical component prototypes produced using the rapid injection molding process can cost up to 90% less than parts produced with traditional tooling methods.

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FEATURED SUPPLIERS

Medtronic Medtronic

As a global leader in medical technology, services and solutions, Medtronic improves the lives and health of millions of people each year. We use our deep clinical, therapeutic, and economic expertise to address the complex challenges faced by healthcare systems today.

FMI, Inc. FMI, Inc.

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • FDA Approves Medtronic's “Artificial Pancreas” For Type 1 Diabetes
    FDA Approves Medtronic's “Artificial Pancreas” For Type 1 Diabetes

    The U.S. Food and Drug Administration (FDA) has approved Medtronic's "artificial pancreas" device, the MiniMed 670G, the first hybrid closed loop system that automatically monitors blood glucose and provides appropriate insulin doses with minimal user input.

  •  “Smart” Contact Lens Uses Optical Biosensing To Detect Glucose
    “Smart” Contact Lens Uses Optical Biosensing To Detect Glucose

    Scientists at the University of Houston (UH) have developed a new approach to glucose-sensing contact lenses by integrating an optical sensor. Though the correlation between glucose levels in tear samples and traditional blood samples is not yet established, the researchers said that their “smart” contact lens prototype demonstrates the versatility of their biosensing technology and a possible non-invasive alternative to existing glucose monitors.

  • FDA Clears Abbott's Needle-Free CGM For Professional Use
    FDA Clears Abbott's Needle-Free CGM For Professional Use

    FDA has approved Abbott’s Freestyle Libre Pro System for professional continuous glucose monitoring (CGM), which provides clinicians with 14 days’ worth of patient data so they can make more informed clinical decisions regarding diabetes management. 

  • FDA Clears Medtronic's TrailBlazer Guidewire Angled Support Catheter
    FDA Clears Medtronic's TrailBlazer Guidewire Angled Support Catheter

    Medtronic says the U.S. Food and Drug Administration (FDA) has cleared the company's TrailBlazer angled support catheter, which is used in endovascular procedures to support a guidewire and deliver solutions and diagnostic agents as part of the treatment of peripheral artery disease (PAD).

  • Edwards’ New Aortic Valve Geains CE Mark Approval

    Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it received CE Mark for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. Incorporating the advanced RESILIA tissue, the INSPIRIS valve leverages features of the trusted PERIMOUNT Magna Ease valve and includes the proprietary VFit technology, which is designed for potential future valve-in-valve procedures.

  • Medical Device Research Hub CÚRAM Opens In Ireland
    Medical Device Research Hub CÚRAM Opens In Ireland

    Galway, Ireland further solidifies its position as a global center for medical technology as it opens CÚRAM, the Centre for Research in Medical Devices, based at NUI Galway. The facility will provide Irish and foreign scientists and entrepreneurs support in developing basic research ideas — in glycoscience, biomaterials science, regenerative medicine and tissue engineering, drug delivery, and medical device design — into commercially viable clinical applications.

  • Boston Scientific Buys EndoChoice for $210M, Expands GI Business
    Boston Scientific Buys EndoChoice for $210M, Expands GI Business

    Boston Scientific has announced a $210 million deal to acquire EndoChoice Holdings, an Atlanta-based medtech specializing in endoscopic imaging systems, single-use devices, and infection control products. 

  • GE Healthcare Launches Its First Healthcare Accelerator For Emerging Markets
    GE Healthcare Launches Its First Healthcare Accelerator For Emerging Markets

    GE Healthcare is earmarking $50 million to fund five.eight, its first healthcare accelerator, which will support startups that develop promising, low-cost medtech technologies specifically designed for emerging markets.

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UPCOMING TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
Medical Device Recalls – Keys To Implementing A Successful Approach October 27, 2016
1pm-2:30pm EDT, Online Training
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