LEAD STORIES
The FDA recently released final guidance addressing key issues in the agency’s 510(k) clearance program, describing in detail the critical decision points in the 510(k) review process.
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Industry Leaders Address Revival Of U.S. Device InnovationRecently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.
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Google’s Newest Science Project: Defining Perfect Human HealthGoogle has launched a project focused on studying and analyzing the human body in greater detail than ever before by comprehensively cataloging genetic and molecular information. The ultimate goal of the project, which has been dubbed Baseline Study, is to map out a clear picture of what a perfectly healthy human body would look like.
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St. Jude Medical To Cut 270 Jobs In CaliforniaSt. Jude Medical is laying off up to 270 workers at its Sylmar, CA facility as part of a streamlining plan first announced by the company earlier this year.
INDUSTRY PERSPECTIVES
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An Introduction To Human Factors Engineering For Medical Device DevelopmentI hope by now the overwhelming majority of medical device manufacturers have at least heard of human factors. If you are reading this and are unfamiliar with human factors or usability, I fear that you may learn about it the hard way — a "wakeup call" from the FDA in response to your 510(k) submission requiring human factors and usability testing to be performed. But this type of testing, when executed correctly, will usually identify areas for design improvements to reduce use errors, leading to a better and more lucrative product.
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Addressing Cybersecurity Vulnerabilities As Medicine Goes MobileIs your phone compromising the security of your heath data? The mobile health, or mHealth, field is exploding with a host of new Internet-connected apps and devices. With that growth comes new concerns around data security and device safety. By Scott Sheaf, senior software engineer, Battelle
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Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device DesignsAccording to a recent PriceWaterhouseCoopers report, a major area that’s lacking in medical devices is electronic health records (EHRs), health IT, and patient data connectivity. Only about 18% of device companies integrate data into clinical workflows and EHRs, which means there’s a very nice opportunity for upstarts and savvy incumbents. Any manufacturer that focuses on device integration and data connectivity from devices into traditional health IT systems like EHRs and billing systems will have a unique offering that customers will elevate during their product selection process.
ARTICLES
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Robotic Rib Spreading Tool To Help Patients Hurt Less And Heal FasterOne advanced technology company is taking on the challenge of developing hand-held, robotic surgical instruments to help patients hurt less and heal faster. High torque maxon motors ensure jerk-free movement of the tool. By Deb Setters, maxon precision motors; By Anja Schütz, maxon motor ag
Critical Factors To Consider In Selecting Medical Grade Silicones
Applied Silicone explains the different levels of testing required for implantable silicones, and offers advice for device manufacturers on the lookout for a long-term-implantable silicone supplier.
Best Practices For Interventional Cardiovascular Medical Device Trials
Companies seeking to bring implantable cardiovascular products to market, whether they are stents, valves, pacemakers, ventricular assist devices, or other novel technologies, face several significant factors in designing and conducting clinical trials. This paper addresses the four aspects of implantable cardiovascular device clinical trials that Novella Clinical considers most critical: regulatory requirements, reimbursement strategy, clinical challenges, and vendor selection.
Design Verification Testing: The FDA Cares, You Should Too
Design Verification failures are costly, and these costs may be paid not just by development budget and schedule, but may result in rejection of submissions, warning letters, recalls, loss of market share, or in the worse cases, patient harm. Design Verification is one of the most commonly cited sections in recent warning letters issued by the FDA that include findings related to specific sections of the Design Control regulation (21 CFR 820.30).
Medical Device Development: Thinking Globally, Acting Locally
Incorporating international and emerging markets at an early stage of product development is critical for long-term success in getting to market, but also in bringing costs down by getting started smart. Understanding market opportunities from a regulatory, reimbursement, and healthcare delivery perspective, as well as understanding market fluctuations, is the first step in planning a global strategy.
FROM THE EDITOR
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Cutting Through The Remote Patient Monitoring HypeThere is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.
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Reverse Engineering A Human Heart ValveThe man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.
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Do You Make These 5 Usability Mistakes In Your Medtech Development Process?Major healthcare systems are starting to pay much closer attention to usability during the medical device procurement process. They are establishing internal human factors teams, having usability experts evaluate technologies prior to purchase, and sharing their learnings with other healthcare systems. If you fall prey to these five usability design pitfalls, your device won’t stand a chance in this new user-centric procurement environment.
PRODUCT SHOWCASE
FitQuik® Connectors
FitQuik® Connectors from Colder Products Company are high quality fittings for leak-free tubing connections. These precision molded fittings are designed to eliminate tubing leak points in medical devices, analytical instrumentation or air-driven equipment.
RF Power Amplifier for Medical EMC Compliance Testing: 75A250A
AR’s 75A250A is an RF power amplifier covering the 10 kHz to 250 MHz frequency range. It’s well suited for medical EMC compliance testing applications and offers up to 75 watts CW power when used with an RF sweep generator.
Color CMOS USB Camera: SPOT Idea
These digital microscope CMOS cameras come in 1.3, 3.0, and 5.0 megapixel resolution versions. They feature high speed readout, 12-bit image capture, Correct Color Technology for vivid color enhancement, an external trigger output, and more.
Alcotabs: Critical-Cleaning Detergent Tablets
Custom Manufactured Windows
LaCroix Optical Company produces window substrates in a wide variety of shapes and sizes using optical or filter glass, fused silica or other glass-like materials. All of our windows are produced and if necessary coated at our facility in Batesville, Arkansas.
Synthetic Fused Silica for High Optical Performance - DUV to UV/VIS Optics
Suprasil® 1 and Suprasil® 2 are high purity synthetic fused silica materials available in different grades for different applications.
Both grades are made from flame hydrolysis and are homogeneous in the primary functional direction. Both grades are made with low impurities and therefore have low absorption in the DUV, UV and Visible range.
LATEST HEADLINES
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FDA Finalizes 510(k) Substantial Equivalence GuidanceThe FDA recently released final guidance addressing key issues in the agency’s 510(k) clearance program, describing in detail the critical decision points in the 510(k) review process.
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Medtronic Buys Laser Surgery Firm For Up To $105 MillionMedtronic recently acquired Texas-based laser neurosurgery company Visualase, Inc. for up to $105 million in an all-cash transaction.
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Wearable Device Could Provide Early Detection Of Diabetes-Related ComplicationA research team in Taiwan that includes scientists from National Taiwan University Hospital and National Chiao-Tung University has created a device called a pupillometer designed to measure certain conditions in the wearer’s pupil in order to predict the early onset of a complication related to diabetes.
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European Commission Seeks Input On Safety Of Nanomaterials Used In Medical DevicesThe European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has opened public consultation on the use of nanomaterials in medical devices.
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Industry Leaders Address Revival Of U.S. Device InnovationRecently, an executive from industry giant Edwards Lifesciences addressed a congressional committee on the dwindling state of medical device innovation in the United States.
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St. Jude Medical To Cut 270 Jobs In CaliforniaSt. Jude Medical is laying off up to 270 workers at its Sylmar, CA facility as part of a streamlining plan first announced by the company earlier this year.
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SPIE Launches Neurophotonics Journal With Special Section On BRAIN InitiativeThe new peer-reviewed journal Neurophotonics, published by SPIE, the international society for optics and photonics, will facilitate further collaboration on technological advances in optogenetics, photoacoustics, spectroscopy, and more.
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Parker Hannifin Announces New Miniature Liquid Valve To Improve Fluidic DesignsThe Precision Fluidics Division of Parker Hannifin Corporation, the global leader in motion and control technologies, announces the release of its newest Diaphragm Isolation liquid Valve.
FEATURED SUPPLIERS
AR
Since 1969, AR has played a major role in the success of the automotive, medical, military, aerospace and telecom industries. The company’s products are used for a variety of critical applications including RF Test & measurement in a multitude of industries throughout the world. At AR, there’s no substitute for quality. It’s the foundation of our business and the AR value that’s recognized around the globe...