LEAD STORIES
I 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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Printable, Flexible, Rechargeable Batteries For Medical DevicesImprint Energy, a California-based startup, has developed ultra-thin, flexible, zinc-polymer rechargeable batteries that could have a significant impact on the field of wearable medical devices.
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New FDA Curriculum To Educate Innovators On Approval ProcessThe FDA is hoping to help industry better navigate the labyrinth of its medical device regulatory approval process by offering a free, university-level regulatory training program.
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New Gene Therapy Could Make Electronic Pacemakers PasséResearchers at the Cedars-Sinai Heart Institute in Los Angeles have developed a minimally invasive gene transplant procedure that they say could one day provide an alternative to implantable electronic pacemakers.
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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Critical Factors To Consider In Selecting Medical Grade SiliconesApplied 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.
Managing Change Control To Comply With FDA And EU Regulations
When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.
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.
Alcotabs: Critical-Cleaning Detergent Tablets
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.
Imaging Couplers
These imaging couplers are designed to connect to an endoscope in order to provide high resolution and high definition images. This is particular useful in medical procedures like surgery, gastrointestinal and respiratory tract observation, and more.
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.
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.
LATEST HEADLINES
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Developing Fly-Inspired, Piezoelectric Hearing AidsUsing a fly as inspiration, researchers at the University of Texas at Austin (UT) have created a miniature device that they say could lead to the development of hypersensitive hearing aids. The research team focused on the Ormia ochracea fly, which has a highly sophisticated hearing system. Contrary to other animals, insects generally cannot pinpoint sound sources because sound waves essentially hit both of their ears at the same time. The Ormia ochracea fly’s hearing system is different, as it contains tiny, teeter-totter-like mechanisms within the ear system that enable the fly to pinpoint sound sources within two degrees.
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Apple-IBM Alliance: How Will It Affect Healthcare?Apple and IBM recently announced a pact to develop enterprise solutions centered on the iOS operating system — uniting the complementary strengths of the two erstwhile rivals that could impact many industries, including healthcare.
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Patients Use World’s First Mobile Pacemaker StationEngland’s National Health Service (NHS) has launched its first mobile pacemaker station in the town of Southampton. The station has been designed to allow patients with pacemakers to conduct regular check-ups without having to visit a doctor.
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Printable, Flexible, Rechargeable Batteries For Medical DevicesImprint Energy, a California-based startup, has developed ultra-thin, flexible, zinc-polymer rechargeable batteries that could have a significant impact on the field of wearable medical devices.
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New Device Costing Just £10 Detects Deadly Lung DiseaseA scientist from the University of Exeter has developed a simple, cheap and highly accurate device for diagnosing a frequently fatal lung disease which attacks immune deficient individuals such as cancer patients and bone marrow transplant recipients.
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Philips To Expand Technology Platforms For Near Patient Diagnostic Testing With Acquisition Of UnisensorRoyal Philips recently announced that it has signed an agreement to acquire Unisensor, an innovator in the field of optical analysis of fluids for diagnostic applications in health care, as well as other industries.
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New FDA Curriculum To Educate Innovators On Approval ProcessThe FDA is hoping to help industry better navigate the labyrinth of its medical device regulatory approval process by offering a free, university-level regulatory training program.
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New Gene Therapy Could Make Electronic Pacemakers PasséResearchers at the Cedars-Sinai Heart Institute in Los Angeles have developed a minimally invasive gene transplant procedure that they say could one day provide an alternative to implantable electronic pacemakers.
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...