Med Device Online: Advancing human health by connecting people, organizations, and ideas in the design and development of medical devices.

Patients Use World’s First Mobile Pacemaker Station

England’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.

New Gene Therapy Could Make Electronic Pacemakers Passé
Researchers 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.
Cutting Through The Remote Patient Monitoring Hype
There 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.
Heat-Seeking Missile Tech Used For Malaria Diagnosis
Researchers at Monash University and the University of Melbourne have devised a way to use hardware from heat-seeking missiles to produce a test for early and reliable malaria diagnosis. In the project, researchers used a special infrared sensor called a focal plane array (FPA), which was originally created for use in Javelin anti-tank missiles, to seek out the presence of malaria in a blood sample. When the FPA was used in conjunction with an infrared imaging microscope to test a blood smear, it successfully detected the infrared signature from fatty acids in the malaria parasites, enabling researchers to consistently identify malaria-infested blood at early stages of infection.

Addressing Cybersecurity Vulnerabilities As Medicine Goes Mobile
Is 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
Why Data Connectivity To Traditional IT Systems And EHRs Should Be A Priority In Your Device Designs
According 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.
U.S. Orthopedic Trauma Device Market To Exceed $8 Billion By 2020
The U.S. orthopedic trauma device market consists of a variety of devices used in the treatment of fractures throughout the body. The largest of such device segments in 2013 was the plate and screw market, which will continue to remain the dominant market segment going forward. The intramedullary nail and intramedullary hip screw markets are also expected to experience high levels of growth in the same time frame. These three markets composed nearly 64% of the overall U.S. orthopedic trauma device market in 2013 and, as such, will be the main contributors to the overall market growth in the forecast period through 2020.

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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.

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.

Cutting Through The Remote Patient Monitoring Hype
There 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.
Reverse Engineering A Human Heart Valve
The 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.
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.

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.

Class A Solid State Amplifier: 150W1000

AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 150W1000 is a class A solid state amplifier which provides 1500 watts of output power from 80 to 1000 MHz. It has superior gain flatness, an exceptional noise figure, and better efficiency and harmonics than competitive products.

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products. High accuracy and exceptional repeatability results in the most reliable measurement available.

Thermal Research Camera: T650sc

FLIR’s T650sc is a battery powered, handheld thermal imaging camera ideal for applications that involve thermographic studies and temperature measurements. It covers the -40°C to 2,000°C temperature range and employs a 640 x 480 infrared microbolometer detector.

Luminox: Low-Foaming Neutral Cleaner

Low foaming for use in mechanical and spray washers. Neutral pH for non-corrosive cleaning, safe handling, and easy waste disposal. No chelation or alkalinity waste treatment problems. Concentrated for economical use. Free rinsing to eliminate interfering residues. Biodegradable and phosphate free.

PMC12 Series: Couplings

The 1/8" flow polypropylene PMC12 offers many of the same configuration options as the PMC. The polypropylene material adds greater chemical resistance for more demanding applications. PMC12 couplings are also gamma sterilizable.

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Developing Fly-Inspired, Piezoelectric Hearing Aids
Using 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.
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.
Patients Use World’s First Mobile Pacemaker Station
England’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.
Printable, Flexible, Rechargeable Batteries For Medical Devices
Imprint 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.
New FDA Curriculum To Educate Innovators On Approval Process
The 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.
New Gene Therapy Could Make Electronic Pacemakers Passé
Researchers 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.
St. Jude Announces CE Mark Approval, First Use Of New Flexible Ablation
St. Jude Medical, Inc., a global medical device company, recently announced CE Mark approval and first use of the FlexAbility Ablation Catheter, a novel ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias.
Heat-Seeking Missile Tech Used For Malaria Diagnosis
Researchers at Monash University and the University of Melbourne have devised a way to use hardware from heat-seeking missiles to produce a test for early and reliable malaria diagnosis. In the project, researchers used a special infrared sensor called a focal plane array (FPA), which was originally created for use in Javelin anti-tank missiles, to seek out the presence of malaria in a blood sample. When the FPA was used in conjunction with an infrared imaging microscope to test a blood smear, it successfully detected the infrared signature from fatty acids in the malaria parasites, enabling researchers to consistently identify malaria-infested blood at early stages of infection.