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Articles from 2013 In September


Catheter Manufacturing Equipment

Microextruder

A 16-mm microextrusion system designed to process fluoropolymers for miniature medical device applications such as fine-wire jacketing for neuromodulation, microdialysis tubing, and neonatal intravenous (IV) catheter tubing is available from American Kuhne Inc. For producing such devices as microtubes with x-ray striping, the extruder is capable of processing high-performance ETFE, PFA, and FEP at such low volumes as 3.4 g/min. A chief benefit offered by an extruder of this size for microminiature component applications, besides the minimal output rate, is the short residence time in the barrel, which helps to minimize thermal degradation of the extrusion material. The machine manufacturer supplies a range of integrated precision microextrusion equipment, including modular microextruders, touch screen control systems, spiral-flow crossheads, automatic concentricity adjustment technology, heated cooling tanks, and servo-driven puller-cutter systems.
American Kuhne Inc.
Ashaway, RI

Balloon-bonding system

The Model 620B multiwelder from Beahm Designs Inc. is used to perform catheter shaft or balloon bonding. Providing an alternative to laser welding technology, the system combines multiple process steps and stabilizes the process of bonding thermoplastic components, essentially eliminating the risk of operator error. To create smooth, seamless transitions along a shaft, traditional catheter tube-bonding methods require the use of a hot-air station for preshrinking and a radial compression bonder to create the tube joint. In contrast, this tube-bonding system has the ability to preshrink the sleeve and then bond or fuse two components via an automated single-cycle sequence. Its split-die technology allows the generation of high-precision bonds in a range of widths and diameters, including narrow weld profiles of the sort typically produced with lasers. As a result, the system fulfills the requirements of demanding applications such as short balloon bonds and ultrasmooth lap joints.
Beahm Designs Inc.
Los Gatos, CA

Custom pad printing systems

Engineers at Pad Print Machinery of Vermont can work closely with medical device manufacturers to create fully automated in-line pad printing systems. They accomplished this task when the company integrated its KE13 printer into an established production line to off-load multiple catheters directly from the line onto its own conveyor, print all six parts of the catheter simultaneously, and then unload them onto the client's existing off-load conveyor. To minimize total system footprint, the designers of the custom application added a 90° rotational device to the pad bar to allow the tubular parts to be printed perpendicularly to the machine. The servo controls and Windows-based operating system on the printers belonging to the series involved in this application make it possible for job parameters to be stored and instantly recalled. These parameters include all print phases plus print and cliché pauses. The stored values enable the operator to quickly change from tubing of one diameter to that of another.
Pad Print Machinery of Vermont
East Dorset, VT

Automated inspection systems

NSX-series macrodefect inspection systems from Rudolph Technologies Inc., a provider of process characterization equipment and software, are designed for critical device manufacturing applications in which 100% quality assurance inspection is normally required. When performing fast, repeatable inspections of the pressure sensors used in catheter-balloon inflation devices, the automated systems are engineered to detect potentially yield-inhibiting defects 0.5 µm and larger in size. They are suited for quickly and accurately checking components for defects at any stage of the production process.
Rudolph Technologies Inc.
Flanders, NJ

Leak and flow tester

The customizable, pneumatically controlled Optima vT multisensor leak and flow tester can be used to perform vacuum-decay tests, pressure-decay leak tests, differential-pressure-decay leak tests, and back-pressure and differential-pressure mass-flow leak detection. In addition, the system performs tests of upstream and downstream cracking pressure, pressure-rise tests, burst tests, laminar-flow tests, force-decay tests, and occlusion tests. It enables users to tackle such difficult applications as multilumen catheter testing. At the heart of the system from Uson L.P. is the manufacturer's second-generation test control unit, which offers flexibility through a choice of one or two test channels with as many as four high-resolution sensors per channel. Thus, either four or eight independent cavities can be tested simultaneously. The tester can be configured for high-throughput simultaneous testing using all sensor inputs or for sequential testing in a variety of modalities. It features a full-color touch screen display with intuitive user interface, built-in automated calculators, and data-handling, storage, and enclosure options.
Uson L.P.
Houston

Linear assembly system

The LS 280 linear palletized assembly system available from Weiss North America Inc. can be the versatile foundation of plant assembly systems customized for the manufacture of a variety of medical devices, such as catheters, hypodermic needles, inhalers, diagnostic pens, and blood-sugar test kits. The system features a robust design, with workpiece carriers being transported and interlocked on a cylindrical cam that combines positioning precision of ±0.03 mm in the x- and y-axes and ±0.06 mm in the z-axis with stable interlocks. Pallet indexing times of half a second are typical. One of the company's straight-line assembly systems based on this modular transfer concept is 12 m in length and incorporates 15 processing stations and 42 circulating pallets. System modules are delivered to assembly line creators complete with a solid-steel machine base so that customers do not have to build a frame. In addition, the footprint is designed to accommodate assembly cell control cabinets and a master programmable logic controller.
Weiss North America Inc.
Willoughby, OH

Modeling software for microcatheter development

Roth Technologies LLC produces radiopacity-modeling software for the development and optimization of catheter marker bands and radiopaque polymer formulations. The software predicts marker band visibility (RP Index) under fluoroscopy. Its algorithms take into account part material, geometry, and tolerances to compute the RP index mean, minimum, and maximum values for a design based on expected statistical variations and process capability. Compatible with Windows XP and Windows 7 operating systems, the software can also be integrated with Microsoft Excel. It includes an extensive library of marker band materials commonly used in the medical device industry. Stored in a MySQL server that is accessed via an Internet connection, the managed database can be configured and customized at the customer level to meet specific design requirements.
Roth Technologies LLC
San Antonio, TX

The iPhone 5s mHealth-Enablers: The A7 and M7 Chips

The iPhone 5s is here with new features such as 64-bit architecture and fingerprint identity sensor. The phone also includes M7 and A7 processors that could support various new health and fitness applications. Much has been made of the A7's speed, and its ability to boost the performance of the iPhone 5s. The M7 a coprocessor designed for mobile health applications. The M7 works in tandem with the A7 to examine motion data from the phone's gyroscope, accelerometer, and compass. The M7 offloads such tasks from the central CPU, helping the iPhone 5s determine whether the users is stationary, stationary, walking, running, or travelling in a vehicle. "With new software and applications, you are going to get a whole new level of health and fitness solutions never before possible on a mobile phone, promised Phil Schiller, Apple's VP of worldwide marketing. Apple also released a statement explaining the developers could access its CoreMotion APIs that use the M7 to create a new generation of fitness and health apps.

The new processing horsepower curbs the power needed to run the phone's standard motion sensors, enabling them to run in the background as the phone is sleeping. This functionality could enable the phone to be used as an activity monitor; while apps are currently available that serve this function, their accuracy is limited and they drain the phone's battery. Incidentally, Motorola's new Moto X smartphone includes a similar processor designed to track motion.

The A7 chip, introduced
The A7 chip represents a considerable upgrade from its predecessor, the A6, which was used in the iPhone 5.

One of the first apps to take advantage of the processing horsepower is the Nike+ Move. The device tracks users' activity levels and is designed to motivate them to get more exercise.

A recent iPhone 5S teardown from our friends at iFixit reveal the backside of the device's logic board, which contains an Apple A7 APL0698 SoC, a Qualcomm MDM9615M LTE modem, and WTR1605L LTE/HSPA+/CDMA2K/TDSCDMA/EDGE/GPS transceiver. The A7's CPU does away with ARMv7 "instruction set" (ISA) (which Gizmodo explains has a 20-year foundation), replacing it with a substantially different ARMv8 design. The A7 is now the fastest smartphone chip by a variety of performance metrics. It has 40 times the CPU power of the first iPhone and is roughly twice as fast as the A6 chip that preceded it. Most of its speed boost is based on the A7's upgrade to the ARMv8 design.

A7
The A7 marks the first use of 64-bit processing in a smartphone. The CPU component of the chip is a dual-core 1.3GHz CPU known as Cyclone.
The iPhone 5s's M7 chip
iFixit did not initially locate the M7, and wondered if it was a separate IC or if its functionality was built into the A7. Chipworks.com, however, was able to locate the M7, describing it as a "NXP LPC1800 device that was buried beneath a neoprene-looking cover."
die photograph for the A7
The A7 die photo, courtesy of Chipworks.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz

Spotlight on IV Components and Connectors

Hypodermic needles

The B. Braun OEM Div. of B. Braun Medical Inc., an FDA-registered, ISO 13485-certified provider of contract manufacturing services and components for medical devices and custom kits, offers a line of bulk nonsterile hypodermic needles in a range of gauges and lengths. The needles have a smooth surface with a light silicone coating, and their sharp, tribeveled profile is designed to promote ease of penetration and minimize discomfort and pain. Their transparent luer-lock needle hubs help enhance visibility and facilitate flashback detection. Available as stand-alone components or integrated into a custom kit, the needles are color coded for easy identification. These bulk hypodermic needles are part of the manufacturer's portfolio of sterile and nonsterile syringes and sterile needles.
B. Braun OEM Div.
Bethlehem, PA

PVDF tubing connectors

Offered by Colder Products Co., the FitQuik line of quick-disconnect connectors for plastic tubing includes more than 100 options in PVDF as well as the previously existing configurations in nylon, polypropylene, and polycarbonate materials. PVDF is characterized by high levels of purity, chemical compatibility, and resistance to ultraviolet radiation. Fittings made from this material offer robustness and the ability to tolerate aggressive media and environments. Molded from Kynar 720, the PVDF fittings comply with the FDA 21 CFR 177.2510 requirements, are certified animal-free, and meet USP Class VI requirements. Designed for tubing sized from 1/16 to 3/8 in. OD and including a variety of threaded configurations, the precision-molded fittings, which are free of parting lines, are designed to ensure a secure, leak-free fit in demanding fluid-handling applications in medical diagnostics and analytical instrumentation.
Colder Products Co.
St. Paul, MN

IV-flow regulator

A device for regulating IV-fluid flow, part number 21293 from the stock OEM disposable component catalog of Qosina Corp., features an easy-turn ridged dial that facilitates accurate flow rate adjustment. Latex- and DEHP-free, the regulator is made of ivory-colored ABS and includes a clear silicone gasket. Clearly marked blue flow indicators, offering a measurement range of 5 to 250 ml/hr, help ensure a reliable infusion rate. This IV-flow regulator is designed for use with tubing that features dimensions of 0.118 in. ID and 0.161 in. OD. The device's microchannel distribution makes delivery precise at low flow rates and accommodates various fluids. The regulator is compatible with EtO and gamma-irradiation sterilization methods.
Qosina Corp.
Edgewood, NY

Anesthesia-catheter connector

Offered by Raumedic AG, in collaboration B. Braun, the reconfigured Perifix catheter connector for regional anesthesia now includes an ergonomically designed safety closure that clicks acoustically as well as haptically to indicate a firm and reliable junction between the catheter and the connector. The latter company, a producer of polymeric tubing, precision moldings, and catheters, fashioned the bottom part of the catheter connector using the two-component injection molding method. The part combines a hard base with a soft component made from a high-performance thermoplastic elastomer especially developed for this application. The connector now consists of three components rather than five, as before. Its redesign facilitates its handling and use by physicians and patients.
Raumedic AG
Helmbrechts, Germany

Medical-grade polypropylene connectors

LinkTech Couplings' polypropylene couplings are now available in Legacy Almond and Modern Cool Grey colors. These color combinations allow customers to choose their preferred coupling color, improving their device aesthetics. Both color combinations are available in 20PP Series (1/8-in. flow size) and 40PP Series (¼-in. flow size), are produced from animal-free medical grade polypropylene, and can be Gamma sterilized. With more than 300 different styles and configurations, the company offers couplings that are well suited for use on durable and disposable medical equipment and analytical devices. Its couplings interconnect with other similar thumb-latch couplings and are available in more than 1000 styles and configurations.

LinkTech Couplings
Ventura, CA

How Materials Testing Can Assure Quality in Stent Manufacturing

Comprised of biocompatible metal or biodegradable polymers, stents bear a complex geometry, enabling them to act as effective scaffolds. As they must be able to push against the internal walls of the blood vessel or other conduit into which they are placed, their mechanical integrity is of the utmost importance. An insufficient level of flexibility can result in tissue damage while insufficient rigidity inhibits the device's capacity to support natural flow. 

Designed to address specific applications, stents are available in a wide range of sizes, diameters, mesh patterns, and strengths.An intraluminal coronary artery stent is a small, self-expanding, metal mesh tube placed inside a coronary artery following a balloon angioplasty procedure. This particular type of stent is designed to prevent the artery from re-closing. As it is placed within an artery, it is subjected to rather large forces that must be thoroughly characterized during the product development cycle and as part of quality management initiatives.

Zwick PrecisionLine Vario system
The Zwick PrecisionLine Vario system

Drug-eluting stents are among the most recent types of stents approved for use. Coated with time release pharmaceutical compounds, drug-eluting stents are also utilized in cardiovascular procedures to maintain blood flow. According to the New England Journal of Medicine, more than 500,000 patients in the United States are implanted with drug-eluting stents annually. A chief benefit is the reduced risk of repeat revascularization, a condition in which the patient requires additional cardiovascular procedures.  

Cook Medical has introduced a self-expanding stent designed to treat diseased veins near the hip and to correct vein stenosis in patients with obstructed vessels. Medtronic has introduced the Resolute Integrity drug-eluting stent produced from a single strand of wire that has been molded into a continuous sinusoidal pattern, increasing range of motion and thereby aiding deliverability.  

According to STI Laser Industries, Ltd., a leading supplier of machined stent assemblies, typical stent fabrication methods include: wire braiding or knitting, laser sheet cutting, and laser tube cutting. The Or Akiva, Israel-based manufacturer states that manufacturing begins with the selection of the optimal raw materials, then moves to high-precision laser cutting of complex geometries, and ultimately to final finishing procedures that include both surface and heat treatments. Surface treatments include polishing, honing, micro-blasting, pickling, electro polishing, passivation and ultrasonic cleaning. These steps result in a biocompatible product that bears a high degree of quality, a surface free of defects, and improved corrosion resistance.

While biocompatible metals have been the primary class of materials for stents, recent developments have seen the introduction of bioresorbable polymeric stents for a specific suite of applications. Metallic stents are typically comprised of the following biocompatible alloys:  Stainless Steel (316LVM), Nickel Titanium (Nitinol), Cobalt (L605), Cobalt Chromium (CoCr) or Nickel-Cobalt (MP35N). Some stents, such as those used for grafts, are made of fabric for use in larger arteries. Reliable characterization of these materials is necessary to meet surgical standards and to assure patient safety.

Balloon-expandable stents comprised of stainless steel and cobalt chrome alloys undergo an annealing process.  According to STI, annealing relieves internal stresses, softens the metal, improves the elongation rate, lowers the risk of strut breakage, and improves fatigue resistance. Self-expanding stents utilize the elastic properties of Nitinol and require a different process called shape setting to fix the final shape of the stent and the transition temperature.

Visual and dimensional inspections of the stents are undertaken throughout the manufacturing process utilizing high-resolution optical microscopes and video inspection systems. Such inspections are conducted to identify defects, to comply with customer specifications and to support adherence to ISO 13485:2003 and ISO 9001:2008 quality standards.

Advances in imaging technology and stent design have led to the manufacture of smaller delivery systems and thinner stent profiles. Fluoroscopic visibility of smaller stents decreases with their size and therefore requires the integration of radiopaque markers into the stent design. Markers are comprised of industrial-grade precious and semi-precious metals, including Gold, Tantalum and Platinum-Iridium.

Research and development engineers perform a range of tests on the materials used to manufacture stents, according to Erik Berndt, medical industry manager for Zwick/Roell, an Ulm, Germany-based manufacturer of material and component testing equipment.

"This is an extremely precise form of testing that calls for platforms capable of performing measurements with a high degree of accuracy," he said.

One of the primary challenges facing test engineers involves the gripping of test specimens that may be only a few millimeters in length and the measurement of elongations that are often in the range of just a few percentiles, Berndt said.

Sample preparation is key to accurate measurement. Because it is difficult to test a complete stent, small dog-bone shaped specimens comparable to stent parts are produced and tested. The stent sections are laser-milled to create the dog-bone shaped test coupons.

"Tests on new stent structures usually include analysis of radial compression force as well as standard tensile properties," Berndt said.

Radial compression tests are performed with machines such as the zwicki-Line system with a temperature chamber capable of elevating temperature up to 37 degrees C and specialized tooling.  While a test standard has not yet been finalized for radial compression tests, an ASTM task group is working to establish one and is engaged in the development of a draft.  While the standard undergoes development, ASTM F2081 and ISO 25539 are often employed as substitutes.  

"We offer an assortment of specialized tooling to measure radial compression in stent samples," Berndt said.

Tensile tests on stent samples are conducted with a Zwick PrecisionLine Vario system in combination with a temperature chamber, a laser extensometer and specialized fixtures that are designed to properly grip the samples.

"With this instrumentation we are able to grip specimens that are quite small, starting from 3mm length and width of only 0.2mm," Berndt said.

While gripping the test specimen presents one set of challenges, measuring strain presents a different set of issues.  Laser extensometers offer high precision, non-contact measurement of strain for delicate specimens undergoing extremely small changes in elongation. The latest in extensometer technology employs a non-contacting device that does not require measurement marks on the sample.

The laser extensometer utilizes the unique structure of a specimen's surface as a fingerprint to generate a virtual measurement mark.  A laser directed at these measurement positions is reflected in various directions corresponding to the surface structure and creates a specific pattern of speckles. Selected measurement points are tracked and converted to direct extension values. The change in the surface structure, which is the basis for the speckle pattern, is continuously evaluated during specimen deformation.

The laser interferometer-based method of non-contact extensometry allows test labs to characterize materials, components and subassemblies in quality control and research and development applications. Additionally, this approach to extensometry supports tests on micro-specimens with small gage lengths that require exceptional accuracy in strain measurement.

"Such tests would not be possible with traditional extensometry. Elevating throughput levels and delivering the utmost accuracy in strain measurement offers significant value for high volume test labs," Berndt said.

Management and control of the test process and equipment is achieved by dedicated software.  Zwick's laserXtens laser extensometer is directly integrated into the company's testXpert II measurement and control software.

Further streamlining of testflows may be realized by incorporating temperature as an external channel directly in testXpertII software. Making temperature available as a recorded channel places all test data within a single file structure, assisting manufacturers in recordkeeping procedures and supporting compliance with FDA 21 CFR Part 11.

Additional tests performed on stents include horizontal track equipment that can precisely measure the force required to guide a stent or catheter down a tortuous pathway simulating insertion in an artery or blood vessel. Zwick offers a horizontal test platform to conduct such simulations.                                   

Figure 1

Stents differ greatly in their design, dimensions and the optimal material for their fabrication, based on their intended application. The following table enumerates common stent applications and the range of possible dimensions:

Stent

Common materials

Diameter (mm)

Length (mm)

Thickness (mm)

Coronary

Stainless, CoCr

2.0-4.5

6-32

0.08-0.11

Neurovascular

Nitinol

2.0-5.0

6-50

0.10-0.15

Carotid

Nitinol

6.0-10.0

15-60

0.10-0.20

Peripheral

Stainless, Nitinol

9.0-14.0

20-80

0.15-0.20

Biliary

Nitinol

6.0-14.0

20-150

0.20-0.30

Erik Wittenzellner is a senior applications engineer for Zwick USA. Applying deep skills in the support of test system control electronics, Wittenzellner works in concert with customers to develop novel test procedures for a wide range of medical applications. He has been integral to concept development for fixtures that support complex testing requirements for medical device manufacturers.  Understanding the importance of applying built-in platform flexibilities, Wittenzellner frequently lends his expertise in test flow development to address the unique needs of individual customers.

FDA Guidance on Wireless Devices: What You Need To Know

FDA Guidance on Wireless Devices: What You Need To Know

Given the proliferation of medical devices using wireless technology—and the accompanying risks regarding security, performance, compatibility, and other challenges—FDA in August 2013 issued a guidance for radio frequency wireless technology in medical devices.

Learn more about incorporating wireless technology into your medical device designs by attending the Wireless and Mobile Technology in Medical Devices master class at the MD&M Minneapolis conference on October 29, 2013. 

Although the guidance states that it is only a recommendation and does not establish legally enforceable responsibilities, it is nonetheless useful for device makers. Guidances provide FDA’s interpretation of existing regulations and are frequently referenced by attorneys and courts in lawsuits seeking to establish that a manufacturer was negligent for failing to follow FDA statements in a guidance. Review of the wireless technology guidance, therefore, is critical for companies whose devices use such technology.

There are two parts to the guidance: One contains consideration for design, testing, and use of wireless technology and the other gives recommendations for premarket submissions for devices that incorporate radio frequency wireless technology.

The first part of the guidance sets forth recommendations and interpretations in connection with FDA regulations 21 CFR 820.30, which regulates the design of a medical device, and 21 CFR 820.100, which regulates procedures for corrective and preventive actions.

Per 21 CFR 820.30, manufacturers are required to establish and maintain procedures to ensure design requirements are met. These design procedures include addressing design reviews, conflicting design requirements, and procedures for design validation to confirm the devices conform to intended uses and needs.

As part of design validation, the guidance requires manufacturers to include risk analysis of wireless communications and control functions. Six factors should be addressed when dealing with design controls:

  • Selection and performance of wireless technology. Noting that many medical devices operate without a Federal Communications Commission license to incorporate interference protection, FDA recommends that manufacturers consider the allocation and availability of radio frequency bands to be used by the device, address how other existing users of selected radio frequency bands can impact a device’s operation, and describe methods of mitigating frequency band interference. To minimize electromagnetic interference with other devices, FDA recommends using the radio frequency that uses the lowest amount of power.
  • Wireless quality of service, or the quality of service for a device’s choice of wireless communication, whether by radio frequency, cellular telephone network, or other medium. The quality of connectivity and ability to ensure a connection should be considered.
  • Wireless coexistence. Manufacturers should address risks posed by interference from electromagnetic disturbances, such as voltage dips and electrostatic discharges, as well as interference from other technology using the same frequency. FDA recommends testing such devices in the presence of other devices using the same band, identifying the associated risks, and then justifying what is deemed to be an acceptable risk or demonstrating appropriate risk mitigation measures.
  • Security of wireless signals and data. FDA recommends vaguely that wireless medical devices use wireless security protection at a level appropriate for the risks presented and references its previously issued draft guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which recommends authentication (password log-in) and encryption.
  • Electromagnetic compatibility of the wireless technology. The guidance recommends that manufacturers address applicable standards and regulations, such as FCC requirements, regarding the potential for a wireless medical device to interfere with other equipment. But some voluntary standards recognized by FDA, such as IEC 60601-1-2, do not adequately address whether wireless communications will operate properly in the presence of electromagnetic disturbances, and FDA recommends that electromagnetic immunity testing be addressed in addition to meeting such standards. Users of wireless devices should be advised that the device conforms to IEC 60601-1-2 standards but that electromagnetic compatibility susceptibilities were discovered during testing.
  • Information for proper setup and operation. Appropriate information should be provided to users of wireless devices, including the specific type of wireless technology, FCC labeling, a warning that other equipment could interfere with the device, and advice that the user will need to recognize and address issues that might arise, such as the quality of service and management of wireless transmitters.

The guidance also recommends that manufacturers continue to manage wireless technology risks for the entire life cycle of the device. Procedures for implementing corrective and preventive action must include analyses for possible trends seen from complaints or reports of failures. If a failure or malfunction of a wireless function is identified, the cause must be investigated and action must be taken to correct the problem and prevent its recurrence. Measures include analyzing production and repair records and verifying any corrective and preventative action to ensure that such action is effective. This recommendation may be in reaction to well-publicized accounts of a hacker who was able to hack into his own wireless medical device and who was purportedly ignored by manufacturers.

The second part of the guidance recommends that manufacturers preparing premarket submissions for wireless medical devices include these four subjects:

  • A description of the wireless device’s technology and functions, how wireless-related risks are managed, and whether other devices are able to make a wireless connection to the device.
  • A risk-based approach to verification and validation, outlined by the concerns raised in the first part of the guidance regarding the design of wireless medical devices.
  • Summaries of test data, particularly electromagnetic compatibility tests.
  • A summary of the wireless medical device’s labeling that should include any precautions a user should take. FDA explicitly warns that label warning is not a substitute for risk mitigation measures.

The guidance provides not only insight into the FDA’s expectations with respect to premarket submissions and design protocols of wireless medical devices, but sets a standard for a manufacturer’s response to reports of complaints or problems with such products. Not only must the risks of wireless functions in new medical devices be foreseen and anticipated, but risks in existing wireless medical devices that may not have been present when the device was designed must also be investigated, and the process must be documented. This also has ramifications for potential liability exposure in future litigation, as manufacturers that fail to heed this guidance may be deemed to have not acted properly in either the design process or the postmarket surveillance process.


Michael D. Shalhoub is cochair of the life sciences and medical devices practice group at the law firm Goldberg Segalla. He has more than 30 years of experience defending manufacturers of health-related and personal care products. Reach him at mshalhoub@goldbergsegalla.com.

Soo-young Chang is an attorney in Goldberg Segalla’s cyber risk and social media practice group. He represents medical device manufacturers in product liability litigation and regulatory matters and has authored and presented on the subject of data security risk. E-mail him at schang@goldbergsegalla.com.

[image courtesy of David Castillo Dominici/FREEDIGITALPHOTOS.NET] 

How Innovations Using Sensors Can Disrupt Healthcare (infographic)

How Innovations Using Sensors Can Disrupt Healthcare (infographic)

A big factor powering the mhealth movement of course is the easily availability of wireless sensors. New entrants are also coming online. 

Here is a handy infographic made by Pathfinder, which focuses on healthcare software development, that shows the type of sensors already available and how they are poised to reshape the field of healthcare.

 

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
 

Report Predicts Top 10 Cardiology Device Firms in 2018

Market intelligence firm EvaluateMedTech predicts that Medtronic will be the top maker of cardiovascular devices in 2018. The firm, however, predicts that the business will grow rather slowly, at a rate of 2%. With worldwide sales of $8.7 billion in 2012, the business would be worth $9.9 billion in 2018.

Rounding out the top four cardiology device makers are St. Jude, Boston Scientific, and Abbott Laboratories. By 2018, EvaluateMedTech expects St. Jude to remain the second strongest cardiology device maker, while Boston Sci and Abbott will remain the third and fourth, respectively. With a CAGR of 7%, Edwards Lifesciences is poised to become the fifth biggest cardiology device maker five years from now. Propelling that growth is its projected growth in the transcatheter heart valve segment. At present, the company continues to have the only FDA-approved transcatheter heart valve on the market. The company recently received an IDE for its third-generation Sapien valve.

The report acknowledges that General Electric and Philips were not included in their rankings as they do not disclose their cardiology sales.

EvaluateMedtTech top cardio companies in 2018

The top five cardiology device makers would remain largely unchanged by 2018, if EvaluateMedTech's predictions hold true.

Rounding out the top ten cardiology device firms in 2018 are the following, all of which have a CAGR of 5% or higher:
  • J&J
  • Getinge
  • Terumo
  • Covidien
  • Asahi Kasei

Panasonic Healthcare Division Sells Majority Stake to KKR

KKR, a private equity giant, announced plans to purchase a majority stake in the healthcare arm of Panasonic for $1.67 billion. Following months of speculation and rumor, the Japanese manufacturer has finally found a potential buyer for its healthcare products division. Following the purchase, KKR will own four-fifths of Panasonic Healthcare. For now, Panasonic will retain ownership of one-fifth of the division. KKR will take majority ownership of the segment through one of its subsidiaries. According to Bloomberg, there were two bidding rounds for Panasonic's healthcare division before KKR emerged on top. Assuming that the purchase agreement is able to clear all closing and regulatory procedures, analysts predict that the sale will be finished by March of next year. With the sale, Panasonic will gain access to a significant amount of cash. The company's healthcare division manufactures a variety of healthcare product. This includes biomedical lab equipment, electronic health record systems, blood glucose monitoring systems and much. For Panasonic, this sale couldn't have come at a better time. Since the company's TV and semiconductor businesses have been experiencing losses, additional cash is welcome for Panasonic.

Top 10 Medtech Stories in September 2013

Much of the most popular content on Qmed for September related to the largest medical device companies. Johnson & Johnson was featured in three stories out of the top ten. Medtronic, Covidien, and Baxter also made appearances. While several of the stories had a negative slant, a number were substantially positive. A roundup of the top ten states for medical device manufacturing reflects the U.S. medtech industry's continued strength. Medtronic had a significant breakthrough in getting a novel diabetic device to pass regulatory muster at FDA, which could help pad the company's bottom line in late 2013.

  1. Three Medical Device Manufacturers with the Highest Profit Margins
  2. Covidien Plans Layoffs and Plant Closures
  3. J&J's Quality Control Questioned after Latest Recalls
  4. The Top 10 States for Medtech (Infographic)
  5. Layoff Race: Medtronic vs. Covidien
  6. Baxter Lays Off Nearly 100 after Regulatory Hiccup
  7. Obamacare: Lining the Pockets of Government Insiders?
  8. J&J's Blood Sugar Testing Patent Spat Turns Sour
  9. J&J's Ortho Unit May Change Ownership in Near Future
  10. Medtronic's Artificial Pancreas Wins FDA Approval

Watch This: A Mind-Controlled Robotic Leg

A new type of robotic leg uses rewired nerves for control. In the study, a 32-year-old an with an above-the-knee amputation received a specialized robotic limb that could be controlled by his mind. Results of the study were published in the New England Journal of Medicine.


According to researchers, the new system doesn't require the use of exaggerated muscle movements or a remote-control switch to go between different types of movement. On top of this, the robotic leg doesn't require manual repositioning with one's hands when sitting down.

"To our knowledge, this is the first time that neural signals have been used to control both a motorized knee and ankle prosthesis," note researchers.

Previously, researchers have successfully controlled robotic arms through the use of thought alone. With this latest project, muscle signals are used to amplify messages sent by a patient's brain.

To achieve this, researcher redirected a patient's nerves that previously controlled some lower leg muscles in the 32-year-old subject. This would cause muscles in the man's thigh to contract. This technique, dubbed targeted muscle reinnervation, can simplify the process of using an artificial limb.

Once this was done, researchers embedded sensors in the robotic leg. These sensors measured electrical pulses created by existing thigh muscles and reinnervated muscle contractions. When combined with data that came from additional embedded sensors, the robotic leg was able to accurately mimic the movement of a normal, healthy leg.