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Articles from 2013 In October

Polymer vs. Metal: The Battle of Bioresorbable Stents

Bioresorable (also known as bioabsorbable) stents are being held up as a promising alternative to standard drug eluting stents. But there's an internal battle (no pun intended) going on with bioresorable stents as well. Are polymer-based bioresorbable stents ideal for patients? Or should doctors opt for their metal counterparts?

Cases were made for both at the 25th annual TCT Conference in San Francisco, but researchers agree that polymer platforms have more data behind them. However, metal platforms should not be discounted as they may offer significant advantages over polymers.
The Case for Polymers
Right now polymer-based scaffolds (which are made of PLLA) have simply outpaced metallic bioresorbable stents when it comes to the quantity of data available. Dr. Syed Hossainy, director of the innovation incubator at Abbott Laboratories, a division of Abbott Vascular, said, “The reason I'm on the side of favoring polymer-based scaffolds is derived from significantly more clinical data that's available. Some of it is in comparison with the leading drug eluting stent [DES] and second generation DES designs. Lastly, there is a significantly more understanding of the mechanistic function for PLLA-based platform as opposed to a metallic absorbable scaffold.”
 The Absorb Cohort B demonstrated a favorable comparison between the Absorb and standard drug eluting stents. (image courtesy Syed Hossainy / TCT Conference) 
Indeed Abbott has collected nearly five years of clinical trial data between two different designs for its Absorb bioresorbable scaffold. The Absorb Cohort B study (conducted by Abbott), demonstrated that the Absorb scaffold has a comparable clinical performance to XIENCE, the current standard for non-absorbable drug eluting stents. 
Another study conducted to compare the Absorb to the Absorbable Metallic Stent (AMS) which made of magnesium and manufactured by Biotronik, found that the quick absorption of magnesium likely caused less structural integrity as compared to the Absorb, and that PLLA, unlike magnesium, does not immediately lose load bearing ability as it breaks down.
As the magnesium scaffold breaks down it was also found to leave chemical byproducts that could lead to potential complications such as ectopic calcification (calcium deposits in the soft tissue), whereas PLLA naturally breaks down into water and carbon dioxide, which are both naturally absorbed by the body.
Metals Answer Challenges
Dr. Ron Waksman, a professor of medicine at the Georgetown University MedStar Heart Institute in Washington D.C., Listed a number of issues with polymers:
  • Polymers are thick
  • They prone to inflammation
  • They are slow to expand during implantations
  • They are less deliverable
  • They are have a storage shelf-life
  • They depend on accurate imaging
  • They are prone to fractures
  • They are limited in calcified lesions
  • They are limited in bifurcation
  • They are not free from thrombosis (formation of blood clots)
There are also several other challenges that PLLA bioresorbables must overcome including temperature sensitivity, poor deliverability, and stent security retention. Waksman also outlined some perceptual challenges on the parts of doctors and patients. “They may think, 'This is a big device that delivers poorly,' the struts are very thick,' 'this plastic stent won't have enough strength.' ”
“When we're talking about metallic we're talking primarily about iron and magnesium,” Waksman said, outlining how bioabsorbable metallic scaffolds can overcome the challenges presented by polymers:
  • Iron and magnesium alloy has a similar radial force to stainless steel and cobalt chromium stents.
  • The profile of metallic scaffolds is superior to PLLA and they are more deliverable.
  • Metallic bioresorbable scaffolds feel like metallic stents and bioabsorb within 6-12 months for magnesium and 12-36 months for iron.
A key point Waksman made was on the issue of scaffold malapposition – when a stent's struts separate from the vessel wall. He cited a cohort study, presented in 2011 at the American College of Cardiology of the Absorb that showed an 81.1% rate of malapposition. “In contrast in the magnesium the OCT demonstrated a very minimal malapposition post procedure at 6 months and 12 months...respectively the metal is performing better,” Waksman said, citing a year-long study of the Biosolve magnesium scaffold (also known as DREAMS) by Biotronik, which showed 97.3% of the stents still apposed after 12 months.
A 12-month study of Biosolve showed very little malapposition among implants. (image courtesy Ron Waksman / TCT Conference)
What about Patient Outcomes?
Differences in structure or perception aside, what doctors really want to know is what are the patient outcomes when it comes to polymer versus metal.
BIOMEDevice San Jose will be hosting seminars on "Advanced Materials and Device Technology" on Dec. 5, 2013
A Biotronik-funded study on the Biosolve-I showed no instances of cardiac death or scaffold thrombosis, and low instances of target lesion failure, myocardial infarction, and target lesion revascularization up to 12 months for the Biosolve. Waksman also talked of the next generation Biosolve (the Biosolve-II) which will be more flexible and feature slower dismantling and absorption rates (magnesium currently absorbs faster than PLLA), and increased deployment diameter, and higher acute radial force among other features.
Polymer advocates may wish to note that the Biosolve-II will employ a PLLA coating for drug delivery - fueling speculation that a combination product may be the ideal solution.
The interventional cardiologist are used to metallic stents and prefer to use them,” Waksman said, noting that studies for the Biosolve-II are currently gearing up. “Plastic is not metal it is thick, hard to expand, and tends to break.” Waksman believes that if studies show metallic ioresorbable stents to have comparable efficacy to standard metallic stents then devices like Biosolve will win the day.
While both sides are showing some pros and cons - and clinicians have said they like both options - the ultimate question on clinicians' minds is whether PLLA can ever physically match the properties of metal and whether metal can overcome some of its other challenges to match the safety of PLLA. Only time, and more clinical data, will tell.  
-Chris Wiltz, Associate Editor, MD+DI

Investors Open Wallets for Svelte Stent System

New Providence, NJ-based Svelte Medical Systems appears to have hit on some improvements to drug-eluting coronary stent platforms, and the company is attracting the attention of investors. Svelte's $22 million money-raise, announced Thursday, suggests stents still have some sexiness -- even as questions are raised about their possible overuse. Some physicians have voiced concern that stents are being over-used to treat cardiovascular disease. Supporting that argument is a recent study published in The Lancet, which reports that diabetic patients who receive coronary bypass surgery have better outcomes compared to those treated with stents. Svelte, though, has managed to raise a total $65 million since it started in 2007, with the latest fundraising round led by CNF Investments and New Science Ventures on top of previous investors. The new infusion of cash will fund research, an expansion of Svelte operations and preparations for a planned 2015 European commercial launch of the company's drug-eluting coronary stent Integrated Delivery System (IDS) and Rapid-Exchange (RX) platforms. So what makes Svelte so special? The answer appears to be incremental, but nevertheless attractive, improvements. For example, Svelte's balloons use proprietary Balloon Control Bands which envelop the balloon shoulders to provide a smooth leading edge during delivery and uniform, controlled balloon growth during stent expansion. Designed to facilitate direct stenting, the high-pressure balloon can also be used for multiple post-dilatations, further minimizing procedure time and cost. The drug-coating technology utilizes naturally-occurring amino acids that can be absorbed over about nine months through enzymatic digestion, rather than water-based digestion, avoiding bulk degradation and acidity change, two common causes of inflammation around stents.

A Hipper Knee Implant Helps Boost Smith & Nephew Earnings

Growing U.S. sales of Smith & Nephew's Journey II BCS Knee helped the British medical device company score strong third quarter earnings. The knee implant appears to address the needs of aging baby boomers seeking knee plants at ever younger ages. The key appears to be the company's Verilast technology, which uses a patented oxinium (oxidized zirconium) alloy in which the surface is transformed to ceramic to reduce friction. Smith & Nephew explains on its Journey II website: "With the patient population shifting not only to more activity, but also opting for intervention at an earlier age, the implants' durability in regards to wear (long-term performance) and managing complications are more important than ever." Add in sales growth in emerging markets and a booming wound-care business, and London-based Smith & Nephew had good third-quarter news: sales up 5% year-over-year to $1.027 billion and profits up 10% year-over-year to $222 million.

Why Tiny Electronics Are Having a Huge Impact on Medical Technology

Microelectromechanical systems (MEMS) are already used for an array of applications in medical devices, many of them related to sensing, diagnostics, micro-fluidics and drug delivery. This is just scratching the surface of what is possible. Potential breakthroughs on the horizon include the use of silicon microneedles, which could be used to treat diabetes and implantable MEMS sensors that could track everything from cardiac function to cranial pressure.

Chris Folk
Chris Folk will be speaking on MEMS and NEMS breakthroughs at  BIOMEDevice San Jose.

Further down the road, the applications of the technology in medicine is poised to expand further as the size of systems shrinks to the nanorealm. Nanosized devices could mimic natural biological processes and specifically target, say, cancer cells. Nanotech based systems could be used to predict a heart attack before it happens or detect the earliest stages of cancer. Last year, an article on the former idea was published in Science Translational Medicine.

To learn more about this subject, MPMN reached out to Chris Folk, who is principal engineer, device strategy at Amgen. Folk will be speaking on the subject in the BIOMEDevice San Jose conference, which is scheduled for December 5.

MPMN: Over the years, I've seen several announcements from universities on MEMS and NEMS breakthroughs that could assist in the development of new diagnostic devices and implantable microdevices. Which MEMS and NEMS technologies with potential medical applications are you the most excited about and why?

Folk: For implantable technologies, Second Sight, Replenish, MicroCHIPS, and CardioMEMS are leading candidates for trailblazers, with very different therapeutic areas. Second Sight is restoring vision to the blind due to retinitis pigmentosa. Replenish has an implantable drug-delivery technology to directly target therapeutics to the eye. MicroCHIPS has biosensor, wireless, and drug-delivery technologies. CardioMEMS is struggling with the Champion trial, but the safety of the technology has been supported by the FDA.

More broadly, the marriage of MEMS/NEMS and cell phones is causing an explosion of mobile-health and digital-self technologies. Curative technologies like the four I've cited tend to have the biggest "wow factor," but the predictive/preventative solutions developed in mobile health may lead to the greatest savings in healthcare and improvement of quality of life.

CardioMEMS is among the trailblazers in the field of using MEMS technology to integrate devices and health IT. They were a 2012 Intel Innovation Award Finalist.

MPMN: I've heard about nanotechnology research that could one day predict heart attacks before they occur or predict the earliest stages of cancer. Are you familiar with such predictions?

Folk: Yes, these refer to nanotech applied to microRNA profiling, On the MEMS side, lab-on-a chip technologies are intended for real time assaying. We'll look at these technologies in my talk.

MPMN: Could you provide some examples of promising cutting-edge nanotechnology-related applications that are more therapeutic (perhaps related to drug delivery) than diagnostic?

Folk: Drug companies are actively investigating nanotech therapies, including polymer micelles or dendritic technology for drug delivery, or gold nanoparticles to heat and destroy tumors.

MPMN: There has been a lot of excitement surrounding the field of nanotechnology but some fears about it as well. What kind of regulatory challenges do you envision nanotech-enabled devices encountering and what advice would you give on how to minimize potential safety problems when working with groundbreaking nanotechnology in medicine?

Folk: This is a big question! In general, the problem with small particles is knowing where they go, understanding their impact to the various organs they come in contact with, and learning if/how to track them in clinical trials. Cytotoxicity, renal clearance, enhanced permeability and retention (EPR) effect, and reticuloendothelial system (RES) recognition must all be understood.

MPMN: According to the outline of your talk, you will touch on the challenges of integrating MEMSs and NEMs into medical devices. Could you summarize some of those challenges and your advice for how to overcome them?

Folk: There are several topics to cover here. In my opinion, many MEMS and NEMS researchers have little experience in traditional medical device development. Thus, they try to apply the nano/MEMS "hammer" to every product requirement "nail." A large opportunity is to focus the technology on one critical task.

Packaging challenges are pervasive in the field. We can expand on this area as well.

MPMN: Do you have any advice for engineers with medical device experience who are looking to land jobs at pharmaceutical companies to help with their drug-delivery technology? I've heard this is something of a trend and was curious to hear your thoughts on it.

Folk: First, be good at what you do. If you're a ME, be grounded in core principles. Understand fluidics, pumps, valves, motors, actuators, and the physics of each. If you're an EE, understand systems, sensors, power, and microcontrollers. There's a shortage of great engineers, and it's never been a better time to self-educate via MOOCs and the like, so go for it! Here's a good test: find a top-notch colleague, and have them grill you on your work for 30 minutes. You'll soon discover your strengths and weaknesses.

Second, bring something unique to the table. Perhaps you've worked on a fluidic system before. Perhaps you have a particular relevant technology strength. Highlight and demonstrate it on your resume and in interviews.

Third, have demonstrable proof of your creative potential. The drug-delivery space is evolving very rapidly, and companies are looking for engineers who will be leading development platforms far beyond today's purview. If you are stuck in line-extension or remediation land, create opportunities to flex your creative capacities.

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

Thoratec Sees Strength In HeartMate Product Line

Thoratec (Pleasanton, CA) released positive Q3 results. In part, results were boosted by the company's HeartMate pump product line. For the quarter, Thoratec landed revenues of $126.4 million. This represents a year-over-year increase of 7%. In total, $112.8 million of Q3 2013 revenue came from sales of the company's HeartMate left ventricular assist devices (LVADs). During Q2 2013, Thoratec pulled in revenues of $130.5 million, a year-over-year increase of 10%. For Q2 2013, $115.7 million came from HeartMate sales. That said, net income for the company was $18.9 million in Q3, representing a slight decrease from $24.3 million during the same time last year. In part, the company noted that this decrease was due to the purchase of Terumo's DuraHeart II for a maximum price of $56.5 million. In that deal, Thoratec agreed to pay $13 million upfront for the device and an additional $43.5 million based on the successful attainment of sales and regulatory milestones. "Thoratec generated strong results during the third quarter, highlighted by continued growth in our HeartMate II and CentriMag product lines," noted Gary F. Burbach, president and CEO of Thoratec. "We continue to drive expansion of the worldwide market for MCS therapy and delivered international revenue growth of 32% during the quarter."

Elixir Medical Releases Positive 12-Month Results for DESolve

Elixir Medical Corp. (Sunnyvale, CA) released positive one-year clinical results for its DESolve Novolimus eluting coronary scaffold system. Results were presented at the Transcatheter Cardiovascular Therapies Conference in San Francisco, CA. "The 12-month results of the DESolve scaffold demonstrated sustained clinical outcomes at one year, further validating the scaffold as an excellent treatment option for coronary artery disease," noted one researcher. In total, the DESolve clinical trial comprises 126 patients at 13 separate centers in New Zealand, Brazil, and Europe. While all patients underwent a quantitative coronary angiography, a subset of 46 patients also underwent optical coherence tomography and intravascular ultrasound imaging at baseline of the study and at the half-year mark. Results show that the rate of major adverse cardiac events in trial patients was 5.69%. As of now, bioresorbable scaffolds have been a challenge for the medical device industry. In part, these devices require a level of structural strength that has only been found in metallic stents. However, the DESolve device is able to overcome this issue and is able to achieve patient vascular restoration within half a year. The scaffold is developed from a specialized poly-L Lactide polymer, providing durability and strength. In addition, this polymer is designed to elute Novolimus, an antiproliferative drug. The main benefits of the scaffold include its ability to have a wide expansion margin, its ability to maintain radial strength, its ability to self-appose up to a patient's nominal vessel diameter and its ability to show lumen area increase at the six-month post-vascularization mark.

Top Products and Services of 2013

MPMN continues the tradition of honoring the top products and services of the year, which were chosen using a survey sent out to our readers. For each of the categories below, the two most popular products were included. In the case of a tie for first or second place, three products were included. 

Pumps and Valves

Microfluidic valves 
Microfluidic valves from BurkertCombining the proven rocker principle with an innovative actuator enables Twin Power microfluidic valves from Burkert Fluid Control Systems to maintain given levels of performance and reliability in a smaller valve design with lower power consumption. The dual-solenoid valves are available in 10-, 16-, and 22-mm sizes. They also exhibit the flow and pressure resistance typically found in larger valves, making them suitable for applications in which space is critical or strong performance is needed. The 10-mm valve comes with orifices sized up to 1.6 mm and with pressure resistance as high as 73 psi; the 16- and 22-mm models are available with a 3.0-mm orifice. Maximum pressure resistance is 29 psi for the 16-mm valve and 73 psi for the 22-mm valve.
Burkert Fluid Control Systems

Piezoelectric diaphragm micropumps
Piezoelectric diaphragm micropumps from ServofloBased on piezoelectric diaphragm pump technology, the self-priming micropumps in the MP-6 series from Servoflo Corp. deliver air, gases, or liquids in low-flow portable medical equipment applications, such as drug-delivery devices, infusion pumps, nebulizers, respiratory equipment, and point-of-care platforms. These stock pumps measure 30 × 15 × 3.8 mm, consume less than 200 mW of power, and are capable of cycling several-hundred times per second. Typical flow values are 18 ml/min maximum with 100-mbar backpressure for gas and 7 ml/min with 600-mbar backpressure for water. Custom pump modifications can be made to meet customer requirements. A polypropylene version is available for handling corrosive media. Evaluation kits are available.
Servoflo Corp.

Cleanroom Manufacturing and Assembly

Production, assembly, and testing services 
MedPlastOutsourcing partner MedPlast is a full-service custom medical device manufacturer equipped with Class 100,000 cleanrooms for molding and assembly. It also offers extensive product testing capabilities. Its in-house laboratory services include monitoring of the production environment for microbial contaminants that could compromise the final sterilized product. The company also performs bioburden and Limulus amebocyte lysate testing. In addition to lab tests, it conducts a variety of in-process and final testing during the manufacturing process, including customized pull testing, drop testing, leakage testing, flow testing, and electrical testing. The ISO 13485- and ISO 9002-certified and FDA-registered contract manufacturer offers capabilities in injection molding, blow molding, silicone materials, and silicone processing.

Cleanroom leasing 
A full-service medical device contract manufacturer registered with FDA and operating a facility certified to ISO 13485:2003 standards, Life Science Outsourcing Inc. has 10,000 sq ft of Class 10,000 cleanroom space used primarily for the manufacture of Class II and Class III devices. The company can lease cleanroom space to OEMs on a daily, weekly, or monthly basis, providing allocated spaces for confidential or special projects. The cleanroom houses equipment, tooling, and assembly fixtures for ultrasonic component cleaning, ultrasonic welding, tray sealing, and such microprocesses as soldering. Providing a turnkey outsourcing solution for both startups and large medical device companies, the company offers sterilization, packaging validation, and warehousing services as well.
Life Science Outsourcing Inc.

Assembly Equipment

Ultraclean assembly robots
DensoCompact VS-series six-axis robots from Denso Robotics are available in ISO Class 5 and ISO Class 3 cleanroom versions for use in medical device assembly applications requiring very high levels of contamination control. The high degree of flexibility inherent in the robots' articulated design and choice of end effectors, according to the manufacturer, makes them suitable for performing a variety of high-speed, high-precision assembly tasks and for carrying out such secondary operations as packaging, testing, and inspection. Assembly cycle times range between 0.37 and 0.33 seconds and repeatability between ±0.03 and ±0.02 mm. Offering reaches of 500 to 900 mm and payload capacities of 4 to 7 kg, the robots can be mounted on the floor, ceiling, or wall. They have ultraslim arms that facilitate production-line integration, and an optional bottom-side cable connection saves floor space.
Denso Robotics

Assembly fluid dispensers
NordsonAvailable from Nordson EFD, the high-precision Ultimus V and Optimeter dispensing systems for adhesives and other fluids used in critical medical device assembly processes have been designed to keep fluid quantities consistent as viscosity changes or the volume of fluid in the syringe decreases. The former dispenser models can store and then automatically adjust dispense settings to keep the volume of applied fluid constant in the case of fluids that undergo viscosity changes. To compensate for changing fluid levels when thinner fluids are used, the latter model automatically adjusts airflow to maintain uniform deposit size. The dispensers enable users to set dispense parameters in standard, metric, or SI units and to select among English, Chinese, French, German, Italian, Japanese, Korean, and Spanish as the language for menu displays and prompts.
Nordson EFD

Cables and Connectors

Medical cable assembly services
Lemo medical cable assembliesA supplier of custom medical connection systems offers the value-added service of providing custom cable assemblies to fulfill medical device design requirements for complex diagnostic and therapeutic applications. Lemo USA Inc. can supply 100% tested and RoHS-compliant medical wiring and cable assemblies for such critical products as imaging equipment, surgical and other medical instrumentation, and orthopedic and prosthetic supplies and apparatuses. Not only does the company design systems to meet UL/IEC 60601-1 patient safety standards, but it also works in collaboration with the client during product development to ensure that these standards are met. The service provider employs sealed connectors for wet applications, stainless steel for longevity and hot sterilization, mixed configurations (fluidic and pneumatic subsystems in one connector), plastic materials familiar to the medical industry, and soaker caps for chemical sterilization.
Lemo USA Inc.

Push-pull interconnect
FischerThe ultra-high-density MiniMax push-pull interconnect system from Fischer Connectors USA is a rugged miniaturized connector designed for smaller devices. An all-in-one 20-signal (0.5-A per signal) and 4-power (5-A) connector with 24 mixed contacts, the interconnect offers durability of better than 500 mating cycles. It has passed tests to establish suitability for use in harsh environments. The connector has a profile of less than 7 mm inside the box, a design that prevents power and signal from interfering with each other, and an unbreakable keying system that withstands more than 4 Nm of torque. It is delivered precabled.
Fischer Connectors USA

Extrusion Services

Custom extrusions
Teleflex Medical OEM offers services involving the extrusion of PTFE, FEP, EFEP, and other high-performance thermoplastics in dimensions ranging from microminiature through 35F. Equipped to handle challenging applications, the company produces heat-shrink and spiral heat-shrink tubing, multilumen tubing, coextrusions, and profiles, among other extruded items. Its capabilities additionally comprise standard and embedded marker bands, radiopaque fillers, and braid and coil reinforcement, including variable-pitch, continuously coiled shafts. The integrated, full-service contract manufacturer serves as a single-source provider of diagnostic and interventional catheters and sheath-dilator sets and kits.
Teleflex Medical OEM

Variable-flexibility extrusion technology
A provider of advanced extrusion services uses proprietary Taper-Tie continuous-extrusion technology to make variable-flexibility tubing for catheter shafts requiring high flexibility at one end for forward navigation and rigidity at the other to facilitate directional control by physicians. Specializing in the production of minimally invasive medical devices, Putnam Plastics Corp. designed the technology to replace traditional manual assembly of catheters with segmented shafts and eliminate associated labor costs. The continuous manufacturing method produces a catheter shaft that has variable properties along its length from the moment it is extruded. The process allows for quickly changing from rigid to soft grades of a designated polymer along the shaft while simultaneously reducing wall thickness during the extrusion.
Putnam Plastics Corp.

Adhesive Dispensing and Curing Equipment

Dispensing pump

The fully programmable VMP electronic variable-displacement metering pump accurately dispenses ultraviolet (UV) radiation-sensitive fluids, including UV-curable assembly adhesives. Available from Fluid Metering Inc., the dispenser features a precision stepper motor that controls the pump speed and employs the manufacturer's patented CeramPump valveless piston pump design. Made of Type 316 stainless steel or opaque PVDF, its pump head keeps UV light from affecting process fluids in transit. A second stepper motor electronically adjusts the piston displacement; by varying the length of the piston stroke, dispense quantities can be finely tuned. This dispenser can be programmed for a variety of functions via a user-friendly touch screen interface that can control up to 16 pumps on a single bus; up to 128 metering devices can be controlled using a PLC or computer.
Fluid Metering Inc.

Valve dispensing systems
Utilizing a pneumatic, normally closed diaphragm valve, Dymax Corp.'s Model 475 valve dispensing systems accurately dispense low- to high-viscosity fluids. The design of the internal diaphragm and adjacent parts prevents migration of fluid into the actuating section within the valve. The toughness of the diaphragm, along with the selection of appropriate materials for component construction, ensures long diaphragm and valve life between maintenance schedules. These features make these valve systems suitable for dispensing light-curable materials and such reactive materials as cyanoacrylates, anaerobics, and solvent-based products. Accurate, repeatable performance is achieved by using the valve's stroke adjustment knob to dial in a desired shot volume. And a 25-µm air filter regulator permits only clean, dry, particulate-free air to pass, ensuring the system's long and continuous life. The regulator includes an integrated shutoff valve and pressure exhaust to quickly and safely depressurize the system, eliminating the need for the operator to open and close the regulator.
Dymax Corp.

Wound Care Technologies

Breathable polyurethane film
MylanMedifilm 426, a breathable polyurethane film on a removable carrier, is available for use in skin-contacting applications such as IV-site dressings, wound-care dressings, and incise drapes. Manufactured by Mylan Technologies, the product can be supplied with hypoallergenic pressuresensitive adhesives. It consists of the extruded polyurethane film on a paper/polypropylene liner and has a thickness between 0.5 and 10 mil, a thickness range that is standard with all the films in this line of wound-care and ostomy devices. The film has a medium-level coefficient of friction and moisture vapor transmission rate. It can also be customized by the inclusion of pigments such as flesh tones, embossed matte or gloss finishes, antistatic agents, and other options.
Mylan Technologies

Custom adhesives
A manufacturer of pressure-sensitive adhesive (PSA) tapes provides custom adhesive technologies for wound-care products and other skin-contacting medical devices. For long-term-wear applications requiring an aggressive adhesive, Adhesives Research Inc. supplies a medical-grade acrylic adhesive technology that offers high moisture-vapor transmission rates (MVTR) for breathability, good wear properties, minimal edge lift, and tolerable removal with no adhesive residue left on the skin. This adhesive supports dressings intended for wound sites posing potential adhesion difficulties and can be tailored to bear the weight of skin-attached medical devices and pump patches. Also available is a low-trauma-adhesive (LTA) platform for gentle skin removal. This customizable, high-MVTR PSA technology maintains reliable skin contact for up to three days and allows removal and reapplication without the adhesive bonding to itself. The gamma-sterilization-compatible LTA formulation leaves no residue and is biocompatible, noncytotoxic, and nonirritating or sensitizing to the skin.
Adhesives Research Inc.

Packaging services:

Custom packaging
Offering full-range medical device packaging services, CleanCut Technologies specializes in manufacturing compliant device packaging systems in a controlled environment. The company operates ISO Class 7 and Class 8 cleanrooms in its ISO 13485-certified facility and offers full traceability of the raw materials it uses. In order to ensure full performance effectiveness, the service provider develops and designs packaging in consultation with customers. For example, it offers a patented clipless dispenser that protects guidewires and catheters while minimizing the environmental impact of packaging materials.
CleanCut Technologies

Cleanroom packaging, pouch sealing
Plastics OneAlready equipped with several ISO Class 8 and ISO Class 7 cleanrooms for molding, assembling, and packaging plastic components, Plastics One Inc. has added independent cleanrooms for medical device packaging and medical pouch sealing. These cleanrooms are certified to ISO Class 7 standards for sterile barrier packaging and molding. The service provider works directly with customers worldwide to create advanced package designs. Its ISO 13485-and ISO 9001-certified facility includes an in-house design department using 3-D software, a fully equipped mold-making shop, and current injection molding technology. The company additionally offers a dedicated R&D team, enabling it to provide contract packaging services extending from product concept to creation.
Plastics One Inc.

Testing, measurement, and inspection equipment

High-definition camera

The IK-HR2D high-definition camera from Toshiba Imaging Systems Div. can be used to add full-motion, live video output to microscopes employed for inspecting circuit boards, assembling devices, and performing other inspection, testing, and measurement tasks in which real-time, high-resolution, high-quality color imaging is critical. Besides being in high resolution, the images captured exhibit good contrast and clarity. Supporting ergonomic and efficiency objectives, the one-piece, compact CMOS high-definition camera measuring 1.73 × 1.73 × 3.17 in. offers live-image data capture at speeds up to 60 frames per second and includes both DVI-D and USB outputs. User-selectable video output formats include 1080p/720p at 60 fps and 1080i at 30 fps. Video frames can be output at up to 10 fps via the built-in USB port for convenient transfer of live images to a computer without the use of a frame grabber.
Toshiba Imaging Systems Div.

Tabletop universal testers

ShimadzuThe EZ Test EZ-X series of compact tabletop test systems has been designed by Shimadzu Scientific Instruments to provide high levels of test force measurement precision, control precision, and test speed. The universal testers can be configured into 29 models that are designed to meet small-capacity testing requirements for the medical device industry. They offer ±0.5% accuracy over a range of 1/500 of load capacity to full capacity and allow data sampling at speeds up to 1000 measurements per second. A high-speed, long-stroke model features a 3000- mm/min return speed that minimizes the wait between tests. To extend the range of possible test applications, the manufacturer offers a selection of specialized jigs for sample preparation and evaluation of device properties. This series of test units can inspect such items as syringes, adhesive bandages, and packages for physical characteristics and other performance criteria.
Shimadzu Scientific Instruments

Leak/flow-testing instruments

InterTechLeak-testing flexibility is built into the Med75 Combo instruments for medical device leak and flow testing from InterTech Development Co. These leak testers perform a range of functions: leak and flow testing for medical products, pressure-decay and mass-flow leak detection in combination, and leak and flow testing for catheters. Several options, including as many as four independent channels, allow users to conduct the tests that best suit the application. The several test circuits operate independently, with individual pressure regulators, valves, and calibration ports. A touch screen control panel, dual USB ports, Ethernet connectivity, and embedded Web pages all facilitate data management. The leak detectors can be employed as stand-alone instruments, or they can be interfaced with a PC or an external programmable logic controller, through which setup is automatic.
InterTech Development Co.

IV components, tubing connectors, and couplings

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

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.

Molding services

Custom miniaturized components

An ISO 13485:2003-certified supplier of high-volume molded medical  device parts can provide custom miniaturized components in a range of   advanced iso 10993- and usP class Vi-compliant polymeric materials.   Minnesota rubber and Plastics molds miniature components for such devices as fluid-delivery systems, along with numerous other static and   dynamic applications, using custom blends of Peek, polycarbonate, polysulfone, nylon, polyethylene, and polypropylene. components   characterized by sterilizability, chemical compatibility, biocompatibility,  toughness, durability, and hydrolytic stability at elevated temperatures  can be as small as 1 mm in diameter and weigh under 1 g.
Minnesota Rubber and Plastics

Contract molding and assembly

MedbioMedbio, a contract manufacturer specializing in injection-molding components and assembling medical and biotechnology devices, is  equipped with four modular Arburg swivel-clamp molding machines that enhance the contractor's flexibility. the latest purchase is a 28-tn hydraulic molding machine that offers a range of working positions. using the machines, the molder can run a variety of precision molded parts, performing overmolding and insert molding using a vertical clamp position or automatic molding with a horizontal clamp position.
Medbio Inc.

Accelerated tooling service

The full-service medical device contract manufacturer Sil-Pro offers Jet tooling, a service designed to produce mold and extrusion tooling and functional prototype parts from silicone or thermoplastic material in a few days. the ISO 9001:2008- and ISO 13485:2003-certified specialist has a dedicated tool shop, and a five-axis machining cell with robotic support for around the-clock production gives it high-speed capabilities. a fast tooling service features an in-house inventory of originally hard and hardened stainless-steel inserts, offers an extensive material selection, can supply bridge tooling to preproduction and small production runs, and enhances design for manufacturability.

Catheter and stent manufacturing equipment

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.

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.

The Evolving IVD Reimbursement Landscape in 2013

Despite unprecedented advances in laboratory medicine, the Medicare agency is dealing with the in vitro diagnostics boom with an unprecedented series of roadblocks, odd rules, and price cuts.

By Bruce Quinn, Foley Hoag LLP

Bruce QuinnWe are living through a period of unprecedented advances in laboratory medicine, as evidenced by a just-released FDA report, “Paving the Way for Personalized Medicine.” In this report, FDA describes how it is generating informative new guidance documents, improving the internal collaboration between drug and in vitro device departments, and speeding targeted medicines to the clinic. The agency is also pushing forward initiatives to bring true genomic medicine to the clinic, such as high-resolution genomic HLA and blood group testing, which can now assess dozens of genes in efficient and rapid panel tests.

Unfortunately, in the world of reimbursement, there is no similar cross-agency report of goodwill and achievement. Instead, the Medicare agency is dealing with the boom in diagnostic medicine with an unprecedented series of roadblocks, odd rules, and price cuts. While the lab industry has experienced a lurching pattern of genetic test nonpayments and price cuts this year, this nonsense can be traced back to 2006, when Medicare promulgated its “14-day rule” for the date of service of laboratory tests. 

Under this short yet almost unreadable rule, a test performed as late as several weeks after an inpatient stay is “bundled” to the original hospital payment for that patient. That means no new payment. Of note: There is no corresponding rule that retroactively bundles CT or MRI tests to a prior hospital visit; this rule is unique to clinical laboratory tests. This rule is also extremely difficult to comply with. It actually assigns one of three different dates as a lab test’s date of service based on analysis of five other dates—the date of surgery, the date of discharge, the date the test is ordered, the date a specimen is pulled from an archive, and the date the test is performed! While originally intended to impact inpatient surgical specimens, the rule now applies equally to simple blood samples taken during an outpatient visit if the outpatient clinic has a hospital affiliation. 

In addition to the ongoing struggles with the 14-day rule, five entirely new challenges have emerged this year. First, Medicare was a year late in using the new genetic test codes, created in 2011, and priced them erratically, which, in turn, elicited much protest from the industry. This was called administrative price setting by the “gapfill” method. 

Then, in the summer of 2013, three more challenges arose. The agency announced it would attempt to reprice all clinical lab tests based on its estimation of technical costs; bundle all hospital outpatient lab tests to that day’s “service,” such as an office visit; and cap the price of some physician pathology tests at 50% or less of prior levels. The fifth and final challenge was the agency’s refusal, so far, to acknowledge that some modern lab tests are multi-analyte assays, such as the Genomic Health Oncotype DX test and the Vermillion Ova-1 test, of a type which result in a single report rather than a list of analyte measurements. 

All of these proposals triggered both written and in-person responses from the lab industry and those who understand its value. Many stakeholders from companies and associations alike also met with their congressional representatives, who, in turn, generated letters from Capitol Hill to the agency. 

The results of the current-year policy proposals would normally be released around November 1, but will be delayed a few weeks by the recent government shutdown. What is already clear, however, is that the agency probably cannot be trusted to do the right thing, or even the sensible thing, when faced with rapid change. The IVD industry needs to be active, insightful, and reasonable in educating the public, the Hill, and federal agencies such as Medicare about the value and enormous impact of IVD tests on modern healthcare. Too much bureaucracy and equivocal policy signals scare off much-needed investment and continued innovation when they’re needed.

Bruce Quinn will present on "The Evolving IVD Reimbursement Landscape: Healthcare Reform and Understanding Obstacles to FInancial Success" at the IVD Business Strategy Conference in San Diego November 6-8.

Bruce Quinn, MD, PhD, is senior healthcare policy specialist at Foley Hoag LLP and national expert on Medicare policy, the impact of health reform on innovation, and the crafting of successful business strategies within the U.S. healthcare reimbursement system. Since 2008, Dr. Quinn has been a full-time business strategist working with attorney and policy teams for healthcare and life sciences clients in the firm’s Government Strategies practice. Before joining Foley Hoag LLP, he was the regional Medicare medical director for the California Part B program. Earlier in his career, Dr. Quinn was a physician executive in the Health & Life Sciences division of Accenture, working with the pharma, biotech, and genomics industries.

Teleflex to Acquire Vidacare for $262.5 Million

Teleflex announced plans to acquire Vidacare, a Texas-based cardiovascular device manufacturer, for $262.5 million. Teleflex plans to use its latest acquisition's vascular / bone access devices to boost its own product line. According to information from Teleflex, the deal is slated to close in the fourth quarter of this year. Vidacare manufactures vascular access devices that can help physicians access the interior of a patient's bones. Potential applications include diagnoses, therapies and medical interventions. Fields of medicine that use inside-the-bone / vascular access devices include spinal surgery, oncology and emergency medicine. The company's flagship products include the OnControl Bone Marrow System and the EZ-IO Intraosseous Vascular Access System. "The acquisition of Vidacare, an industry leader with a high gross margin profile, will expand our comprehensive vascular access product portfolio with a defining technology," stated Benson Smith, president and CEO of Teleflex. For Teleflex, Vidacare is the largest acquisition in recent memory. However, there have been several small acquisitions over the past few years. In June, Teleflex purchased Israeli startup Eon Surgical, a small manufacturer of minimally invasive microlaparoscopy technologies. Last year, the company made a significant number of purchases too. Teleflex's 2012 acquisitions include Hotspur (a manufacturer of a two-in-one balloon dilation catheter that works with the company's Vision Valve injection system) for $15 million. Teleflex also acquired Semprus Biosciences, a vascular access technology manufacturer, for $30 million. In addition, the company acquired LMA International for a price tag of $276 million, giving the company access to several laryngeal masks for use during emergency care and anesthesia.

Stenting Language Gets a Makeover by American College of Cardiology

Following concerns of stent overuse, the American College of Cardiology revised the language used for stent treatment guidelines. Starting next year, the word "inappropriate" has been removed from texts describing patients who are not in need of stents. Instead, these patient groups will be described as "rarely appropriate" for stent implantation. In unclear cases, the phrase "uncertain" will be replaced with "may be appropriate." Doctors are not required by law to use ACC-recommended language. However, these recommendations do carry weight with insurance companies, courts and regulators when issues arise with patients. According to some cardiologists, the change in language will minimize the stigma associated with elective stenting. In part, cardiologists believe that the negative stigma associated with this practice has been caused by a few rogue cardiologists who went too far. As of now, there are 700,000 coronary stent procedures that take place in the United States each year.