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Articles from 2012 In November

Boston Sci's New Stent Technology Enters Clinical Trial

Boston Scientific, a global medical device manufacturer based in Natick, Massachusetts, announced that it has successfully enrolled a patient in an Evolve II trial of the company's Synergy stent. The Synergy drug-eluting stent is used for the delivery of targeted medications. With data from the clinical trial, the company hopes to provide further backing for its approval applications in Japan and the United States. The company's Synergy stent is coated with a specialized polymer with bioabsorbable properties. The coating on the stent is designed to absorb everolimus, a potent chemotherapy drug. Once in the body, everolimus will be eluted front the stent for up to 90 days. According to a press release by the company, the clinical trial will comprise 2,000 patients and will last for at least five years. Kevin Ballinger is the interventional cardiology president at Boston Scientific. In prepared remarks, he said, "We continue to strengthen our drug-eluting stent portfolio with innovations like the Synergy system in an effort to increase the advanced treatment options available to physicians and patients." He continued, "This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader." The upcoming clinical trial of the company's Synergy drug-eluting stent follows CE Mark approval of the device. With approval by the European Union, the company plans to start a commercial rollout of the new stent technology as soon as 2013. References

This Week in Devices [ 11/30/2012 ]: Prosthetics Present Challenges and Innovation

Heart Devices Test Privacy Laws
While U.S. privacy laws guarantee patients access to medical records, no such laws exist for the information generated by medical implants. Data is sent to doctors and hospitals, but patients are being left in the dark. With private companies like Medtronic pushing to turn the collected data into a revenue stream, patients and patient advocates are fighting back, demanding access to their healthcare data [Wall Street Journal]
The Challenge of Having a Prosthetic Arm
We always hear about prosthetic limbs, but rarely do we hear about the challenges associated with them, both for surgeons and manufacturers as well as the patients themselves. The New York Times features a profile of Cpl. Sebastian Gallegos, an Iraq veteran, and his journey in learning to master his new prosthetic arm. He recently underwent a pioneering new type of surgery designed to make it easier to control his $110,000 prosthetic arm.
Museum to Build Biohacking Space
The Medical Museion in Copenhagen is undergoing a project to open up its space for body hackers. The project, “From Kitchen Sink to Museum: Doing and Debating Synthetic Biology,” will be made in collaboration with biohackers from the Copenhagen “maker space” Labitat. The museum has invited the biohackers to use the museum space as a laboratory where workshops and events will take place, thereby communicating concepts of biohacking. [Medical Museion]
Mind-Controlled Robotic Limbs Coming in 2013?
A group of volunteers is set to receive a new kind of prosthetic limb early next year. These new prosthetics will implant electrodes directly onto the amputee patients' bones and nerves allowing them to control robotic arm prosthetics with their minds. [Wired]

Implantable Silk Optics Dissolve, Triggering Tissue Regrowth in Their Wake

As one of the strongest-occurring natural materials, silk has long fascinated material scientists. The shimmering material has unique optical properties as well, thanks to the triangular prism-like structure of the fibers within it. Earlier this month, we covered the research conducted at Tufts University (Boston) and the CNRS Institut de Physiques de Rennes (France) that tapped the materials' optical properties for implantable sensors. 

The researchers have recently released more information on their research on silk-based implantable optics, and have pointed to a number of new biomedical applications for them, including drug delivery and monitoring, and simultaneous tissue engineering and photothermal therapy. An article in PNAS titled "Implantable, multifunctional, bioresorbable optics" explains how the technology, upon dissolution, spurs regrowth of native tissue. 

The microscopic image of a silk optical implant shows embedded gold nanoparticles. Image courtesy of Fiorenzo Omenetto

The researchers created the optical devices by pouring purified silk protein solution into molds for microprism arrays. The speed at which the implants dissolve can be controlled by regulating the water content of the protein solution. Upon drying, the solution dries and forms a material resembling reflective tape.

The researchers experimented with embedding the material with gold nanoparticles. (See image on the left.) When implanted in mice, these implants were illuminated with green laser light, thus heating the implants for use in thermal therapy to combat bacterial infections of destroy malignant cells. At the same time, the implant's optical properties enabled the scientists to monitor the process. 

The researchers also experimented with embedding the material with the cancer drug doxorubicin. The drug remained stabile even when the material was heated to 60° C.

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Reducing Costs, One Marker Band at a Time

Polymer marker bands are an alternative to traditional marker bands made from gold or platinum.

As companies struggle to meet the ever-growing demands of a changing healthcare system, the pressure facing medical device manufacturers to reduce costs is palpable. To cut costs while maintaining medical device functionality, Putnam Plastics Corp. (Dayville, CT) has developed a line of polymer marker bands for fluoroscopic illumination of catheter tips. An alternative to traditional marker bands made from gold or platinum, the new bands, according to the supplier, not only reduce the use of expensive materials but also eliminate the need to crimp or swage metal tips to catheter shafts.

"Gold and platinum are highly visible under x-ray, which is important for catheters," explains Dan Lazas, marketing director of Putnam Plastics. "Catheter tips require visibility for placement of balloons, stents, and other devices in the desired vascular location." However, such metal tips are expensive in a several ways. For example, the cost of precious materials is high and getting higher, Lazas says. "There is no getting around the fact that prices for precious metals have gone up."

In addition, the process used to manufacture and attach gold and platinum marker bands is expensive, Lazas notes. First, a multistep forming process is required to create seamless, small-diameter precious metal tubes that are then cut to specified band lengths. Then, the metal bands are often crimped or swaged to the catheter shaft employing specialized equipment. Besides being complicated, the process of securing gold or platinum bands to polymer shafts requires rigorous quality assurance to ensure that the bands remain in place during procedures.

In contrast to this multistep production process, Putnam Plastics relied on design for manufacturability to develop a continuous manufacturing technique that is substantially leaner, Lazas comments. The company's polymer marker bands for catheter tips are extruded into tubes from tungsten-filled polymers such as nylons, urethanes, or thermoplastic elastomers. Customized using the same polymer as the catheter shaft, the bands can be adhesive or thermally bonded to ensure secure assembly. "Like polymers offer the potential for improved bonding," Lazas says. "For example, thermal bonding of an 80% tungsten-filled Pebax marker band to a Pebax catheter shaft offers greater adhesion than if the band and shaft materials were dissimilar."

Featuring inside diameters ranging in size from 0.014 to 0.200 in. and walls ranging in thickness from 0.002 to 0.030 in., the new marker bands contain an unfilled polymeric outer surface similar to the catheter surface, providing a smooth band surface that minimizes trauma to blood vessels. In addition, the tungsten loadings ranging between 65 and 80% by weight meet radiopacity requirements, enabling surgeons to visualize the catheter features within the body to deploy a variety of medical devices.

New Films and Machinery Advance Medical Device Packaging

According to a recent purchasing study conducted by Pharmaceutical & Medical Packaging News, pharmaceutical and medical device packaging professionals value quality above all other considerations when searching for suppliers. But price is a close second. While quality and cleanliness reign supreme when it comes to demands placed on suppliers, the competitive medical device industry is compelling manufacturers to reduce costs wherever possible. And packaging is often a target.

Quality and Cleanliness
As converters work to devise new cost-saving materials and packaging formats, they are also fielding requests for more data and additional internal controls to ensure that they are maintaining quality standards. "FDA has significantly increased its resources for inspections and analysis since 2009," explains Nicholas Berendt, director of global medical market development at Sealed Air Medical Applications (Elmwood Park, NJ). "We are seeing more requests for multilevel documentation from our customers, and we are experiencing more frequent customer audits at our facilities as part of the increased trend in regulatory engagement."

Forming films from Printpack Medical eliminate the need to add costly secondary coatings to breathable substrates.

In addition to the heightened demand for more data and internal controls, demands for increased hygiene measures are increasing, Berendt notes. "We were getting customer requests to move from hair nets to full hoods and gowns in our cleanrooms. We are meeting this request." In addition, Sealed Air has upgraded its cleanroom facilities in order to achieve full ISO 13485 and ISO 14644-1 accreditation for its thermoforming operations.

Like Sealed Air, Printpack Medical (Atlanta) is upgrading all of its converting operations in Marshall, NC, to meet ISO Class 100,000 cleanroom standards, states Brad Walker, the company's vice president and general manager. "We see trends toward more FDA oversight and increased quality. Thus, we are making enhancements to Marshall. All converting equipment will be in the new cleanroom space." The facility will employ both automation and vision inspection systems in order to ensure zero defects and the integrity of the sterility barrier. To achieve these goals, the company is installing cameras to compare product to a standard and identify defects such as wrinkles and gels. The upgraded lines will also be able to eliminate deviations immediately.

Jumping on the cleanliness bandwagon, Perfecseal (Oshkosh, WI) is equally focused on quality. "We have reduced sources for particulates and have certified to cleanroom standards in most of our production areas," remarks Ed Haedt, the company's vice president of marketing. "Also, we have incorporated vision technologies to help catch and quarantine defective product before it gets to our customers." Thus, the company intends to concentrate on offering packaging products that achieve high quality levels while keeping costs in check.

The Material Makes the Package
To meet manufacturers' requests to cut costs, suppliers of medical device packaging are also striving to implement materials innovations. "Device manufacturers are facing tremendous cost pressures," says Michael Wollberg, sales manager at Printpack Medical. "It is more imperative than ever for us to deliver greater value through innovative products. Our new KwikBreathe pouches and DirectSeal forming films eliminate the need to add costly secondary coatings to breathable substrates."

Similarly, Perfecseal is developing stronger yet lower-weight nylon-reinforced film materials for medical device packaging applications. In contrast to monolayer or non-nylon-containing materials, these thinner films exhibit substantial light-weighting and downgauging properties. "An engineered approach to incorporating a high-performance polymer like nylon results in cost-effective films that have substantially higher durability than nonnylon materials," according to Haedt. "The term durability encompasses the overall performance of the film, including puncture resistance, repetitive flex-crack resistance, abrasion resistance, and other tensile-related properties."

Offering a range of pouches, Perfecseal is developing stronger yet lower-weight, thinner nylon-reinforced film materials for medical device packaging applications.

For example, the company's PerfecForm ICE forming film and Perfecflex QE bag film series 36670 offer some of the highest performance levels per unit thickness of any films in the industry, Haedt claims. Perfecseal has also developed Opalen MD, a proprietary nylon/polyethylene coextruded film designed for lighter-weight applications that can be run at high speeds. "Measuring 55 µm, this film is thin, but due to the nylon component, it has excellent puncture resistance and tensile strength," Haedt adds. The film can be sealed to such substrates as films, heat-seal coated and uncoated papers, and Tyvek.

Downgauging is a concern for other companies as well. Thus, Sealed Air's Latitude ML29C forming film enables medical device manufacturers to downgauge from other films by as much as 30%, Berendt comments. As a result, one of the company's customers has moved from a 10-mil EVA/Ionomer/EVA film to a 7-mil Latitude film to package a procedural kit that includes a syringe and other light consumables for the U.S. market. Because the film is thinner than competing films with equivalent or better mechanical properties, more material can be wound on 50-lb rolls, according to Berendt. Thus, the amount of downtime required for roll changeovers has been reduced, leaving more time for production.

Nexmark, another film offered by Sealed Air, is also being investigated for its savings potential. Incorporating a photochromatic additive that enables laser printing, the film eliminates the need for preprinted rollstock inventory, allowing shorter batch quantities and thereby reducing working capital, according to Berendt. In addition, the company is researching new resins and developing qualified alternatives during new product development. "Shortages of materials can happen, so we are establishing a safety net," Berendt explains. "Thus, we are building data on alternatives and filing it away in case there is ever the need to switch."

Manufacturing the Films
To manufacture films that meet the increasing demands for high performance and cost savings, packaging companies are using retrofitted or new film manufacturing technology that they hope will result in significant improvements. For example, Sealed Air has adapted its packaging equipment to accommodate Cryovac CT-301, a 30-gauge, microlayered shrink film offering 7.5 lb of impact strength. Used in shrink tunnels and on flow wrappers, this film can be used to collate different products and to provide tamper evidence. "We identified technology from a different industry and adapted it to work on our machines," Berendt notes. "This film offers a huge improvement in strength at half the thickness [of other films]."

Perfecseal is also adapting its equipment to meet the needs of new film technologies. For example, it is employing film-sealant technology to engineer medical-grade peel-opening systems that are designed to provide high seal strength and a fiber-free seal. Such systems are also designed to produce peelable, uncoated paper and medical-grade Tyvek. "We began by introducing our Clean Peel technology several years ago for Tyvek/film pouches and Tyvek/forming film for form-fill sealing systems," Haedt comments. "The success of that technology has been translated into more cost-effective paper/film options under the PaperLock system name."

While the company's ability to seal pouch-forming films directly to uncoated papers is not new, providing packaging materials with medical device-quality peel appearance and fiber-free peel seals at the industry target of 1-lb seal strength is new. "We combined our highly popular PerfecForm ICE film platform with this new sealing technology under the PaperLock CP system," Haedt notes. "This system can form a range of web thicknesses and paper thicknesses to cover a broad range of package performance requirements."

Not to be left behind, Printpack Medical has installed its first machine for supporting a full line of pouches, including Tyvek-to-film, paper-to-film, film-to-film, foil-to-foil, foil-header, and abrasion-resistant KwikBreathe pouches, Wollberg says. "This will complement the existing line of header bags, forming films, breathable top webs, high-impact polystyrene (HIPS) sheet, and film and foil laminates."

The Benefits of Employing Dip Molding in Medical Device Applications

An esophageal stethoscope contains a critical dip-molded component that is used to house the sensitive internal components and electronics required to monitor temperature and sound.

While molding process such as injection molding play a crucial part in the manufacture of medical devices and components, a lesser known, but no less important, technology is dip molding. From nasal cannulas, tubes, and Y-connectors to tissue-collection sacks, stent covers, and catheter balloons, the technique has distinct advantages over injection molding, as Chuck Brider, operations manager of Molded Devices Inc. (Riverside, CA), explains in the following conversation.

Dip molding is defined as a process by which a mold is dipped into a polymer to create a molded component. While plastisol--a suspension of PVC particles in a plasticizer--is the most commonly used dip-molding material because it is easy to process and affordable, other materials such as latex, neoprene, and urethane can also be used in dip-molding applications. In fact, latex is especially suitable for molded medical device components because it is more robust than plastisol and can tolerate a wider high-to-low temperature range. And in addition to its greater elasticity, latex can withstand more chemical abrasion than plastisol.

MPMN: What are the types of medical devices that would benefit from dip molding, and what is preferable about using dip molding in contrast to other molding processes for medical device applications?

Brider: The advantage of dip molding is that the tooling is inexpensive and that it can be used to perform short runs because of the low tooling costs. As a result, many parts can be produced for pennies apiece. The technique is also good for manufacturing thin-wall parts in a cost-effective way. Consequently, it can be used to manufacture such medical devices as balloons.
When using such materials as PVC or plastisol, dip molding can create devices with walls ranging in thickness from 0.008 to 0.010 in. When using latex, you can achieve wall thicknesses down to 0.004 or 0.005 in. Thus, the technology can make very thin-wall parts. In addition to the technology's ability to produce thin-wall components, it works with such shape-memory stretchable, elastic materials as latex and more-rigid materials such as PVC.

MPMN: Step by step, how is the dip-molding process performed?

Brider: Dip molding is a very simple process. First, the tool has to be heated. When that step has been completed, the tool is inserted into the plastisol or latex, and then it is placed in an oven for curing. Plastisol or PVC cures much faster than latex--minutes at the most. Latex, in contrast, cures at a much lower temperature and often has to be cured overnight.

MPMN: Why would a manufacturer decide to use dip molding as opposed to a more common technique such as injection molding?

Brider: It's a lot less expensive to use dip molding than injection molding. The equipment is pretty simple. For example, a fairly sizable oven is available for less than $50,000. In addition, water tanks, dip tanks, and tooling are relatively inexpensive. Moreover, tooling is usually available for prices in the high hundreds to the low thousands of dollars, depending on how many tools you need to make a part. While cheap injection-molding tools cost at least $10,000, expensive dip-molding tools cost perhaps $2000.

Memphis Is King as a Logistical Medtech Destination

For nearly 200 years, Memphis has been a crossroads for American distribution. In addition to boasting five Class I railroads and a strong road infrastructure, the city is known as the overnight and ground shipping capital of the world--thanks to FedEx, which is based in Memphis. The Southern metropolis is also the headquarters of several world-class medical centers, including St. Jude Children's Research Hospital, Methodist University Hospital, and Le Bonheur Children's Hospital. This concentration of logistics, infrastructure, and prestigious medical institutions has lured many medical device and pharmaceutical companies to the region.

Medtech Sets Up Shop
In the mid- to late 1980s, several medical device companies began to take advantage of the strategic business resources that Memphis had to offer. As a result, the city has become the second-largest center for orthopedic device manufacturing in the country thanks to a healthy base of medical centers, orthopedic-focused clinical practices, and research institutions. Indeed, one in every seven Memphians works in the bioscience sector, according to the Memphis Bioworks Foundation. Moreover, approximately 30% of the city's gross metro product comes from this sector.

"We've become the distribution center for the orthopedic industry," says Mark Herbison, senior vice president of economic development for the Greater Memphis Chamber. "We have the latest cut-off times for next-morning overnight delivery in the country." Because of its location, the metropolitan area is an ideal nodal point for time-sensitive products, from flowers to lab samples to orthopedic implants. Thus, if surgeons in Los Angeles or New York need a knee implant by the next morning, it will arrive on time if the orthopedic device company is resident in Memphis.

It is therefore hardly surprising that many OEMs and suppliers have set up shop in the city--including the Big Three manufacturers Medtronic, Smith & Nephew, and Wright Medical. "We're a major player in the industry and will continue to grow because we offer the lowest costs," Herbison remarks, comparing Memphis to California; Warsaw, IN; and the Minneapolis/St. Paul region. "We beat their costs by a third, and that's what is important to corporate America."

For leading OEMs such as Medtronic, which maintains its spinal and biologics division in Memphis, the city's location and distribution logistics present the biggest advantage. "Our company's Memphis distribution center delivered more than 150,000 surgical sets to operating rooms across the country last year," remarks Medtronic spokesperson Victor Rocha. That feat was accomplished thanks to Memphis's notable location and its logistics advantage. "The ability to hear about a critical surgery late in the afternoon from one of our sales reps in a hospital and to get our technology into the surgeon's hands the next day is crucial," Rocha adds.

According to data provided by the Greater Memphis Chamber, the Bureau of Labor Statistics Quarterly Census of Employment and Wages for 2011 estimated that medical equipment and supplies manufacturing comprised 17% of the entire manufacturing industry in Memphis. As of last year, there were 42 medical equipment and device manufacturers in Shelby County.

Employing more than 2000 people, UK-based Smith & Nephew is the largest device manufacturing company in Memphis, according to Herbison. In addition to serving as the site of the company's orthopedic division headquarters, Memphis is home to the company's North American distribution operations. Also calling Memphis home are a variety of smaller orthopedic companies--including Active Implants, TiGenix, Regenisys Orthopaedics, and Expanding Orthopedics.

On the supply side, Memphis is also home to a range of contract manufacturers, such as Orchid Design, Millstone Medical Outsourcing, Sandvik Medical Solutions, Engineered Medical Systems, Onyx Medical Corp, and Surface Dynamics. Based in Cincinnati, Surface Dynamics opened a facility in Bartlett, TN--part of the Memphis metro area--in 2009. With 14 employees and growing, the company was lured to Memphis by the cluster of medical device companies, specifically the Big Three, remarks president Leo Glass. "We're definitely committed to the long term for our group and to the Memphis area. Thus, we have plans to expand our operation significantly over the next five years."

Incentives, Grants, and Incubators
The existence of a medtech infrastructure was not the sole reason why companies such as Surface Dynamics were drawn to the Memphis region; other factors included economic and worker training incentives. For example, the state incentivizes companies against tax liabilities. A manufacturer or distributor coming into Tennessee can receive credits to offset the sales tax it has to pay on equipment or machinery, according to Herbison from the Greater Memphis Chamber. It also offers a significant franchise tax credit of up to nearly $5000 per new job created that can be carried on a company's books for many years. In addition, at the local level, property taxes can be reduced for up to 15 years, allowing firms to reduce their property tax liability by approximately 80%.

Besides government authorities, three groups play a role in facilitating medtech industry growth in the Memphis area. The nonprofit Memphis Bioworks Foundation unites public, private, academic, and government groups to expand the local bioscience industry. Dedicated to promoting long-term economic development and job creation, the Memphis Research Consortium is composed of local universities, medical device companies, hospitals, foundations, and other businesses. And the nonprofit organization Life Science Tennessee--whose members include universities, device companies, research institutions, economic development groups, government, and industry associations--seeks to grow the life science industry at the state level through advocacy, education, partnerships, and economic and workforce development initiatives.

Memphis not only helps established companies settle in the city, but it also promotes the development of startups. For example, startups can receive $100,000 grants from the city's Zero to 510 medical device accelerator program, which touts itself as the first cohort-based medical device accelerator in the country. The program begins with a 90-day period that focuses on mentorship, market validation, proof-of-concept, business planning, and prototype development. After presenting their products to investors and being selected to receive funding, the startups then spend the next 90 days developing their prototypes.

Startups find support at the University of Tennessee (UT)-Baptist Research Park, a major force in Memphis that is positioning itself as a world-class incubator for bioscience companies. Scheduled for completion in 2013, the 13-acre park will feature several labs, office buildings, an academy for training researchers using cadavers, and a UT Health Science Center College of Pharmacy building.

Attracting a Skilled Workforce
Like other U.S. regions, Memphis is not immune to the shortage of skilled labor. "It's the number one issue at our Chamber of Commerce and in our city right now--training manufacturing-type skilled employees in our community," Herbison comments. In an effort to attract young skilled workers that are either college or vocationally trained, various organizations in the region are hard at work promoting Memphis as an up-and-coming center. "We're going to have 1000 jobs a year over the next five years in the manufacturing sector that are going to be available in the community," Herbison says.

Historically, the Greater Memphis Chamber has worked with the Memphis Workforce Investment Network and Southwest Tennessee Community College to implement customized training programs for local medical device companies, Herbison notes. As part of this effort, the Big Three device companies have donated machining equipment that can be used for the training program. Other institutions involved with the Workforce Investment Network include Baptist Memorial College of Health Sciences, the University of Memphis, and vocational schools. As a result of these efforts, the 24 Memphis-area colleges and universities that offer bioscience programs produce some 2250 bioscience graduates each year.

There are also several programs and institutions in the Memphis area that provide college and high school students with training to enter the bioscience sector. They include the Memphis Academy of Science and Engineering, which focuses on math and science from grades 6 through 12; East High School, which offers optional engineering and health sciences programs that focus on careers in engineering, design, technology, healthcare, and biotechnology; and Kingsbury High School, which provides biotech and medical science courses, as well as mentors and internships for students.

As device companies and suppliers face pressures to meet customer needs at a faster rate and lower cost, Memphis serves as an appealing location to complete the job. The strong logistical infrastructure combined with the growing and vibrant bioscience cluster benefit both established and startup companies. Add to this the fact that Memphis was named one of the top 10 most affordable cities in North America and Europe to run a biomedical business, and the city on the Mississippi River is sure to continue to attract more medical device companies for years to come.

Manufacturing Systems Today: Machining Equipment

Modular work-holding systems
Combining the characteristics and performance of a dedicated fixture in a modular platform, Triag work-holding systems from Advanced Machine & Engineering/Hennig Inc. use compact clamp, power clamp, and microclamp technology to hold very small to midsize parts in high densities. The systems are designed to facilitate part changes for fast retooling. Innovative clamping designs minimize interference so that machine spindles have full access to workpieces even in high-density applications. Access is especially good for five-axis machining when the manufacturer's five-axis clamp is used. These modular work-holding systems offer many clamping options for medical device machining operations.
Advanced Machine & Engineering/Hennig Inc.

Laser-cutting machine
The unibody-chassis Meta platform for laser-cutting machines from Coherent Inc. is intended to enhance performance and ease of use while offering fast throughput and high accuracy. The rigid single weldment gives the system good mechanical stability, resulting in fast cutting speeds and high positioning repeatability. Measuring 1.25 × 1.25 mm, the cutting bed on laser-cutting machine tools using this platform is large enough to accommodate standard European sheet sizes. When configured with a 1-kW CO2 laser, the flexible system is able to process a range of metals and such nonmetallic materials as plastics, wood, fabrics, leather, paper, and thin films. In addition, it can cut 3-mm stainless-steel, 2-mm aluminum, and 6-mm mild steel sheet. The platform's control system has been upgraded through the introduction of an industrial-style operator interface mounted on the side of the chassis, containment of all interface cables within the machine assembly, a multilingual software interface, and improved system automation.
Coherent Inc.

Miniature thread mills
Suitable for medical device manufacturing applications, Emuge Corp.'s productivity-enhancing miniature solid-carbide thread mills can machine difficult materials, such as stainless steels, titanium, K-Monel, Hastelloy, and Inconel. Available in versions with an overall length of 15/8 in. and a shank diameter of 1/8 in. or a length of 2½ in. and a shank diameter of ¼ in., the mills offer thread lengths ranging from 0.125 to 0.415 in. and cutting diameters ranging from 0.045 to 0.167 in. Fourteen thread sizes between #0-80 and #8-36 are supplied. The three-flute mills are suited for high-volume output, while a one-flute version of the smallest-diameter mill is also available. To maximize efficiency, the series design eliminates the possibility of tap breakage; hand-tapping in full bottom-threading applications is unnecessary. The same mills can be used to thread both through and blind holes.
Emuge Corp.

High-speed machining center
The CNC C 22 U dynamic high-speed machining center for the production of complex medical device components is available from Hermle Machine Co. with the easily adapted PW 150 pallet changer. The automated system consists of a numerically controlled drive unit and a turning unit with a double gripper, both of which are positioned to the left of the machine to allow free access to the working area. The double gripper can be used to simultaneously move two pallets, each having a transport weight of 150-kg. Alternatively, it can move one pallet weighing as much as 250 kg loaded. The maximum space for part processing measures 400 mm in diameter and accommodates workpieces as tall as 370 mm. In its standard configuration, the automation system can handle up to six pallets, with additional storage capacity for as many as 11 pallets. It is suitable for use with one machine, or it can be incorporated into a multimachine manufacturing cell.

Hermle Machine Co.

Water-jet machining center
Employing advanced abrasive water-jet technology, the Omax 60120 JetMachining Center from Omax Corp. is equipped with a high-efficiency EnduroMax pump, which is available in a variety of horsepower options. The center is also available with such accessories as a motorized z-axis for precise nozzle positioning. The bridge-type water-jet machining center leaves smooth surface finishes after cutting. In addition, it does not require tool changes or complex fixturing of workpieces, which can start with stock having a footprint as large as 5 × 10 ft. The system features x-y travel of 126 × 62 in. and comes with proprietary automation software that calculates tool-path velocity at better than 2000 points per inch. Based on a CAD drawing or DXF file, the equipment can be used to machine parts from such materials as metals, plastics, glass, ceramics, and composites. The clean, safe water-jet machining process does not use noxious gases, liquids, or oils.
Omax Corp.

Outsourcing Outlook on Full-Contract Manufacturing

Full-contract manufacturers enable medical device OEMs to achieve less-complex project management, according to Kevin Allison, business development manager at Crescent Industries Inc. (New Freedom, PA).

MPMN: What technical and logistical benefits does the medical device OEM derive from working with a full-contract manufacturer?
Allison: One benefit that the OEM gains by working with a full-contract manufacturer is less-complex project management. When a medical device OEM partners with a contract manufacturer, the supplier holds the responsibility for the project from beginning to end. As a result of this relationship, medical device products achieve speedier time to market. Another benefit that OEMs derive from partnering with contract manufacturers is that they can collaborate on all manufacturability issues, from design and prototyping to product verification and performance. By working with a single company starting with the design phase, the OEM can ensure that the contract manufacturer adheres to design principles and best practices, enabling the partners to ensure design continuity and control over the course of the manufacturing process. Consequently, the OEM can be certain that components will meet specifications and expectations.

MPMN: What technical expertise should a medical device OEM demand of a full-contract manufacturer?
Allison: The medical device OEM should demand that a full-contract manufacturer adhere to such standards as ISO 13485:2003 and CGMP guidelines. Along with the ISO quality certifications, contract manufacturers should be able to provide consistent and repeatable products by utilizing scientific and decoupled injection molding processes. In addition, contract manufacturers should ensure that their processes are validated so that the OEM's products meet the required qualification and validation procedures. These validation processes are beneficial to the OEM because they help prevent the manufacture of products that do not meet specifications.

MPMN: How are the demands on full-contract manufacturers changing, and what should OEMs and their partners do to keep pace with changing standards and technologies?
Allison: With increased emphasis on production qualification and validation, the OEM must ensure that the full-contract manufacturer acquire upfront information about the requirements, end use, and classification of the product. With an understanding of these expectations and a scientific approach to quality solutions, the supplier can identify key variables so that products are manufactured consistently to OEM expectations. These quality solutions include installation qualification, operational qualification, performance qualification, capabilities study, gage repeatability and reproducibility, process failure mode effects analysis, and control plans.

Manufacturing and cleanroom device assembly services
A full-service contract manufacturer offers injection molding, radio-frequency welding, silk-screen printing, solvent bonding and leak testing, and tipping and punching services. Operating an ISO 9001:2000- and ISO 13485:2003-certified production facility, Angiplast Pvt. Ltd. also performs physicochemical, sterility, pyrogen, and toxicity testing in an in-house laboratory to applicable USP and ISO standards. Additional capabilities include EtO sterilization. Most of the company's medical devices carry the CE mark. The supplier develops production processes, manufactures custom products to specification in short runs and mass-production volumes, and packages medical devices in pouches or kits.
Angiplast Pvt. Ltd.

Contract manufacturing of finished products
A full-service supplier of comprehensive engineering, manufacturing, and assembly solutions, ISO 13485-certified and FDA-registered Inteprod LLC partners with medical device makers to develop and produce electromechanical devices, diagnostic systems, and disposables. Its service range comprises transfer to manufacturing, quality assurance and compliance, materials sourcing, production planning, manufacturing control, and finished-product assembly. The company's multidisciplinary technical staff provides long-term sustaining engineering to identify, support, and implement design changes, engineering upgrades, and product and process quality and cost improvements. Fully integrated manufacturing solutions entail product safety elements, product and process verification, design for manufacturing, design for cost reduction, and process control documentation.
Inteprod LLC

Electronic manufacturing services
Suntron Corp. provides integrated, full-contract electronic manufacturing services and embedded computing systems. The company's capabilities include box build of Class I to Class III devices, PCB assembly, and large-scale system integration. In addition to ultrasound and endoscopy systems, cancer monitoring and diagnostic systems, neurostimulation devices, electrosurgical devices, orthopedic surgical devices, and other safety-critical products, the service provider produces patient monitoring and connectivity systems and hospital asset tracking systems. Class 10,000 and Class 100,000 cleanroom installations enable the FDA-registered and ISO 13485-certified company to produce critical assemblies that meet medical device industry standards.

Suntron Corp.

Diagnostic and drug-delivery device manufacturing services
A contract manufacturer of medical diagnostic and drug-delivery devices, Medisize helps select appropriate materials, manufacturing processes, and packaging for OEM customers. Its turnkey competencies extend across several disciplines, such as product design and development, in-house toolmaking, injection molding, insert molding, silicone molding, injection blow molding, film welding, assembly, packaging, and sterilization. All manufacturing is performed in Class 10,000 cleanroom facilities housing 132 injection molding machines and 27 injection blow molding machines.

Full-contract manufacturing of Class I, II, and III devices
Certified to ISO 13485:2003 standards, a full-contract manufacturer performs custom injection molding services in an ISO Class 8 cleanroom and assembly and packaging services in an ISO Class 7 cleanroom. Crescent Industries Inc.'s molding area accommodates up to five vertical/vertical or horizontal injection molding machines that are used to manufacture Class I, II, and III medical devices, including surgical equipment and disposables. Relying on automation, scientific injection molding, and lean manufacturing principles, the company also offers design and development, mold-building, and value-added services.
Crescent Industries Inc.

With First Product Offerings, Scanadu Hopes to Reboot Home Healthcare

With First Product Offerings, Scanadu Hopes to Reboot Home Healthcare

Such a scenario could be not far off. A company called Scanadu (NASA Ames Research Center, Moffett Field, CA), which is the most prominent firm vying for the $10 million Qualcomm Tricorder X Prize, has announced its first product offerings: ScanaFlu, ScanaFlo, and the SCOUT. The firm is touting the tools as the “biggest innovation in home medicine since the invention of the thermometer.”

 The SCOUT device will be able to measure vital signs in less than 10 seconds.   

The ScanaFlu, a saliva tester that can be used in conjunction with a smartphone to determine if you have strep A, influenza A, influenza B, adenovirus, or RSV.

The ScanaFlo, a urine testing device that can detect pregnancy complications, preeclampsia, gestational diabetes, kidney failure, and urinary tract infections. At present, there is no health pregnancy test, said the company’s co-founder and CEO Walter de Brouwer in an interview with TechCrunch. “This is a test that not only checks to see if you are pregnant but also checks for the complications of pregnancy or checks for liver or kidney failure, dehydration, or gestational diabetes.”

Scanadu's CEO de Brouwer demonstrates on TechCrunch how the SCOUT would measure vital signs—by pressing the device with the thumb and forefinger against the temple. 

The SCOUT, which is expected to debut at the end of 2013, is a cloud-connected vital signs monitor that will cost less than $150. Within less than ten seconds, it can assess pulse transit time, heart rate, ECG, temperature, heart rate variability, and blood oxygenation. Walter de Brouwer explained in an interview with TechCrunch that device had to work quickly to be valuable in a “Twitter-ized world.”

The technology behind the devices draws on electrical and mechanical engineering, using sensors and electrodes. The company relies on imaging and sound analysis, molecular diagnostics, data analytics and algorithms to create an accurate summary of your health in real time. 

Since Scanadu was founded in 2010, it has received more than $6 million in seed funding. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

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