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    [title] => Compliance and Quality Part 1—Following the Rules Isn't Enough to Win
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    [summary] => In the game of compliance versus quality, avoiding penalties doesn't ensure success.
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    [body] => For further insights on the topics and concepts illustrated in this infographic, check out "Can You Sell Poor Quality Devices in Compliance with Regulations? An examination of the often-misunderstood relationship between quality and compliance," by Daniel R. Matlis, the president of Axendia Inc.

Also see Infographic: Compliance and Quality Part 2—Food for Thought


 
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2016-04-11 00:00:00 [updated_at] => 2017-07-06 13:58:36 [last_updated_author] => 197901 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["250071","249616","247985","247546","246736","244815","243465","243454","243443","242799","242597","242248","240293","238770","238641","238357","238355"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2722 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => Infographics [short_tag] => Infographics [class_name] => [display_view] => view_infographics [list_view] => [slug] => infographics [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 246 [formattedTag] => Infographics ) [viewURL] => /contents/view_infographics/2016-04-11/infographic-compliance-and-quality-part-1-following-the-rules-isnt-enough-to-win/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238355 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-01-01 [author_name] => {"name":"Michael Barbella","title":"Managing Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141440 [primary_image_old] => [slider_image_id] => 141440 [banner_image] => 0 [title] => Bridging the Digital Divide [short_title] => [summary] => EMS providers with DFM expertise and service flexibility are best suited to help their medtech partners achieve success. [slug] => bridging-the-digital-divide [body] => Kevin J. Tracey decided to become a neurosurgeon when his mother died. He was 5 years old at the time.

Too young to truly comprehend the loss, Tracey sought solace with his maternal grandfather, then a pediatrics professor at Yale University. He wasn’t looking for kind words from the man, a shoulder to cry on, or even a peck on the cheek.

All he wanted was an explanation.

“I climbed onto his lap and asked what happened,” Tracey recalled to The New York Times in a 2014 interview. “He [grandfather] explained that surgeons tried to take it [brain tumor] out but couldn’t separate the tumor tissue from the normal neurons. I remember saying to him, ‘Somebody should do something about that.’ That was when I decided to be a neurosurgeon. I wanted to solve problems that were insolvable.”

Tracey’s personal vendetta against the unsolvable would eventually define his medical career, beginning with the 1985 death of an infant burn victim at New York Hospital. Accidentally doused with boiling pasta water, the girl died suddenly in Tracey’s arms just a few days before her scheduled discharge, and only 24 hours after her first birthday.

The case haunted Tracey for years. He found himself wrestling with a familiar question from childhood: What happened?

He wanted an explanation. Again.

This time, however, Tracey answered his own question. He suspected sepsis, a condition caused by the human immune system’s overwhelming and life-threatening response to an infection. The illness can lead to tissue damage, organ failure, and ultimately, death.

Confounding Tracey’s theory, though, was the lack of bacteria and/or signs of infection anywhere in the victim’s body upon death.

“The more I looked into the problem, the more I realized that basic science lacked a fundamental understanding of why septic shock occurs,” Tracey, now president of The Feinstein Institute for Medical Research (Manhasset, N.Y.) and professor of molecular medicine and neurosurgery at the Hofstra Northwell School of Medicine, told a TEDMED audience last May. “Thirty years ago, I decided to go into the lab and study that problem and my labs have been pursuing that question ever since. What we found changed the way the world thinks about how the body responds to infection.”

Indeed, Tracey’s research changed the way the medical world thinks about organic infection defenses. Specifically, he discovered an interface between nerves and the immune system, disproving a deep-seated scientific consensus that long regarded communication between the two impossible. The conduit for this interplay is the vagus nerve, which helps control and regulate inflammation. Through a series of experiments, Tracey showed that the human nervous system works similarly to a computer terminal, through which commands can be delivered to stop problems like acute inflammation before it begins, or repair the body after an illness.

Tracey’s efforts to better understand the body’s immunological responses has helped establish the emerging new field of bioelectronics, a promising area of medicine that has proven successful in treating acute and chronic immune system disorders (i.e., rheumatoid arthritis, diabetes, psoriasis, inflammatory bowel disease, multiple sclerosis, heart disease, etc.).

The idea of interrupting the vagus nerve-brain conduit with electrical pulses is not an entirely new concept. Vagus nerve stimulation has been used since 1997 to control epileptic seizures and has also been effective at treating drug-resistant cases of clinical depression. But advancements in immunology—due largely to Tracey’s groundbreaking research—are prompting clinicians to test the technique on other difficult-to-manage diseases.

And the results have been encouraging.

Clinical trial subjects implanted with bioelectronic nerve stimulators in their necks have reported significant improvements in rheumatoid arthritis and Crohn’s disease symptoms. Arthritis sufferers, according to study data, experienced fewer swollen joints and pain, while several Crohn’s disease patients achieved complete remission.

Such notable turnarounds are inspiring quests for additional therapies as well: Purdue University researchers, for instance, are investigating bioelectronic therapies for epilepsy, a brain disorder that costs the U.S. healthcare system $15.5 billion annually. Johns Hopkins University scholars, on the other hand, are studying the ways nerve signals affect obesity, diabetes, and gastrointestinal-motility disorders. “What we’re doing today,” Johns Hopkins Medicine and Neurosciences Professor Jay Pasricha said, “is like the precursor to the Model T.”

Only this Model N has more savvy backers.

Last summer, pharmaceutical giant GSK (GlaxoSmithKline) and Verily Life Sciences LLC (formerly Google Life Sciences) formed a company specially tasked with researching, developing, and commercializing bioelectronic therapies. The two partners will contribute 540 million British pounds ($714 million) over seven years to operate Galvani Bioelectronics, aptly named after the 18th century scientist best known for his experiments animating severed frogs’ legs with jolts of electricity.

GSK considers the joint venture with Verily a natural “next step” in its four-year crusade to establish a firm foothold in bioelectronic medicine. The company has invested roughly 45 million euros ($50 million) since 2012 on bioelectronic technology, including a million-dollar prize in 2013 to encourage research into “electroceuticals.”

GSK first unveiled its bioelectronics ambitions three years ago in the journal Nature, and believes it is ahead of its big pharma rivals in developing medical treatments to use electrical impulses rather than traditional chemicals or proteins. Galvani executives expect the first bioelectronic devices to be ready for government inspection in six years.

“This is an ambitious collaboration, allowing GSK and Verily to combine forces and have a huge impact on an emerging field,” Brian Otis, chief technology officer at Verily, said when the partnership was announced. “Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturized technologies.”

Not to mention electronics manufacturing and design prowess. As electrophysiology and neuroscience yield promising new treatments for age-old diseases, companies like Galvani will need to work closely with electronics manufacturing services (EMS) providers to bring their products to market.

“The medical device industry is at a point of significant change,” noted John Carlson, president of Flex Medical Solutions, a division of Flex Ltd., a global provider of sketch-to-scale design, engineering, manufacturing, supply chain insight, and logistics services to various industries, including medical. “There’s a growing recognition that in order for medtech companies to compete, they’re going to have to be much better at collaboration and partnership in certain areas than they’ve historically had to be. We’ve seen ongoing consolidation in the industry, and as a result, companies’ portfolios have become bigger. Consequently, the number of products they’re having to produce has grown almost exponentially. Therefore, the consolidation, the bigger portfolios, and the products’ naturally long lifecycles have forced companies to look at partnering with EMS suppliers in a very different way than in the past.”

One alternate view is beget by a reassessment of core capabilities. Companies with diverse product portfolios are almost never adept in all markets and/or healthcare technologies in which they operate, and thus must outsource with trusted partners to remain competitive.

Privately held biotech firm Ichor Medical Systems adopted this approach in collaborating with Flex on its TriGrid DNA Delivery System, an electroportation device used to deliver DNA vaccines and treatments for various diseases. TriGrid uses electrical fields to increase DNA drug delivery efficiency up to 1,000-fold as compared to conventional injection. The product is comprised of a small, hand-held device that contains a syringe needle and four recessed electrodes arranged in a diamond shape around the central syringe. The design, according to Ichor, is necessary to encompass the tissue in which the drug is administered.

Ichor turned to Flex to incorporate multiple layers of switches in the device, including mechanical, senseless rotational, and optical for accurate drug dose delivery. Flex also developed a special algorithm to compensate for minor deviations in delivery. 

“There’s a growing awareness across large and small companies that the pathway to success is collaborative development or partnerships,” Carlson said. “The old outsourcing model of ‘I give you the spec and you go make this’—those kinds of relationships don’t work out well on the OEM side or the EMS provider side. The collaborative efforts tend to be the best ones, and we’re seeing increased recognition from large and small companies of the need to partner.”

That need has partly been driven by the advent of digital health and the shift from service- to value-based reimbursement models. Digital health entrepreneurs are approaching medicine largely from a data perspective, crafting personalized solutions based on new ways of gathering, viewing, manipulating, and analyzing patient information. Their strategies are blurring industry lines and inspiring new technologies like wearable health devices and activity trackers that put data into users’ hands.  

Among the flood of wearables saturating the market are two wireless smart patches from Silicon Valley startup VitalConnect—the VitalPatch, a disposable biosensor developed in partnership with Flex, and HealthPatch MD, a reusable cardiac monitor.

Both patches continuously measure heart rate, respiratory rate, heart rate variability, skin temperature, posture, and step count, and they’re powered by zinc-air batteries that can last up to four days before requiring replacement. Both devices also are designed to detect falls.

The patches have been certified and cleared for use in the United States, European Union, Japan, and Canada. They are produced in different adhesive grades based on activity and perspiration levels.

“From a medical standpoint, historically we’ve been partnering [with companies] on the manufacturing end,” Carlson explained. “But more and more, we’re helping customers understand how partnering on the innovation side of things can really help them gain a competitive differentiation in the marketplace and allow them to move much faster than they would otherwise do on their own. Many of our newest engagements have really been on the innovation side of things, where we’ve helped customers move into new technology spaces and bridge the different industries much faster and better than they would have without our help.”

Crossovers can be overwhelming, though. Medtech firms unfamiliar with the consumer space are often dumbfounded at the fast pace of product development and amount of risk-taking associated with new innovations. Medical devices require significant understanding of the target audience and are subject to stringent regulatory scrutiny whereas consumer products are more nimble and can be commercialized in a matter of months.

Such an abbreviated product development timeline can be a major stumbling block for healthcare companies traversing the consumer market. Incorporating wireless connectivity into a medical device requires knowledge of WiFi, Bluetooth, radio-frequency identification, near-field communications, and other connective technologies, as well as IEEE standards for information technology and telecommunications/information exchange.

New York City-based startup AdhereTech Inc., for example, leveraged the wireless communications expertise of full-service design firm Intelligent Product Solutions (IPS) to develop a smart, wireless pill bottle that electronically reminds patients to take their medications and alerts caregivers to missed doses. The company estimates that medication non-adherence costs the United States roughly $100 billion and contributes to 100,000 deaths annually.

AdhereTech’s Smart Pill Bottle is basically a standard drug vial with a cellphone radio and prescription inside that occasionally beeps and lights up to remind its owners to take their medications. The bottle requires no syncing or programming, and its battery can last up to 90 days on a full charge.

AdhereTech executives chose wisely in partnering with IPS on the Smart Pill Bottle, as they tapped into a knowledge base of former Symbol Technologies and Motorola experts with experience in all forms of wireless communications—from low-level languages like Zigbee, Bluetooth, and near field to the longer-range protocols of WiFi, GPS, and wide area radio communications.  

Certainly, electronics design and wireless communication expertise are important ingredients for any EMS outsourcing partnership, but they comprise only a small part of the full recipe for success. Quality, of course, is at the top of every device manufacturer’s list of selection criteria, but it’s also imperative to consider location, product complexity, test procedures, circuit board cleanliness, and cost containment, among other factors.

Geography can easily become a deciding factor, depending on whether companies want to manufacture a product near their headquarters or somewhere within the distribution market. “We are seeing increased interest in regional manufacturing as an outsourcing strategy,” said Curtis Campbell, vice president of West Coast sales for SigmaTron International Inc., a full-service EMS provider based in Elk Grove, Ill. “We have U.S. customers that select a specific U.S. or Mexico facility for its proximity to their engineering team or manufacturing locations. In China, we’ve seen increased interest from medical customers for manufacturing support in China to support sales in China. We’ve added ISO 13485:2008 certification to our Suzhou, PRC facility to support that, and we are expanding our support capabilities in the United States as well.”

Naturally, cost is a major consideration when determining location. Manufacturing a product far from home—on another continent or a different hemisphere, perhaps—is significantly more expensive than local assembly, particularly when problems arise. Long-distance production can also be complicated by conflicting time zones, language barriers, and divergent cultures.

Costs can be reasonably mitigated, though, through design for manufacturability (DFM). Incorporating this proactive technique from the start of the product development process not only helps control expenses, but also improves device reliability and sustainability.

“Medical device OEMs have a good knowledge of electronics but they generally don’t have the capability to make a device manufacturable,” said Dave Busch, vice president of Medical, NEO Technology Solutions, at NEO Tech, a Chatsworth, Calif.-based supplier of electronic product design, engineering, and manufacturing services for the medical, defense/aerospace, and industrial markets. “The OEM’s expertise is in leveraging technology to create a solution to a medical problem. The contract manufacturer’s expertise is in making the solution manufacturable.”

Indeed, contract electronics manufacturers can help their partners ensure that designs are practical to make from a cost or materials standpoint, and that those solutions suit the end user. In addition, a closely integrated team can reduce the risk of a “silo” approach and an overemphasis of any one element, while other design considerations are overlooked.

EMS providers can offer the most value to their partners, however, through component obsolescence management. An inevitable and unavoidable by-product of the digital health revolution, antiquated parts can add cost and complexity to any project. At fault is medtech’s long product development lifecycle, which can hamper companies’ abilities to incorporate the latest hardware/software in finished devices. Upgrades can further complicate the development process, as product changes or modifications typically require regulatory recertification.

Component obsolescence can be managed in various ways, though many EMS providers have chosen to tackle the challenge through component monitoring software programs. Such courseware can help identify the timing of part antiquity as well as inventory levels and source reduction.

“When customers design a product, they put a bill of materials together. We take that BOM and buy all the parts and put everything together. Many times, we’ll get a bill of materials and go out to buy the part only to find out that one of the parts is obsolete or will be obsolete in the next year. That already puts you behind the eight ball,” said Michael Goeringer, president of Elk Grove Village, Ill.-based Arc-Tronics Inc., a designer and manufacturer of custom-printed circuit boards, and electromechanical and cable/harness assembly products. “We have some software tools to help customers in this area. We load up their BOM, it goes out to the Web, and it does a risk analysis. There’s an algorithm built into the software program that calculates when a particular part will become obsolete. The report will say, ‘This part is not recommended for design,’ or ‘This part will be obsolete in two years.’ We can help customers avoid these problems if we get involved with them up front. We’re building MRI machines—they’re expensive pieces of equipment that are going to be around for a long time. You need to be able to support those machines for 20 or 30 years. You can’t sell a machine for seven figures and two years later say, ‘That part went bad and there’s no replacement for it.’ That’s not going to be good for the customer. Obsolescence is a huge factor in the design of a product.”

So is cybersecurity. Earlier this year, the U.S. Food and Drug Administration (FDA) confirmed hacking vulnerabilities in St. Jude Medical Inc.’s pacemakers and implantable heart defibrillators, though regulators insisted the hacking risk never endangered patients.

Nevertheless, the confirmation was unsettling, as it highlighted the growing risk posed by mobile health devices and wireless communication networks. A Brookings Institute report issued last year detailed the disturbing extent of that risk, finding that 23 percent of all data breaches occur in the healthcare industry, and nearly 90 percent of healthcare organizations experienced a data breach between 2013 and 2015, costing the industry $6.2 billion.

In late December (2016), the FDA released cybersecurity recommendations for medical device manufacturers, suggesting that device makers monitor their devices and associated software for bugs, and patch any problems that occur.

“One of the challenges EMS providers face in designing connectivity and intelligence into medical products is to have effective cybersecurity management,” noted Wayne Meng, founder, president, and CEO of Sanbor Medical, a medical device contract manufacture company in Allentown, Pa. “Developing a set of cybersecurity control [measures] should include limiting access to devices through the authentication of users, ensuring the data transfer to and from the device using encryption methods, and implementing features that allow for security compromises to be detected, recognized, logged, timed, and acted upon during normal use.”

***
Kevin Tracey envisions a future without drugs.

In that world, medicine and Mother Nature speak the same language, courtesy of infinitesimal microprocessors that can communicate with and control the body’s nervous system. “A patient gets a device implanted once for disease, and they’re done,” he fancied to the Times. “No prescriptions, no medicines, no injections. That’s the future...”

To achieve that future, though, Tracey will need the support of electronics manufacturing service providers, who hold the key to deciphering the body’s biological brogue. Collaborating with these companies can help turn Tracey’s vision into a reality, as they possess both the expertise and service flexibility to become trusted partners.

“Many companies are expert at understanding the market need, but not experts in manufacturing. We continue to see a desire for medical device manufacturers and many of our other customers to look for service delivery flexibility,” said Adrian Nishimoto, operations manager at Spectrum Assembly Inc., a vertically-integrated contract manufacturing firm in Carlsbad, Calif. “San Diego is a medical product development hub and we see many startup clients who have very specific support needs that don’t always fit the typical electronics contract manufacturing model. There is often a ‘gap’ period where they aren’t doing high enough volume manufacturing to attract larger EMS companies, but the complexity of their needs goes beyond what most job shops can offer. We’ve found our ability to listen to their requirements and then fill the gaps in their documentation and materials strategy, plus optimize their assembly processes addresses that issue well.”  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-01-30 11:11:38 [updated_at] => 2017-01-30 11:11:38 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["246122","244421","240724","245199","240267","243461","241062","245205","239928","243471","239966","236614","28588","236105","235477","237340","239865","238371","238356","238377","236746"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238357 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-01-01 [author_name] => {"name":"Mark Crawford","title":"Contributing Writer"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141443 [primary_image_old] => [slider_image_id] => 141443 [banner_image] => 0 [title] => A Laser Focus on Precision [short_title] => [summary] => Machining specialists invest in the accuracy of lasers while taking advantage of improved traditional options. [slug] => a-laser-focus-on-precision [body] => Medical devices are increasingly complex and require tighter tolerances and finer finishes, especially for cardiovascular and orthopedic surgical applications. To manufacture these products, medical device manufacturers (MDMs) are constantly asking their contract manufacturers to push the limits of technology—for example, advanced micromachining methods can now achieve features as small as a single micron (for comparison, the diameter of a human hair is 75 microns).

“The machining/laser process market is growing, spurred by the need for innovative advanced manufacturing technologies to fabricate micro products with complex features,” said Mike Adelstein, president and CEO of Potomac Photonics, a Baltimore, Md.-based contract micro fabricator for the medical device, biotech, and electronics industries. “More end-users are focusing on the design stage and outsourcing the prototyping and production processes to contract manufacturers.”

Demand for larger machining/laser processing is also expanding, with existing product lines growing at a healthy rate and innovative new product development programs continuing to “drive quick-turn prototyping and short-run jobs—for example, new clinical applications of robotic surgery,” said Herb Bellucci, CEO of Pulse Systems Inc., a Concord, Calif.-based contract manufacturer that provides precision metal fabrication to the medical device industry.

Although business is good for machinists and contract manufacturers, they are feeling plenty of pressure from OEMs to increase their capacities and capabilities—not just for traditional processes, such as Swiss machining and electrical discharge machining (EDM), but also advanced micromachining and laser processes. Forward-thinking companies realize it is vital to invest in these technologies so they have the tools and know-how to build the increasingly complicated product designs their customers want. For example, Peridot Corporation, a Pleasanton, Calif.-based medical device contract manufacturer, recently purchased and placed into service more than $1.5 million worth of new equipment in 2016, including three new fiber laser systems, to meet growing demands of its clients.

“We can now achieve laser kerf widths of 25 microns with our new laser cutters,” reported Patrick Pickerell, Peridot’s president.

As medical devices get smaller and carry more complexity and functionality, MDMs are turning toward laser processing, especially for technically challenging applications that fall outside the capability boundary of traditional mechanical processes. As a result, laser processing is becoming one of the fast-growing markets in the micro manufacturing sector. Resonetics, for example, a Nashua, N.H.-based provider of laser micro manufacturing services for the medical device industry, reports a sustained double-digit growth in laser micro manufacturing as OEMs continue to globally outsource manufacturing and focus their attention on their core competencies.

The trend of consolidation also continues as mid-size players are purchased by larger organizations. “This consolidation is leaving behind a vacuum of laser core competencies, because strategic acquisitions have diluted capabilities,” said Glenn Ogura, senior vice president of market development for Resonetics.

Laser Processes Reduce Cost
OEMs seek continuity, consistency, and speed when transitioning a project from prototyping to production. Not only do they want faster turns for prototyping and faster production speeds, they want lower costs and higher levels of quality. Customers are especially keen on improved consistency and continuous improvement in manufacturing processes, thereby maintaining and improving product quality and cost reduction.

The number-one driver, of course, is cost.

OEMs want more for less. They continue to request year-over-year price reductions, yet also expect near-perfect quality, ever-tightened tolerances and cosmetics, ever-smaller features, on-demand inventory stocking programs, and even extended payment terms.

“Being a contract manufacturer in this demanding and competitive environment is not for the faint of heart,” stated Bellucci.

To meet all these expectations, more contract manufacturers (CMs) are relying on laser processing (cutting, drilling, welding, and etching) to produce smaller parts with complex features, from a wide range of materials, including polymers, metals, glass, and ceramic.

“We’re seeing requests for machined parts smaller than 1 mm [0.039 inches] in overall dimensions, with tolerances of less than 0.0005 inches, holes less than 0.005 inches in diameter, and wall thicknesses less than 0.003 inches,” Bellucci added. “We are constantly pushing the envelope on small parts.”

Fiber and ultrafast lasers are replacing more conventional machining processes because they provide faster throughput and better cut qualities. Lasers can produce features up to an order of magnitude smaller than Swiss computer numerical control (CNC) machines. They can also process parts at low temperatures, without creating heat-affected zones (HAZ) that require secondary processes to fix (particularly important for neurovascular and peripheral vascular products). Two or more lasers can also be combined into a single hybrid laser—for example, fiber and CO2 lasers, or ultraviolet and infrared lasers, can be bundled into one machine for cost-effective processing and part handling.

The second big driver is speed.

In the medical device market, especially with regulatory burdens and cost oversights, speed is everything: speed of design, speed to prototype, speed to market—another advantage lasers typically have over other machining methods.

“Lasers are a single step, scalable process that is material agnostic, enabling life science engineers to go quickly from design to a validated production process,” said Kevin Hartke, chief technology officer for Resonetics in Dayton, Ohio.

Advanced laser capabilities include zero kerf glass cutting. In the personal genomics field (for example, liquid biopsy), a strong need exists for glass-based consumables for sample preparation, data collection, and DNA sequencing. Glass via hole drilling and debris-free, high-speed glass cutting are two important manufacturing processes used for microfluidic chip and interposer fabrication. “Zero kerf cutting with ultrafast lasers cuts glass parts an order of magnitude faster than conventional methods without generating debris, which is critical for certain applications that have sensitive chemistries or micro-channels,” said Ogura.

Femtosecond lasers are preferred for micro drilling and cutting high-precision holes and shapes without any thermal damage. These ultra-fast laser systems essentially vaporize matter without creating a HAZ at the cutting site. This is especially beneficial for complex products/applications such as neurovascular clot pullers, flow diverters, transcatheter structural heart valves repair, and bioresorbable scaffolds. These products require athermal laser technology because “their geometries are small, the material cannot allow any heat during machining, and little or no electro-polishing is required during the manufacturing process,” said Brian Hrouda, director of global sales and marketing for Norman Noble Inc., a Highland Heights, Ohio-based laser contract manufacturer specializing in nitinol-based implants and devices. “Laser machining with ultrashort pulse lasers, such as pico, femto, and our STEALTH laser systems, eliminates the need for costly finishing operations to remove HAZ, saving time and money.”

Traditional Machining Still Strong
Traditional machining methods continue to evolve and stay competitive, especially for certain products and applications. Improvements include smaller cutting tools for CNC machining (which enable the extension of existing CNC machine tools into micro machining). There is keen interest in “hybrid” machine tools, which combine the capabilities of laser cutting and conventional CNC machining into a single system. For example, lasers can be fully integrated with a six-axis precision CNC lathe, with a fully enabled laser-cutting module that operators can use when needed. Even additive manufacturing can be integrated into a single machine tool platform.

Pulse Systems recently purchased a hybrid system—the Tsugami Model SS207-5AX Swiss screw machine with an integral 250W fiber laser. This system enables the production of laser-cut parts with machined features in a single set-up, increasing productivity and eliminating the need to mechanically align features added on one machine to parts made on another machine.

“The most impressive aspect of this machine is the complete integration of its laser cutting and machining capabilities, fully indexed in all 11 axes of motions,” said Bellucci. “In certain situations, this machine represents a game-changing technology because it makes previously impossible designs possible.” Regarding productivity, the payback comes with the full automation of production parts, elimination of duplicate set-ups and smoother part handling and alignment. “Cost savings over current methods of 50 percent or more, as measured in productivity or throughput, are certainly possible in production, depending on the part,” he added.

Wire EDM technology and sinker EDM technology continue to improve every year. Wire EDM is getting faster and more precise, with combinations of improved power supplies and computer monitored/controlled cutting conditions. Wire EDM surface finishes have improved with the addition of non-contact cylindrical drive technology; new software also eliminates the need for lead screws and ball screws. Surface finish can be enhanced with improved anti-electrolysis power supplies, fine finish circuitry, and intelligent internal communication. Speed and throughput are optimized by using more intelligent adaptive control, better-coated wires, and more intelligent systems for unattended machining.

Orthopedic and cardiovascular surgical devices, which increasingly require tighter tolerances and finer finishes, are a good fit for EDM. Wire EDM machines are capable of cutting high-precision stainless steel and titanium medical instruments with small-diameter wires for intricate details and smooth surface finishes. “This is especially important for instruments used in knee surgeries such as orthopedic resection and chamfering guide blocks,” said Bob Tarantino, president of New Jersey Precision Technologies Inc., a Mountainside, N.J.-based EDM contract manufacturer for the medical device industry.

EDM also works well for smaller-order batch sizes with fast turnaround times. Many orthopedic companies are developing new instruments and products that are more tailored to individual body types—so, instead of the one-size-fits-all approach, more styles and sizes of instruments are being designed for body types that are more common to specific parts of the world. This product line diversity requires more types of products in smaller batch sizes.

“The advantages of wire EDM in the production of these smaller batches is that we can make these changes very quickly by only altering a CNC program,” said Tarantino. “Usually no special fixtures are required to make these variations, due to the wide range of flexibility of today’s EDM machines.”

For example, angles as large as 45 degrees can be wire cut by tilting the wire using four-axis programming. Software packages such as DP Technology’s Esprit make the programming task easier for many wire EDM machines. Post processors developed in-house also help automate many programming tasks. Since no special fixtures are required to hold or tilt the instruments, the amount of time to complete the project is greatly reduced. “This fast turnaround is especially important for new product development, especially for testing and validation,” said Tarantino. “Many new designs can be developed quickly and inexpensively with only wire EDM program changes, with no fixtures needed.”

Other Applications
Laser processing can also be combined with other manufacturing technologies (e.g., micro CNC, bonding, 3D printing, etc.) in order to solve the most complex manufacturing challenges, such as low-cost microfluidic devices and diagnostic products. “This streamlines the development process and enables our customers to design and develop products that previously were not able to be fabricated,” said Adelstein.

A good example, he noted, is a microfluidic device/lab-on-a-chip that Potomac Photonics is developing for a customer for early screening of cancer cells. The multi-layer device has 3D features that are fabricated utilizing a micro CNC system, smaller features and holes that require laser processing and, finally, alignment and bonding of the parts that use custom technologies Potomac Photonics has developed. “The bottom line,” said Adelstein, “is that we were able to streamline the build process by combining different technologies, thus greatly reducing build time and overall cost for the prototyping stage.”

Another key aspect of laser processing, especially for implants, disposables, and medical devices, is product marking. Laser marking, laser engraving, and laser micro machining are “outperforming all other product marking technologies, due to their versatilities and adaptability to a wide variety of applications,” said Hadi Lalani, vice president for Applied Manufacturing Technologies Inc., an Anaheim, Calif.-based provider of laser marking, engraving, and micro machining for the medical device industry.

Pretreatment for printing for permanent ink adhesion on medical devices can increase dyne level by up to 75 percent, creating a stronger bond to the substrate and making the adhesion permanent (not removable when it comes in contact with solvents or due to abrasion). “This works especially well with substrates like polyethylene and polypropene,” said Lalani.

Another welcome advancement is high-speed marking, which allows a part to be marked while it is still moving (also known as “marking on the fly”). “For example, extruded tube and wire can be marked by a laser up to a speed of 800 feet/minute,” said Lalani. “Previously, this was only possible with inkjet, and now laser is replacing solvent-based inkjet with this environmental friendly and cost effective process.”

With smaller sizes, more complexity, and tighter tolerances, top-level monitoring and inspection systems are also required to maintain quality. Applied Manufacturing Technologies relies on a smart machine with in-line inspection using an automated vision system to check marking. This can provide 100 percent quality monitoring and documentation at speeds up to 3,000 parts/minute, depending upon application. “The quality criterion are programmed in the vision system program,” said Lalani. “This could be graphic, artwork, color, text, or numerical data. The machine vision system then looks for the predetermined quality requirements on 100 percent of parts and makes pass/fail decisions in dynamic mode.”

Although it is less glamorous than the product itself, process validation is a critical part of taking any product from feasibility to production. It is essential for quality, repeatability, and speed to market. As processes become more complicated, contract manufacturers continue to work with OEMs to improve process validation. This is especially important for more complex devices built with advanced materials and more intricate designs. Process validation is not a regulatory requirement for all laser micromachining processes; only for those that cannot be fully verified by subsequent inspection (such as welding).

“A validated process supports reduced inspection based on known process performance, whereas higher levels of inspection and/or higher risk are associated with running a non-validated process,” said Hartke. “This is a risk-benefit tradeoff that can lead to larger or smaller production release efforts with or without a full-on validation.”

Advanced Materials
New materials give engineers more options and greater flexibility in designing new devices. These materials include biocompatible polyether ether ketone (PEEK), bioresorbable polymers, advanced polymers, composite materials (metals and polymers combined), and metal alloys such as nitinol. Although these materials create more design options and improve product functionality, they are often more challenging to machine. For example, high-performance alloys, such as nitinol, in medical devices present a host of challenges in shape setting and machining. Nitinol is a super-elastic material that cannot be cold-formed as most metals can.

“Nitinol requires specialized fixtures that hold the part shape during heat treatment,” said Pickerell. “There are challenges with removing the tenacious oxide layer that is necessary for biocompatibility. Nitinol is very difficult to machine conventionally, so lasers are ideal for this material.”

Norman Noble offers rapid development prototyping of nitinol-based implants and devices that provides parts within a few days. This requires dedicated shape-setting and electropolishing systems to support the secondary operations for the laser cut prototypes. “This allows design engineers to design and test concepts faster and commercialize products more quickly into the marketplace,” said Hrouda.

Some OEMs think that EDM is not a suitable process for creating titanium implants or delicate medical instruments because the electrical discharge machining process creates a heat-affected zone. This was a problem in the past with some older equipment, which could also cause an unattractive “bluing” condition.

With today’s new equipment, however, such as Mitsubishi EDM machines, this is no longer a problem. “The new MV and FA series power supplies have ‘cool’ cutting technologies that do not create a measurable heat affected zone,” said Tarantino. “Today, EDM is a preferred method to cut titanium and intricate shapes because it does not introduce any stress into the material or effect the temper in any way. For example, we use wire EDM to cut and shape nitinol spinal system frames for the treatment of spondylolisthesis and degenerative disc disease.”

Moving Forward
New micro-scale manufacturing applications will continue to push technological limits with increased functionality, finer features, and tighter tolerances. Ultrafast laser technology continues to become more economical and robust—for example, drilling single-micron holes or laser welding micro-scale parts with features as small as 25 microns. At some point, achieving these details, at such small scale, becomes part science and part art—finding the ideal combination of materials, technologies, and processes to make a complex design feasible. For example, bioresorbable polymers are all different and require different process parameters, depending on design specifications and end use. CMs will, when needed, build their own propriety equipment to meet a customer’s unique requirements.

Additive manufacturing (AM) will have a huge, disruptive influence on machining in years to come. 3D printing is rapidly evolving in printer size, processing speed, and types of material. Additive material processing continues to grow as a real alternative to heavy material removal by traditional machining. Depending on the material properties required, additive processed components can sometimes be used to replace hard-to-machine parts (material or shape), or even multiple components, in a more complicated device.

Although not widely accepted in the medical device industry, 3D printing is being used today in limited ways—for example, making prototypes or manufacturing tools and fixtures. Pulse Systems has used 3D printing to make low-volume, highly complex shape-setting tools used for nitinol processing. AM technologies give product design teams new ways to create innovative products, and/or use advanced materials (even composites), which cannot be made with standard machining or laser processing. This freedom from conventional machining restraints gives designers more latitude to push the feature size envelope.

Machining advances make product design exciting for OEMs and their manufacturing partners—to brainstorm a new challenge, perhaps a design or concept that has never been attempted before, that has the potential to revolutionize a medical procedure or treatment. Working together, in the design phase, to share vision and knowledge and expertise—is the best way to establish long-term, robust partnerships.

“It’s hard to generalize about what customers think is possible, because they often ask us to do the impossible,” said Bellucci. “We are continuously trying to push the envelope on part size, tolerances, quality, and price to turn an innovative design into reality. What will continue to set leading companies like Pulse Systems apart is our willingness to work with product designers, try new ideas, invest in developing our skills, and not give up—to find that intersection of art and science that results in compelling new products.” 


Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-01-30 12:13:50 [updated_at] => 2017-01-30 12:13:50 [last_updated_author] => 195666 [uploaded_by] => 0 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["238358","240963","243443","240964","246131","235314","245577","238355","28588","236224","238375","243904","243474","241073","235987"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238770 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"ASTM International","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141702 [primary_image_old] => [slider_image_id] => 141702 [banner_image] => 0 [title] => New President of ASTM International Announced [short_title] => [summary] => Katharine Morgan succeeds James A. Thomas, who was in role for 25 years. [slug] => new-president-of-astm-international-announced [body] => Today, Katharine “Kathie” Morgan began serving as president of ASTM International, one of the world’s largest standards development organizations. Morgan will lead a team that supports thousands of members, customers, partners, and other stakeholders worldwide. She succeeds James A. Thomas, who served in the role for 25 years.
 
“I am thrilled and humbled to serve as president of an organization that has played such a foundational role inmeeting societal needs for over a century,” Morgan said today at the organization’s first major meeting of 2017 in Norfolk, Va. “We will build on the legacy of Jim Thomas, attracting even more of the world’s top technical experts to our committees while also serving people and organizations that rely on our standards and services.”
 
Her first presidential message was also released today.
 
Morgan was joined at the event today by Thomas Marsh, CEO of Centrotrade and ASTM International’s 2017 chairman of the board. “Kathie brings proven leadership skills, a deep understanding of the global standards community, a passion for ASTM International’s mission, and much more,” Marsh said. “ASTM International will continue to grow and thrive under her leadership.”
 
Also today, Morgan visited the Virginia Beach Fire Department Training Facility to see demonstrations of emergency response robots and drones. Manufacturers, first responders, and others tested robot capabilities and operator proficiency using 50 test methods, many of which have been developed through ASTM International’s Committee on Homeland Security Applications (E54).
 
Morgan is a 33-year veteran of ASTM International. She served as executive vice president for the past two years. Prior to that, she was vice president of Technical Committee Operations, leading a 50-member team that supports the volunteer work of ASTM International’s 30,000 members worldwide.
 
Morgan is one of the world’s most prominent voices on standardization-related issues. She is a board member of the American National Standards Institute’s Board of Directors, the Council of Engineering and Scientific Executives, the International Consumer Product Health and Safety Organization, the Society for Standards Professionals (SES), the American Society of Association Executives, and a former member of the Standards Council of Canada’s Standards Development Organization Advisory Committee.
 
Morgan holds a bachelor’s degree in chemical engineering from Lafayette College in Easton, Pa., and a master’s degree in business administration from Widener University in Chester, Pa. Follow her on Twitter at @ASTMpres.
 
In the following video, Morgan discusses the importance of standards, ASTM's platforms and services, committees for new and emerging industries, and the role that members worldwide play in continuing the success of ASTM International.
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-01 10:00:00 [updated_at] => 2017-02-01 14:44:10 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["242153","248569","244076","241194","237175","244661","244326","240637","237414","237996","242250","247037","243474","241072"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238641 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141662 [primary_image_old] => [slider_image_id] => 141662 [banner_image] => 0 [title] => Hologic Completes Sale of Blood Screening Business to Grifols [short_title] => [summary] => Strengthens effort to build sustainable growth company, accelerates growth rates, increases financial flexibility. [slug] => hologic-completes-sale-of-blood-screening-business-to-grifols [body] => Hologic Inc. has completed the divestiture of its blood screening business to long-time commercial partner, Grifols for a purchase price of $1.85 billion in cash, the company announced.
 
"Completing the divestiture of our blood screening business will strengthen our efforts to build a sustainable growth company by accelerating top- and bottom-line growth rates, while significantly increasing financial flexibility," said Steve MacMillan, the company's chairman, president, and CEO. "We are immensely proud of the contributions we have made to global blood safety over nearly 20 years, and wish our former employees and partner much continued success in the field."
 
Hologic intends to discuss the financial effects of the transaction Feb. 1, when it releases its quarterly financial results and provides updated financial guidance. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-01 10:59:00 [updated_at] => 2017-02-01 11:09:24 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["236598","242244","236882","239769","236011","239606","238043","239150","244690"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 240293 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Advanced Medical Technology Association","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 142648 [primary_image_old] => [slider_image_id] => 142648 [banner_image] => 0 [title] => AdvaMed Urges Device Tax Repeal [short_title] => [summary] => In statement, association’s president and CEO expands on reasons. [slug] => advamed-urges-device-tax-repeal [body] => The Advanced Medical Technology Association (AdvaMed) issued the following statement from president and CEO Scott Whitaker regarding President Donald Trump's upcoming address before a joint session of Congress.
 
“As the president outlines his plans to spur American job creation, we urge him to do one simple thing that will guarantee the growth of good-paying jobs in the U.S.—urge repeal of the medical device excise tax.”
 
“The medical technology industry is a uniquely American success story, responsible for nearly two million high-tech, high-pay jobs in communities large and small in every state.”
 
“But the industry's potential for continued job creation and its ability to develop the next generation of life-changing advancements for patients is under threat by the continued existence of the medical device excise tax. While the current suspension of the tax is helpful, companies need the certainty of permanent repeal in order to invest long-term in R&D, capital improvements, and hiring.”
 
“The president and Congress need to do the right thing and permanently repeal this onerous tax.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-27 08:26:00 [updated_at] => 2017-02-27 08:32:30 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["243616","239331","247736","236660","243320","246608","235541","247996","243454","235786","242519","237209","239148","240745","238375","236746","238365"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238355 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-01-01 [author_name] => {"name":"Michael Barbella","title":"Managing Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141440 [primary_image_old] => [slider_image_id] => 141440 [banner_image] => 0 [title] => Bridging the Digital Divide [short_title] => [summary] => EMS providers with DFM expertise and service flexibility are best suited to help their medtech partners achieve success. [slug] => bridging-the-digital-divide [body] => Kevin J. Tracey decided to become a neurosurgeon when his mother died. He was 5 years old at the time.

Too young to truly comprehend the loss, Tracey sought solace with his maternal grandfather, then a pediatrics professor at Yale University. He wasn’t looking for kind words from the man, a shoulder to cry on, or even a peck on the cheek.

All he wanted was an explanation.

“I climbed onto his lap and asked what happened,” Tracey recalled to The New York Times in a 2014 interview. “He [grandfather] explained that surgeons tried to take it [brain tumor] out but couldn’t separate the tumor tissue from the normal neurons. I remember saying to him, ‘Somebody should do something about that.’ That was when I decided to be a neurosurgeon. I wanted to solve problems that were insolvable.”

Tracey’s personal vendetta against the unsolvable would eventually define his medical career, beginning with the 1985 death of an infant burn victim at New York Hospital. Accidentally doused with boiling pasta water, the girl died suddenly in Tracey’s arms just a few days before her scheduled discharge, and only 24 hours after her first birthday.

The case haunted Tracey for years. He found himself wrestling with a familiar question from childhood: What happened?

He wanted an explanation. Again.

This time, however, Tracey answered his own question. He suspected sepsis, a condition caused by the human immune system’s overwhelming and life-threatening response to an infection. The illness can lead to tissue damage, organ failure, and ultimately, death.

Confounding Tracey’s theory, though, was the lack of bacteria and/or signs of infection anywhere in the victim’s body upon death.

“The more I looked into the problem, the more I realized that basic science lacked a fundamental understanding of why septic shock occurs,” Tracey, now president of The Feinstein Institute for Medical Research (Manhasset, N.Y.) and professor of molecular medicine and neurosurgery at the Hofstra Northwell School of Medicine, told a TEDMED audience last May. “Thirty years ago, I decided to go into the lab and study that problem and my labs have been pursuing that question ever since. What we found changed the way the world thinks about how the body responds to infection.”

Indeed, Tracey’s research changed the way the medical world thinks about organic infection defenses. Specifically, he discovered an interface between nerves and the immune system, disproving a deep-seated scientific consensus that long regarded communication between the two impossible. The conduit for this interplay is the vagus nerve, which helps control and regulate inflammation. Through a series of experiments, Tracey showed that the human nervous system works similarly to a computer terminal, through which commands can be delivered to stop problems like acute inflammation before it begins, or repair the body after an illness.

Tracey’s efforts to better understand the body’s immunological responses has helped establish the emerging new field of bioelectronics, a promising area of medicine that has proven successful in treating acute and chronic immune system disorders (i.e., rheumatoid arthritis, diabetes, psoriasis, inflammatory bowel disease, multiple sclerosis, heart disease, etc.).

The idea of interrupting the vagus nerve-brain conduit with electrical pulses is not an entirely new concept. Vagus nerve stimulation has been used since 1997 to control epileptic seizures and has also been effective at treating drug-resistant cases of clinical depression. But advancements in immunology—due largely to Tracey’s groundbreaking research—are prompting clinicians to test the technique on other difficult-to-manage diseases.

And the results have been encouraging.

Clinical trial subjects implanted with bioelectronic nerve stimulators in their necks have reported significant improvements in rheumatoid arthritis and Crohn’s disease symptoms. Arthritis sufferers, according to study data, experienced fewer swollen joints and pain, while several Crohn’s disease patients achieved complete remission.

Such notable turnarounds are inspiring quests for additional therapies as well: Purdue University researchers, for instance, are investigating bioelectronic therapies for epilepsy, a brain disorder that costs the U.S. healthcare system $15.5 billion annually. Johns Hopkins University scholars, on the other hand, are studying the ways nerve signals affect obesity, diabetes, and gastrointestinal-motility disorders. “What we’re doing today,” Johns Hopkins Medicine and Neurosciences Professor Jay Pasricha said, “is like the precursor to the Model T.”

Only this Model N has more savvy backers.

Last summer, pharmaceutical giant GSK (GlaxoSmithKline) and Verily Life Sciences LLC (formerly Google Life Sciences) formed a company specially tasked with researching, developing, and commercializing bioelectronic therapies. The two partners will contribute 540 million British pounds ($714 million) over seven years to operate Galvani Bioelectronics, aptly named after the 18th century scientist best known for his experiments animating severed frogs’ legs with jolts of electricity.

GSK considers the joint venture with Verily a natural “next step” in its four-year crusade to establish a firm foothold in bioelectronic medicine. The company has invested roughly 45 million euros ($50 million) since 2012 on bioelectronic technology, including a million-dollar prize in 2013 to encourage research into “electroceuticals.”

GSK first unveiled its bioelectronics ambitions three years ago in the journal Nature, and believes it is ahead of its big pharma rivals in developing medical treatments to use electrical impulses rather than traditional chemicals or proteins. Galvani executives expect the first bioelectronic devices to be ready for government inspection in six years.

“This is an ambitious collaboration, allowing GSK and Verily to combine forces and have a huge impact on an emerging field,” Brian Otis, chief technology officer at Verily, said when the partnership was announced. “Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturized technologies.”

Not to mention electronics manufacturing and design prowess. As electrophysiology and neuroscience yield promising new treatments for age-old diseases, companies like Galvani will need to work closely with electronics manufacturing services (EMS) providers to bring their products to market.

“The medical device industry is at a point of significant change,” noted John Carlson, president of Flex Medical Solutions, a division of Flex Ltd., a global provider of sketch-to-scale design, engineering, manufacturing, supply chain insight, and logistics services to various industries, including medical. “There’s a growing recognition that in order for medtech companies to compete, they’re going to have to be much better at collaboration and partnership in certain areas than they’ve historically had to be. We’ve seen ongoing consolidation in the industry, and as a result, companies’ portfolios have become bigger. Consequently, the number of products they’re having to produce has grown almost exponentially. Therefore, the consolidation, the bigger portfolios, and the products’ naturally long lifecycles have forced companies to look at partnering with EMS suppliers in a very different way than in the past.”

One alternate view is beget by a reassessment of core capabilities. Companies with diverse product portfolios are almost never adept in all markets and/or healthcare technologies in which they operate, and thus must outsource with trusted partners to remain competitive.

Privately held biotech firm Ichor Medical Systems adopted this approach in collaborating with Flex on its TriGrid DNA Delivery System, an electroportation device used to deliver DNA vaccines and treatments for various diseases. TriGrid uses electrical fields to increase DNA drug delivery efficiency up to 1,000-fold as compared to conventional injection. The product is comprised of a small, hand-held device that contains a syringe needle and four recessed electrodes arranged in a diamond shape around the central syringe. The design, according to Ichor, is necessary to encompass the tissue in which the drug is administered.

Ichor turned to Flex to incorporate multiple layers of switches in the device, including mechanical, senseless rotational, and optical for accurate drug dose delivery. Flex also developed a special algorithm to compensate for minor deviations in delivery. 

“There’s a growing awareness across large and small companies that the pathway to success is collaborative development or partnerships,” Carlson said. “The old outsourcing model of ‘I give you the spec and you go make this’—those kinds of relationships don’t work out well on the OEM side or the EMS provider side. The collaborative efforts tend to be the best ones, and we’re seeing increased recognition from large and small companies of the need to partner.”

That need has partly been driven by the advent of digital health and the shift from service- to value-based reimbursement models. Digital health entrepreneurs are approaching medicine largely from a data perspective, crafting personalized solutions based on new ways of gathering, viewing, manipulating, and analyzing patient information. Their strategies are blurring industry lines and inspiring new technologies like wearable health devices and activity trackers that put data into users’ hands.  

Among the flood of wearables saturating the market are two wireless smart patches from Silicon Valley startup VitalConnect—the VitalPatch, a disposable biosensor developed in partnership with Flex, and HealthPatch MD, a reusable cardiac monitor.

Both patches continuously measure heart rate, respiratory rate, heart rate variability, skin temperature, posture, and step count, and they’re powered by zinc-air batteries that can last up to four days before requiring replacement. Both devices also are designed to detect falls.

The patches have been certified and cleared for use in the United States, European Union, Japan, and Canada. They are produced in different adhesive grades based on activity and perspiration levels.

“From a medical standpoint, historically we’ve been partnering [with companies] on the manufacturing end,” Carlson explained. “But more and more, we’re helping customers understand how partnering on the innovation side of things can really help them gain a competitive differentiation in the marketplace and allow them to move much faster than they would otherwise do on their own. Many of our newest engagements have really been on the innovation side of things, where we’ve helped customers move into new technology spaces and bridge the different industries much faster and better than they would have without our help.”

Crossovers can be overwhelming, though. Medtech firms unfamiliar with the consumer space are often dumbfounded at the fast pace of product development and amount of risk-taking associated with new innovations. Medical devices require significant understanding of the target audience and are subject to stringent regulatory scrutiny whereas consumer products are more nimble and can be commercialized in a matter of months.

Such an abbreviated product development timeline can be a major stumbling block for healthcare companies traversing the consumer market. Incorporating wireless connectivity into a medical device requires knowledge of WiFi, Bluetooth, radio-frequency identification, near-field communications, and other connective technologies, as well as IEEE standards for information technology and telecommunications/information exchange.

New York City-based startup AdhereTech Inc., for example, leveraged the wireless communications expertise of full-service design firm Intelligent Product Solutions (IPS) to develop a smart, wireless pill bottle that electronically reminds patients to take their medications and alerts caregivers to missed doses. The company estimates that medication non-adherence costs the United States roughly $100 billion and contributes to 100,000 deaths annually.

AdhereTech’s Smart Pill Bottle is basically a standard drug vial with a cellphone radio and prescription inside that occasionally beeps and lights up to remind its owners to take their medications. The bottle requires no syncing or programming, and its battery can last up to 90 days on a full charge.

AdhereTech executives chose wisely in partnering with IPS on the Smart Pill Bottle, as they tapped into a knowledge base of former Symbol Technologies and Motorola experts with experience in all forms of wireless communications—from low-level languages like Zigbee, Bluetooth, and near field to the longer-range protocols of WiFi, GPS, and wide area radio communications.  

Certainly, electronics design and wireless communication expertise are important ingredients for any EMS outsourcing partnership, but they comprise only a small part of the full recipe for success. Quality, of course, is at the top of every device manufacturer’s list of selection criteria, but it’s also imperative to consider location, product complexity, test procedures, circuit board cleanliness, and cost containment, among other factors.

Geography can easily become a deciding factor, depending on whether companies want to manufacture a product near their headquarters or somewhere within the distribution market. “We are seeing increased interest in regional manufacturing as an outsourcing strategy,” said Curtis Campbell, vice president of West Coast sales for SigmaTron International Inc., a full-service EMS provider based in Elk Grove, Ill. “We have U.S. customers that select a specific U.S. or Mexico facility for its proximity to their engineering team or manufacturing locations. In China, we’ve seen increased interest from medical customers for manufacturing support in China to support sales in China. We’ve added ISO 13485:2008 certification to our Suzhou, PRC facility to support that, and we are expanding our support capabilities in the United States as well.”

Naturally, cost is a major consideration when determining location. Manufacturing a product far from home—on another continent or a different hemisphere, perhaps—is significantly more expensive than local assembly, particularly when problems arise. Long-distance production can also be complicated by conflicting time zones, language barriers, and divergent cultures.

Costs can be reasonably mitigated, though, through design for manufacturability (DFM). Incorporating this proactive technique from the start of the product development process not only helps control expenses, but also improves device reliability and sustainability.

“Medical device OEMs have a good knowledge of electronics but they generally don’t have the capability to make a device manufacturable,” said Dave Busch, vice president of Medical, NEO Technology Solutions, at NEO Tech, a Chatsworth, Calif.-based supplier of electronic product design, engineering, and manufacturing services for the medical, defense/aerospace, and industrial markets. “The OEM’s expertise is in leveraging technology to create a solution to a medical problem. The contract manufacturer’s expertise is in making the solution manufacturable.”

Indeed, contract electronics manufacturers can help their partners ensure that designs are practical to make from a cost or materials standpoint, and that those solutions suit the end user. In addition, a closely integrated team can reduce the risk of a “silo” approach and an overemphasis of any one element, while other design considerations are overlooked.

EMS providers can offer the most value to their partners, however, through component obsolescence management. An inevitable and unavoidable by-product of the digital health revolution, antiquated parts can add cost and complexity to any project. At fault is medtech’s long product development lifecycle, which can hamper companies’ abilities to incorporate the latest hardware/software in finished devices. Upgrades can further complicate the development process, as product changes or modifications typically require regulatory recertification.

Component obsolescence can be managed in various ways, though many EMS providers have chosen to tackle the challenge through component monitoring software programs. Such courseware can help identify the timing of part antiquity as well as inventory levels and source reduction.

“When customers design a product, they put a bill of materials together. We take that BOM and buy all the parts and put everything together. Many times, we’ll get a bill of materials and go out to buy the part only to find out that one of the parts is obsolete or will be obsolete in the next year. That already puts you behind the eight ball,” said Michael Goeringer, president of Elk Grove Village, Ill.-based Arc-Tronics Inc., a designer and manufacturer of custom-printed circuit boards, and electromechanical and cable/harness assembly products. “We have some software tools to help customers in this area. We load up their BOM, it goes out to the Web, and it does a risk analysis. There’s an algorithm built into the software program that calculates when a particular part will become obsolete. The report will say, ‘This part is not recommended for design,’ or ‘This part will be obsolete in two years.’ We can help customers avoid these problems if we get involved with them up front. We’re building MRI machines—they’re expensive pieces of equipment that are going to be around for a long time. You need to be able to support those machines for 20 or 30 years. You can’t sell a machine for seven figures and two years later say, ‘That part went bad and there’s no replacement for it.’ That’s not going to be good for the customer. Obsolescence is a huge factor in the design of a product.”

So is cybersecurity. Earlier this year, the U.S. Food and Drug Administration (FDA) confirmed hacking vulnerabilities in St. Jude Medical Inc.’s pacemakers and implantable heart defibrillators, though regulators insisted the hacking risk never endangered patients.

Nevertheless, the confirmation was unsettling, as it highlighted the growing risk posed by mobile health devices and wireless communication networks. A Brookings Institute report issued last year detailed the disturbing extent of that risk, finding that 23 percent of all data breaches occur in the healthcare industry, and nearly 90 percent of healthcare organizations experienced a data breach between 2013 and 2015, costing the industry $6.2 billion.

In late December (2016), the FDA released cybersecurity recommendations for medical device manufacturers, suggesting that device makers monitor their devices and associated software for bugs, and patch any problems that occur.

“One of the challenges EMS providers face in designing connectivity and intelligence into medical products is to have effective cybersecurity management,” noted Wayne Meng, founder, president, and CEO of Sanbor Medical, a medical device contract manufacture company in Allentown, Pa. “Developing a set of cybersecurity control [measures] should include limiting access to devices through the authentication of users, ensuring the data transfer to and from the device using encryption methods, and implementing features that allow for security compromises to be detected, recognized, logged, timed, and acted upon during normal use.”

***
Kevin Tracey envisions a future without drugs.

In that world, medicine and Mother Nature speak the same language, courtesy of infinitesimal microprocessors that can communicate with and control the body’s nervous system. “A patient gets a device implanted once for disease, and they’re done,” he fancied to the Times. “No prescriptions, no medicines, no injections. That’s the future...”

To achieve that future, though, Tracey will need the support of electronics manufacturing service providers, who hold the key to deciphering the body’s biological brogue. Collaborating with these companies can help turn Tracey’s vision into a reality, as they possess both the expertise and service flexibility to become trusted partners.

“Many companies are expert at understanding the market need, but not experts in manufacturing. We continue to see a desire for medical device manufacturers and many of our other customers to look for service delivery flexibility,” said Adrian Nishimoto, operations manager at Spectrum Assembly Inc., a vertically-integrated contract manufacturing firm in Carlsbad, Calif. “San Diego is a medical product development hub and we see many startup clients who have very specific support needs that don’t always fit the typical electronics contract manufacturing model. There is often a ‘gap’ period where they aren’t doing high enough volume manufacturing to attract larger EMS companies, but the complexity of their needs goes beyond what most job shops can offer. We’ve found our ability to listen to their requirements and then fill the gaps in their documentation and materials strategy, plus optimize their assembly processes addresses that issue well.”  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-01-30 11:11:38 [updated_at] => 2017-01-30 11:11:38 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["246122","244421","240724","245199","240267","243461","241062","245205","239928","243471","239966","236614","28588","236105","235477","237340","239865","238371","238356","238377","236746"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238357 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2017-01-01 [author_name] => {"name":"Mark Crawford","title":"Contributing Writer"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141443 [primary_image_old] => [slider_image_id] => 141443 [banner_image] => 0 [title] => A Laser Focus on Precision [short_title] => [summary] => Machining specialists invest in the accuracy of lasers while taking advantage of improved traditional options. [slug] => a-laser-focus-on-precision [body] => Medical devices are increasingly complex and require tighter tolerances and finer finishes, especially for cardiovascular and orthopedic surgical applications. To manufacture these products, medical device manufacturers (MDMs) are constantly asking their contract manufacturers to push the limits of technology—for example, advanced micromachining methods can now achieve features as small as a single micron (for comparison, the diameter of a human hair is 75 microns).

“The machining/laser process market is growing, spurred by the need for innovative advanced manufacturing technologies to fabricate micro products with complex features,” said Mike Adelstein, president and CEO of Potomac Photonics, a Baltimore, Md.-based contract micro fabricator for the medical device, biotech, and electronics industries. “More end-users are focusing on the design stage and outsourcing the prototyping and production processes to contract manufacturers.”

Demand for larger machining/laser processing is also expanding, with existing product lines growing at a healthy rate and innovative new product development programs continuing to “drive quick-turn prototyping and short-run jobs—for example, new clinical applications of robotic surgery,” said Herb Bellucci, CEO of Pulse Systems Inc., a Concord, Calif.-based contract manufacturer that provides precision metal fabrication to the medical device industry.

Although business is good for machinists and contract manufacturers, they are feeling plenty of pressure from OEMs to increase their capacities and capabilities—not just for traditional processes, such as Swiss machining and electrical discharge machining (EDM), but also advanced micromachining and laser processes. Forward-thinking companies realize it is vital to invest in these technologies so they have the tools and know-how to build the increasingly complicated product designs their customers want. For example, Peridot Corporation, a Pleasanton, Calif.-based medical device contract manufacturer, recently purchased and placed into service more than $1.5 million worth of new equipment in 2016, including three new fiber laser systems, to meet growing demands of its clients.

“We can now achieve laser kerf widths of 25 microns with our new laser cutters,” reported Patrick Pickerell, Peridot’s president.

As medical devices get smaller and carry more complexity and functionality, MDMs are turning toward laser processing, especially for technically challenging applications that fall outside the capability boundary of traditional mechanical processes. As a result, laser processing is becoming one of the fast-growing markets in the micro manufacturing sector. Resonetics, for example, a Nashua, N.H.-based provider of laser micro manufacturing services for the medical device industry, reports a sustained double-digit growth in laser micro manufacturing as OEMs continue to globally outsource manufacturing and focus their attention on their core competencies.

The trend of consolidation also continues as mid-size players are purchased by larger organizations. “This consolidation is leaving behind a vacuum of laser core competencies, because strategic acquisitions have diluted capabilities,” said Glenn Ogura, senior vice president of market development for Resonetics.

Laser Processes Reduce Cost
OEMs seek continuity, consistency, and speed when transitioning a project from prototyping to production. Not only do they want faster turns for prototyping and faster production speeds, they want lower costs and higher levels of quality. Customers are especially keen on improved consistency and continuous improvement in manufacturing processes, thereby maintaining and improving product quality and cost reduction.

The number-one driver, of course, is cost.

OEMs want more for less. They continue to request year-over-year price reductions, yet also expect near-perfect quality, ever-tightened tolerances and cosmetics, ever-smaller features, on-demand inventory stocking programs, and even extended payment terms.

“Being a contract manufacturer in this demanding and competitive environment is not for the faint of heart,” stated Bellucci.

To meet all these expectations, more contract manufacturers (CMs) are relying on laser processing (cutting, drilling, welding, and etching) to produce smaller parts with complex features, from a wide range of materials, including polymers, metals, glass, and ceramic.

“We’re seeing requests for machined parts smaller than 1 mm [0.039 inches] in overall dimensions, with tolerances of less than 0.0005 inches, holes less than 0.005 inches in diameter, and wall thicknesses less than 0.003 inches,” Bellucci added. “We are constantly pushing the envelope on small parts.”

Fiber and ultrafast lasers are replacing more conventional machining processes because they provide faster throughput and better cut qualities. Lasers can produce features up to an order of magnitude smaller than Swiss computer numerical control (CNC) machines. They can also process parts at low temperatures, without creating heat-affected zones (HAZ) that require secondary processes to fix (particularly important for neurovascular and peripheral vascular products). Two or more lasers can also be combined into a single hybrid laser—for example, fiber and CO2 lasers, or ultraviolet and infrared lasers, can be bundled into one machine for cost-effective processing and part handling.

The second big driver is speed.

In the medical device market, especially with regulatory burdens and cost oversights, speed is everything: speed of design, speed to prototype, speed to market—another advantage lasers typically have over other machining methods.

“Lasers are a single step, scalable process that is material agnostic, enabling life science engineers to go quickly from design to a validated production process,” said Kevin Hartke, chief technology officer for Resonetics in Dayton, Ohio.

Advanced laser capabilities include zero kerf glass cutting. In the personal genomics field (for example, liquid biopsy), a strong need exists for glass-based consumables for sample preparation, data collection, and DNA sequencing. Glass via hole drilling and debris-free, high-speed glass cutting are two important manufacturing processes used for microfluidic chip and interposer fabrication. “Zero kerf cutting with ultrafast lasers cuts glass parts an order of magnitude faster than conventional methods without generating debris, which is critical for certain applications that have sensitive chemistries or micro-channels,” said Ogura.

Femtosecond lasers are preferred for micro drilling and cutting high-precision holes and shapes without any thermal damage. These ultra-fast laser systems essentially vaporize matter without creating a HAZ at the cutting site. This is especially beneficial for complex products/applications such as neurovascular clot pullers, flow diverters, transcatheter structural heart valves repair, and bioresorbable scaffolds. These products require athermal laser technology because “their geometries are small, the material cannot allow any heat during machining, and little or no electro-polishing is required during the manufacturing process,” said Brian Hrouda, director of global sales and marketing for Norman Noble Inc., a Highland Heights, Ohio-based laser contract manufacturer specializing in nitinol-based implants and devices. “Laser machining with ultrashort pulse lasers, such as pico, femto, and our STEALTH laser systems, eliminates the need for costly finishing operations to remove HAZ, saving time and money.”

Traditional Machining Still Strong
Traditional machining methods continue to evolve and stay competitive, especially for certain products and applications. Improvements include smaller cutting tools for CNC machining (which enable the extension of existing CNC machine tools into micro machining). There is keen interest in “hybrid” machine tools, which combine the capabilities of laser cutting and conventional CNC machining into a single system. For example, lasers can be fully integrated with a six-axis precision CNC lathe, with a fully enabled laser-cutting module that operators can use when needed. Even additive manufacturing can be integrated into a single machine tool platform.

Pulse Systems recently purchased a hybrid system—the Tsugami Model SS207-5AX Swiss screw machine with an integral 250W fiber laser. This system enables the production of laser-cut parts with machined features in a single set-up, increasing productivity and eliminating the need to mechanically align features added on one machine to parts made on another machine.

“The most impressive aspect of this machine is the complete integration of its laser cutting and machining capabilities, fully indexed in all 11 axes of motions,” said Bellucci. “In certain situations, this machine represents a game-changing technology because it makes previously impossible designs possible.” Regarding productivity, the payback comes with the full automation of production parts, elimination of duplicate set-ups and smoother part handling and alignment. “Cost savings over current methods of 50 percent or more, as measured in productivity or throughput, are certainly possible in production, depending on the part,” he added.

Wire EDM technology and sinker EDM technology continue to improve every year. Wire EDM is getting faster and more precise, with combinations of improved power supplies and computer monitored/controlled cutting conditions. Wire EDM surface finishes have improved with the addition of non-contact cylindrical drive technology; new software also eliminates the need for lead screws and ball screws. Surface finish can be enhanced with improved anti-electrolysis power supplies, fine finish circuitry, and intelligent internal communication. Speed and throughput are optimized by using more intelligent adaptive control, better-coated wires, and more intelligent systems for unattended machining.

Orthopedic and cardiovascular surgical devices, which increasingly require tighter tolerances and finer finishes, are a good fit for EDM. Wire EDM machines are capable of cutting high-precision stainless steel and titanium medical instruments with small-diameter wires for intricate details and smooth surface finishes. “This is especially important for instruments used in knee surgeries such as orthopedic resection and chamfering guide blocks,” said Bob Tarantino, president of New Jersey Precision Technologies Inc., a Mountainside, N.J.-based EDM contract manufacturer for the medical device industry.

EDM also works well for smaller-order batch sizes with fast turnaround times. Many orthopedic companies are developing new instruments and products that are more tailored to individual body types—so, instead of the one-size-fits-all approach, more styles and sizes of instruments are being designed for body types that are more common to specific parts of the world. This product line diversity requires more types of products in smaller batch sizes.

“The advantages of wire EDM in the production of these smaller batches is that we can make these changes very quickly by only altering a CNC program,” said Tarantino. “Usually no special fixtures are required to make these variations, due to the wide range of flexibility of today’s EDM machines.”

For example, angles as large as 45 degrees can be wire cut by tilting the wire using four-axis programming. Software packages such as DP Technology’s Esprit make the programming task easier for many wire EDM machines. Post processors developed in-house also help automate many programming tasks. Since no special fixtures are required to hold or tilt the instruments, the amount of time to complete the project is greatly reduced. “This fast turnaround is especially important for new product development, especially for testing and validation,” said Tarantino. “Many new designs can be developed quickly and inexpensively with only wire EDM program changes, with no fixtures needed.”

Other Applications
Laser processing can also be combined with other manufacturing technologies (e.g., micro CNC, bonding, 3D printing, etc.) in order to solve the most complex manufacturing challenges, such as low-cost microfluidic devices and diagnostic products. “This streamlines the development process and enables our customers to design and develop products that previously were not able to be fabricated,” said Adelstein.

A good example, he noted, is a microfluidic device/lab-on-a-chip that Potomac Photonics is developing for a customer for early screening of cancer cells. The multi-layer device has 3D features that are fabricated utilizing a micro CNC system, smaller features and holes that require laser processing and, finally, alignment and bonding of the parts that use custom technologies Potomac Photonics has developed. “The bottom line,” said Adelstein, “is that we were able to streamline the build process by combining different technologies, thus greatly reducing build time and overall cost for the prototyping stage.”

Another key aspect of laser processing, especially for implants, disposables, and medical devices, is product marking. Laser marking, laser engraving, and laser micro machining are “outperforming all other product marking technologies, due to their versatilities and adaptability to a wide variety of applications,” said Hadi Lalani, vice president for Applied Manufacturing Technologies Inc., an Anaheim, Calif.-based provider of laser marking, engraving, and micro machining for the medical device industry.

Pretreatment for printing for permanent ink adhesion on medical devices can increase dyne level by up to 75 percent, creating a stronger bond to the substrate and making the adhesion permanent (not removable when it comes in contact with solvents or due to abrasion). “This works especially well with substrates like polyethylene and polypropene,” said Lalani.

Another welcome advancement is high-speed marking, which allows a part to be marked while it is still moving (also known as “marking on the fly”). “For example, extruded tube and wire can be marked by a laser up to a speed of 800 feet/minute,” said Lalani. “Previously, this was only possible with inkjet, and now laser is replacing solvent-based inkjet with this environmental friendly and cost effective process.”

With smaller sizes, more complexity, and tighter tolerances, top-level monitoring and inspection systems are also required to maintain quality. Applied Manufacturing Technologies relies on a smart machine with in-line inspection using an automated vision system to check marking. This can provide 100 percent quality monitoring and documentation at speeds up to 3,000 parts/minute, depending upon application. “The quality criterion are programmed in the vision system program,” said Lalani. “This could be graphic, artwork, color, text, or numerical data. The machine vision system then looks for the predetermined quality requirements on 100 percent of parts and makes pass/fail decisions in dynamic mode.”

Although it is less glamorous than the product itself, process validation is a critical part of taking any product from feasibility to production. It is essential for quality, repeatability, and speed to market. As processes become more complicated, contract manufacturers continue to work with OEMs to improve process validation. This is especially important for more complex devices built with advanced materials and more intricate designs. Process validation is not a regulatory requirement for all laser micromachining processes; only for those that cannot be fully verified by subsequent inspection (such as welding).

“A validated process supports reduced inspection based on known process performance, whereas higher levels of inspection and/or higher risk are associated with running a non-validated process,” said Hartke. “This is a risk-benefit tradeoff that can lead to larger or smaller production release efforts with or without a full-on validation.”

Advanced Materials
New materials give engineers more options and greater flexibility in designing new devices. These materials include biocompatible polyether ether ketone (PEEK), bioresorbable polymers, advanced polymers, composite materials (metals and polymers combined), and metal alloys such as nitinol. Although these materials create more design options and improve product functionality, they are often more challenging to machine. For example, high-performance alloys, such as nitinol, in medical devices present a host of challenges in shape setting and machining. Nitinol is a super-elastic material that cannot be cold-formed as most metals can.

“Nitinol requires specialized fixtures that hold the part shape during heat treatment,” said Pickerell. “There are challenges with removing the tenacious oxide layer that is necessary for biocompatibility. Nitinol is very difficult to machine conventionally, so lasers are ideal for this material.”

Norman Noble offers rapid development prototyping of nitinol-based implants and devices that provides parts within a few days. This requires dedicated shape-setting and electropolishing systems to support the secondary operations for the laser cut prototypes. “This allows design engineers to design and test concepts faster and commercialize products more quickly into the marketplace,” said Hrouda.

Some OEMs think that EDM is not a suitable process for creating titanium implants or delicate medical instruments because the electrical discharge machining process creates a heat-affected zone. This was a problem in the past with some older equipment, which could also cause an unattractive “bluing” condition.

With today’s new equipment, however, such as Mitsubishi EDM machines, this is no longer a problem. “The new MV and FA series power supplies have ‘cool’ cutting technologies that do not create a measurable heat affected zone,” said Tarantino. “Today, EDM is a preferred method to cut titanium and intricate shapes because it does not introduce any stress into the material or effect the temper in any way. For example, we use wire EDM to cut and shape nitinol spinal system frames for the treatment of spondylolisthesis and degenerative disc disease.”

Moving Forward
New micro-scale manufacturing applications will continue to push technological limits with increased functionality, finer features, and tighter tolerances. Ultrafast laser technology continues to become more economical and robust—for example, drilling single-micron holes or laser welding micro-scale parts with features as small as 25 microns. At some point, achieving these details, at such small scale, becomes part science and part art—finding the ideal combination of materials, technologies, and processes to make a complex design feasible. For example, bioresorbable polymers are all different and require different process parameters, depending on design specifications and end use. CMs will, when needed, build their own propriety equipment to meet a customer’s unique requirements.

Additive manufacturing (AM) will have a huge, disruptive influence on machining in years to come. 3D printing is rapidly evolving in printer size, processing speed, and types of material. Additive material processing continues to grow as a real alternative to heavy material removal by traditional machining. Depending on the material properties required, additive processed components can sometimes be used to replace hard-to-machine parts (material or shape), or even multiple components, in a more complicated device.

Although not widely accepted in the medical device industry, 3D printing is being used today in limited ways—for example, making prototypes or manufacturing tools and fixtures. Pulse Systems has used 3D printing to make low-volume, highly complex shape-setting tools used for nitinol processing. AM technologies give product design teams new ways to create innovative products, and/or use advanced materials (even composites), which cannot be made with standard machining or laser processing. This freedom from conventional machining restraints gives designers more latitude to push the feature size envelope.

Machining advances make product design exciting for OEMs and their manufacturing partners—to brainstorm a new challenge, perhaps a design or concept that has never been attempted before, that has the potential to revolutionize a medical procedure or treatment. Working together, in the design phase, to share vision and knowledge and expertise—is the best way to establish long-term, robust partnerships.

“It’s hard to generalize about what customers think is possible, because they often ask us to do the impossible,” said Bellucci. “We are continuously trying to push the envelope on part size, tolerances, quality, and price to turn an innovative design into reality. What will continue to set leading companies like Pulse Systems apart is our willingness to work with product designers, try new ideas, invest in developing our skills, and not give up—to find that intersection of art and science that results in compelling new products.” 


Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-01-30 12:13:50 [updated_at] => 2017-01-30 12:13:50 [last_updated_author] => 195666 [uploaded_by] => 0 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["238358","240963","243443","240964","246131","235314","245577","238355","28588","236224","238375","243904","243474","241073","235987"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238770 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"ASTM International","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141702 [primary_image_old] => [slider_image_id] => 141702 [banner_image] => 0 [title] => New President of ASTM International Announced [short_title] => [summary] => Katharine Morgan succeeds James A. Thomas, who was in role for 25 years. [slug] => new-president-of-astm-international-announced [body] => Today, Katharine “Kathie” Morgan began serving as president of ASTM International, one of the world’s largest standards development organizations. Morgan will lead a team that supports thousands of members, customers, partners, and other stakeholders worldwide. She succeeds James A. Thomas, who served in the role for 25 years.
 
“I am thrilled and humbled to serve as president of an organization that has played such a foundational role inmeeting societal needs for over a century,” Morgan said today at the organization’s first major meeting of 2017 in Norfolk, Va. “We will build on the legacy of Jim Thomas, attracting even more of the world’s top technical experts to our committees while also serving people and organizations that rely on our standards and services.”
 
Her first presidential message was also released today.
 
Morgan was joined at the event today by Thomas Marsh, CEO of Centrotrade and ASTM International’s 2017 chairman of the board. “Kathie brings proven leadership skills, a deep understanding of the global standards community, a passion for ASTM International’s mission, and much more,” Marsh said. “ASTM International will continue to grow and thrive under her leadership.”
 
Also today, Morgan visited the Virginia Beach Fire Department Training Facility to see demonstrations of emergency response robots and drones. Manufacturers, first responders, and others tested robot capabilities and operator proficiency using 50 test methods, many of which have been developed through ASTM International’s Committee on Homeland Security Applications (E54).
 
Morgan is a 33-year veteran of ASTM International. She served as executive vice president for the past two years. Prior to that, she was vice president of Technical Committee Operations, leading a 50-member team that supports the volunteer work of ASTM International’s 30,000 members worldwide.
 
Morgan is one of the world’s most prominent voices on standardization-related issues. She is a board member of the American National Standards Institute’s Board of Directors, the Council of Engineering and Scientific Executives, the International Consumer Product Health and Safety Organization, the Society for Standards Professionals (SES), the American Society of Association Executives, and a former member of the Standards Council of Canada’s Standards Development Organization Advisory Committee.
 
Morgan holds a bachelor’s degree in chemical engineering from Lafayette College in Easton, Pa., and a master’s degree in business administration from Widener University in Chester, Pa. Follow her on Twitter at @ASTMpres.
 
In the following video, Morgan discusses the importance of standards, ASTM's platforms and services, committees for new and emerging industries, and the role that members worldwide play in continuing the success of ASTM International.
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-01 10:00:00 [updated_at] => 2017-02-01 14:44:10 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["242153","248569","244076","241194","237175","244661","244326","240637","237414","237996","242250","247037","243474","241072"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 238641 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 141662 [primary_image_old] => [slider_image_id] => 141662 [banner_image] => 0 [title] => Hologic Completes Sale of Blood Screening Business to Grifols [short_title] => [summary] => Strengthens effort to build sustainable growth company, accelerates growth rates, increases financial flexibility. [slug] => hologic-completes-sale-of-blood-screening-business-to-grifols [body] => Hologic Inc. has completed the divestiture of its blood screening business to long-time commercial partner, Grifols for a purchase price of $1.85 billion in cash, the company announced.
 
"Completing the divestiture of our blood screening business will strengthen our efforts to build a sustainable growth company by accelerating top- and bottom-line growth rates, while significantly increasing financial flexibility," said Steve MacMillan, the company's chairman, president, and CEO. "We are immensely proud of the contributions we have made to global blood safety over nearly 20 years, and wish our former employees and partner much continued success in the field."
 
Hologic intends to discuss the financial effects of the transaction Feb. 1, when it releases its quarterly financial results and provides updated financial guidance. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-01 10:59:00 [updated_at] => 2017-02-01 11:09:24 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["236598","242244","236882","239769","236011","239606","238043","239150","244690"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 240293 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Advanced Medical Technology Association","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 142648 [primary_image_old] => [slider_image_id] => 142648 [banner_image] => 0 [title] => AdvaMed Urges Device Tax Repeal [short_title] => [summary] => In statement, association’s president and CEO expands on reasons. [slug] => advamed-urges-device-tax-repeal [body] => The Advanced Medical Technology Association (AdvaMed) issued the following statement from president and CEO Scott Whitaker regarding President Donald Trump's upcoming address before a joint session of Congress.
 
“As the president outlines his plans to spur American job creation, we urge him to do one simple thing that will guarantee the growth of good-paying jobs in the U.S.—urge repeal of the medical device excise tax.”
 
“The medical technology industry is a uniquely American success story, responsible for nearly two million high-tech, high-pay jobs in communities large and small in every state.”
 
“But the industry's potential for continued job creation and its ability to develop the next generation of life-changing advancements for patients is under threat by the continued existence of the medical device excise tax. While the current suspension of the tax is helpful, companies need the certainty of permanent repeal in order to invest long-term in R&D, capital improvements, and hiring.”
 
“The president and Congress need to do the right thing and permanently repeal this onerous tax.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-02-27 08:26:00 [updated_at] => 2017-02-27 08:32:30 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["243616","239331","247736","236660","243320","246608","235541","247996","243454","235786","242519","237209","239148","240745","238375","236746","238365"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedSearches] => Array ( [0] => Taxonomy Object ( [className] => Taxonomy [id] => 61512 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => taxonomy [taxonomy_tag] => 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