1. AutoForm was founded in 1995 and is recognized as the leading supplier of software solutions for die-making and sheet-metal-forming industries.
Since then, the company has continually grown at a rapid pace. The company has profoundly revolutionized the market with its innovations for swift and reliable validation of the design, engineering, and manufacturing processes. AutoForm is well known in the forming simulation industry for its fast-solving speed and ease of use.
2. Simulate the forming process using AutoForm.
AutoForm simulation is a crucial tool for engineering small parts and their manufacturing processes. AutoForm’s technology generates simulation results that accurately predict all aspects of physical component quality, as well as dimensional compliance. By analyzing potential issues in the virtual world using simulation, it’s possible to avoid costly issues in real-world tooling.
3. AutoForm can predict forming issues such as splitting, thinning, wrinkling, and spring-back, and the software provides analysis of part variation.
This allows companies to make countermeasures to resolve issues prior to tooling while adhering to the tight design tolerances required in the medical industry. By using AutoForm simulation, companies can shorten their overall engineering and tooling timelines.
Pacemaker shell: Plot showing areas where there is high thinning (red) and thickening (purple).
4. AutoForm simulation technology can be used on exotic materials.
Companies rely on AutoForm’s Material Generator to depict exotic material behavior during the forming process. Material characteristics collected from easily performed tests and incorporated into AutoForm’s Material Generator can greatly increase the accuracy of simulation results. Materials include stainless steel, titanium, Nitinol, Inconel, and others commonly used in the medical industry.
Pacemaker shell : Spring-back plot showing displacement from the reference part in the normal direction.5. Based on spring-back results, tool geometry can be compensated within AutoForm.
Using AutoForm’s Compensator module, die faces are compensated in the opposite direction of spring-back. Final part geometry within the required tolerances is achieved with a minimum amount of correction loops. The biggest advantage with AutoForm’s Compensator module is the advanced engineering methods which are used to reduce or eliminate costly recuts to the forming dies.
The MH 320A horizontal machining center uses a PC2 automatic pallet changer (APC) with 12.6" (320mm) pallets to lower cycle times and increase throughput.
The MH 320A’s work envelope measures 16.9" (430mm) in diameter by 18.7" (457mm) in height and can handle workloads up to 551 lb (250kg).
The BIG-PLUS 40 taper direct-drive spindle ensures tool longevity and optimal part finish. Also included is a Fanuc 0iMF control and 40-tool automatic tool changer (ATC).
Medical device manufacturers must continually increase production speed and efficiency while reducing labor, spurring automation. However, off-the-shelf equipment won’t accommodate every application, particularly complex ones with robots, conveyors, and a host of equipment for manufacture, assembly, packaging, labeling, and palletizing.
In such cases, medical device manufacturers looking to increase the speed and efficiency of production and packaging lines need an automation partner who can quickly and cost-effectively deliver tailored, custom solutions. Ideally, the partner can design, build, and integrate high-speed, high-volume automated equipment and systems.
It is crucial to partner with an expert supplier to overcome specifications challenges, regulatory requirements, system integration, customization, and the need to complete work on time and within budget.
“While implementing off-the-shelf solutions can be a starting point for some projects, automation incorporating robotics frequently require a custom solution that meets very specific process requirements,” says Leon Gurevich, founder and chief technology officer of Rapid Development Services (RDS), an industrial automation equipment builder providing design, engineering, integration, and fabrication of production machinery. “Even large suppliers in this space will often pass on opportunities if they aren’t easily resolved.”
To avoid delays or failure on larger, more complex projects, Gurevich says it’s particularly important to work with a nimble, flexible supplier with the appropriate expertise. RDS has implemented more than 300 complex projects worldwide and holds more than 40 patents.
“When it comes to automating production, equipment can range from very small to complete lines several hundred feet long that can consist of robots, conveyors, vision systems, server drives, etc.,” Gurevich says. He has worked with Medtronic, Johnson & Johnson, Abbott Labs, and Pfizer and adds that “automation suppliers and integrators need a toolbox full of solutions, including the ability to design and build from scratch to fit together all the pieces of the puzzle.”
RDS typically uses standardized off-the-shelf solutions and integrates them with other systems, but it can design and manufacture equipment and sub-systems from scratch.
This includes automated assembly solutions, inspection systems, packaging equipment, labeling/marking systems, and palletizing automation, as well as filling systems and machine-tending automation.
For example, after a major medical device manufacturer received U.S. Food and Drug Administration (FDA) approval of a real-time insulin pump for continuous glucose monitoring (CGM), RDS was called on to develop a system to package insulin reservoir-syringes into a Multivac Form Fill Seal machine, followed by carton and case packing for ready-to-ship product delivery.
The reservoir-syringe presents to the system in bulk form. The robotic system uses vision inspection to check for the presence of subcomponents before placing reservoir-syringes into the Multivac machine’s cavities. Vision inspection identifies the presence of the plunger, guard, and overall syringe geometry pattern by inspecting a set of 10 units per cycle. The system uses two 6-axis robots, two Vibro-feed bowls, and the Multivac web machine to feed, pick, place, and seal reservoir syringes.
Two cells package more than 120 reservoirs per minute, for a total of 240 units per minute. The packaging system also has a carton erector, and inserts the sealed packages into cartons.
Advantages can be gained when working with an integrator that can couple the knowledge of custom machine building with standardized robotics as well as developing specific control and communication support between production machinery and operator or inventory management systems.
PHOTO: RAPID DEVELOPMENT SERVICES
Off-the-shelf equipment won’t accommodate every automation application, particularly complex ones.
PHOTO: RAPID DEVELOPMENT SERVICES
RDS initially installed the system in a California plant, which ran the robotic system trouble-free in a cleanroom for more than 5 years. At the company’s request, RDS disassembled, moved, reinstalled, and restarted the system at a new facility in Puerto Rico, where it’s run trouble-free, three shifts per day, for 10 years.
Whether medical device manufacturers need help to automate production or equipment used in provider settings, partnering with an expert in automation can be the surest route to ensuring compliance, reliability, and efficiency.
“Companies sometimes shy away from automation when only focusing on direct labor savings or short-term return on investment (ROI),” RDS President Sunit Mishra says. “However, if you factor in increased production speeds and improved quality along with reduced waste, labor management savings, labor hiring and training savings, as well as repetitive motion injury, the investment in automation usually provides an attractive ROI in the short term itself… not to mention, our history shows equipment life spans of well over 20 years, where the ongoing benefits continue to accrue to the bottom line for the life of the equipment.”
Patent assertion entities (PAEs), more colloquially referred to as patent trolls, focus their attention primarily on high-tech and software companies. By one estimate, PAEs have been responsible for more than 84% of U.S. high-tech patent litigation.[1]
As medical technology and imaging companies become more reliant on technology, they increase their risk of being sued by PAEs. Throughout the last 10 years, several PAEs have aggressively attacked Olympus with threats of patent infringement cases. These lawsuits are a distraction and divert time and money away from innovation-driving activities such as research and product development. Unfortunately, we are seeing an upswing in such activity. Unified Patents reported that in 2019 alone, patent litigation was up 4% across all industries.[2]
Patent assertion entities problem
PAEs are companies that acquire patents to monetize them by suing other companies. In 2013, RPX Corp. reported that only about 2% of medical-based companies were targets of PAEs.[3] By the end of last year, IAM found there was “a big jump in healthcare and pharma transactions with evidence of growing patent activity in the medtech space in particular.”[4] Our industry will likely see more patent transactions that could ultimately lead to more infringement litigation – especially during an economic downturn when distressed companies are looking to offload assets or up their patent monetization plans.
Trolls’ costs
In 2014, Massachusetts Institute of Technology (MIT) management science and marketing professor Catherine Tucker conducted a study showing that a patent troll’s litigation led to a decline of nearly one-third of medical imaging technology sales. Her research showed how product innovation also declined during the period of litigation.
In her study, she found that:
“An explanation for this lack of innovation is that the vendors didn’t want to run the risk of being found guilty of willful infringement in the patent suit and being held liable for treble damages. Therefore, one explanation of the slow-down in sales is that the product release and attendant sales cycle was halted because of litigation. This emphasizes that even if patent assertion entities don’t prevail in the courtroom, their actions can have significantly negative consequences for incremental innovation while litigation is ongoing.”[5]
It’s clear that companies defending against PAEs spend less on innovation and other business strategies, and as Tucker’s study found, product sales can decline rapidly or halt.
Some estimates suggest that patent trolls are associated with more than $80 billion a year in lost wealth for defendants[6] and on average, firms forced to pay patent trolls spend $211 million less on research and development (R&D).[7]
As a company that has been the target of several patent trolls, Olympus is well aware of the high costs associated with litigating, defending, and paying licensing fees – all of which have affected our own efforts to further our life-saving innovations and safeguard the overall health of the company.
These costs can derail most R&D efforts and often can only be recouped by increasing prices, which is unfair to medical customers working hard to stretch resources to best serve their patients.
Defense against infringement
Recently, Olympus decided to immunize ourselves from patent trolls by aligning with other global companies that have the same goal in mind: protect innovation from the threat and high cost of PAE litigation.
Olympus joined LOT Network, a non-profit community of more than 1,000 companies. All agree if, and only if, a member company’s patent falls into the hands of a patent troll, that company will grant the network’s other members a license to that patent. Therefore, the patent can no longer be used by trolls to sue community members, while the usual uses of patents, buying and selling and suing companies who infringe on company IP, are still preserved.
At Olympus, we believe that every penny spent fending off PAEs harms innovation – and the single focus of LOT is to preserve the traditional uses and value of patents – while immunizing companies from the escalating costs associated with PAE litigation.
In addition to the protections afforded through the LOT Network, we are now community members of like-minded companies collectively recognized as global IP thought leaders, including innovators IBM, Toyota, Canon, Tesla, and Microsoft.
LOT Network is a community that grows stronger and becomes more valuable as membership increases. We encourage other medical technology companies to join us in protecting critical IP.
About the author: Gael Tisack, global head of intellectual property (IP) at Olympus, joined the company in 2018 and has a career in this area spanning more than 20 years. She is responsible for the IP strategy and providing IP advice to Olympus affiliates on matters including litigation, licensing, risk mitigation, and mergers and acquisitions. She also has the responsible to ensure that Olympus’s IP portfolio supports the business products and strategies.
Laser systems have been important to the medical device industry since they were first commercialized in the 1970s. As laser technologies have evolved, they have enabled improved medical product designs. There have been several new laser technologies adopted in recent years, including ultra-short-pulsed lasers that impart negligible heat into medical device workpieces. Also, vision systems, such as smart cameras and their software, are now widely integrated into laser systems to verify a perfect product.
Laser materials processing systems produce devices for life-saving cardiac rhythm management, neuromodulation, orthopedics, and hearing implants. While these are more common applications of laser processing systems, the application base is expanding rapidly with new products centered around the availability of laser machine systems.
Cardiology
Pacemakers contain heat-sensitive electronics, which is one reason laser systems are used to manufacture them – net heat transfer is manageable with appropriately engineered laser systems.
Producing cardiac rhythm management devices requires several industrial laser processes. Laser welding with pulsed fiber lasers provides a hermetic seal on the pacemaker cartridge; wire stripping of electrodes is done with q-switched and short pulsed lasers; and fiber laser markers place unique device identification (UDI) codes onto the device.
Lasers also lend themselves to automation, such as their integration into a glovebox welding system to prevent oxidation of welded pacemakers. Before the advent of fiber laser technology in the medical device industry in the mid 2000s, these were manufactured using legacy solid- state, rod-based lasers from the late 1980s.
Neuromodulation
A growing therapy, neuromodulation devices implanted in the brain tissue or spinal cord control the effects of conditions such as Parkinson’s Disease and essential tremor, improving motor coordination. The electrodes are made from relatively inert metals coated with plastics. To reveal the electrodes for subsequent embedding in the body, manufacturers laser wire strip the fluoropolymer jackets – often polytetrafluoroethylene (PTFE) or other polymers such as polyethylene terephthalate (PET) or polyimide – from the delicate wires made from platinum and copper.
Laser systems produce diverse edge qualities and effects on the bare metal, and one advantage is how well they can be integrated into turnkey automated systems for manufacturing. In addition, they don’t touch or impart much mechanical force onto wires that often have 0.001" diameters. Those processes, when done manually under a microscope, required dexterity, were laborious, and could not be automated, which is why today’s manufacturers prefer laser systems.
Orthopedics
An ACSYS laser system cuts a bone saw. Credit: ACSYS Lasertechnik
For many years, manufacturers have laser marked and engraved orthopedic implants with some devices laser welded or laser 3D-printed from metal powders. The complete laser generation of orthopedic implants has led to mass customization using data generated from magnetic resonance imaging (MRI). Laser systems can also polish selective areas of the metal implants to lower the surface roughness from the original 5-axis CNC machined surface. Conversely, laser machining systems can strategically roughen orthopedic implants to provide surfaces for cells to osseointegrate.
Coupling laser-based manufacturing with order-data handling interfaces, forms an integrated laser system that links directly to the product ordering and verification system. This provides traceability and quality checks for each part and logs everything that took place during a laser processing operation, eliminating compliance risk.
Instrumentation used in orthopedic implants also embraces laser processing, from laser cutting bone saws to welding saw cartridges and marking graduated scales for surgical cutting depth.
Cochlear implants
Analogous laser structuring technology used on small cochlear implants can improve hearing. Laser systems can usually be matched to the product’s scale and production volume with a fast return on investment (ROI).
Many other processes aren’t discussed here, such as microfluidic assay device machining, engraving and structuring ceramics and glasses used in medical devices, cutting metals and plastics for stents, hypotubes, surgical blades, and welding plastics.
Future applications
Since their inception, laser systems have contributed greatly to the successful creation of many types of medical devices. For surgical or implanted devices, lasers can ensure that parts are identifiable, non-corrosive, and non-toxic. With their versatility and ability to process a wide range of materials, lasers will offer more cost-effective and innovative processes as medical technologies continue to rapidly advance. Laser technology will benefit design engineers and healthcare professions in bringing state-of-the-art opportunities to mitigate risks, assure regulatory compliance, and elevate patient safety.
About the author: Jonathan Magee is managing director of ACSYS Lasertechnik U.K. Ltd. He has been continuously involved with the application of laser technology in manufacturing since 1995.
Posted by Elizabeth Engler Modic
Posted by Elizabeth Engler Modic
