The U.S. Food and Drug Administration (FDA) is warning about vulnerabilities that may introduce risks for certain medical devices and hospital networks.
The Medical Imaging & Technology Alliance (MITA) published NEMA/MITA HN 1-2019, Manufacturer Disclosure Statement for Medical Device Security (MDS2), a voluntary standard that supports security risk management within healthcare delivery organizations by providing standardized information on security control features integrated within medical devices.
Development of the standard was led by MITA in conjunction with a diverse group of interested parties. It includes a form intended to provide healthcare delivery organizations with crucial information and security control features within medical devices. It also clarifies the roles of manufacturers and healthcare delivery organizations in ensuring secure medical devices.
The shared responsibility recognized by this standard aligns with the position of the U.S. Food and Drug Administration, which released a preparedness and response playbook to help organizations address threats to medical device cybersecurity.
Cybersecurity vulnerabilities
The U.S. Food and Drug Administration (FDA) is warning about vulnerabilities that may introduce risks for certain medical devices and hospital networks. A security firm has identified 11 vulnerabilities, URGENT/11, that may allow anyone to remotely control a medical device, change its function, interrupt service, or cause information leaks or logical flaws.
These vulnerabilities exist in IPnet, a third-party software component supporting network communications between computers. Though the IPnet software may no longer be supported by the original software vendor, some manufacturers have a license that allows them to continue to use it without support. Therefore, the software may be incorporated into other software applications, equipment, and systems which used current medical and industrial devices.
Medical device manufacturers are actively assessing which devices using these operating systems are affected, identifying risk and remediation actions. FDA officials expect additional medical devices will be identified.
Phillips Precision Medicraft: Family culture, advanced technology for medical manufacturing
Features - Cover Story
“When you’re a leader, that just means you’re the guy at the front of the rope, pulling along and setting the direction. It’s all the people behind you who are doing the work. The people here at Phillips are the ones who built our culture and they’re the ones who sustain it.” — John Phillips, President of Operations, Implant and Instrument Division, Phillips Precision Medicraft
John Phillips, Phillips Precision Medicraft’s (PPM) president of operations for the implant and instrumentation division (center) pictured alongside two PPM machinists and the company’s Traub TNL20-9 sliding-headstock lathe.
PHOTO COURTESY OF INDEX CORP.
As John Phillips, president of operations, implant and instrument division, Phillips Precision Medicraft (PPM), walks through the manufacturing facility, he notices and questions everything, possessing a near encyclopedic knowledge of the company’s products, processes, and staff. He greets everyone he sees by name, often accompanied by a question. Why is a part that size being run on that machine? Is there a way to bring a secondary process closer to a machine? How is the tool life on a new job?
Detailed, enthusiastic answers to these questions demonstrate a strong testament to John’s engagement with the staff. But more impressive are the questions and suggestions employees proactively mention to him as he walks the shop floor, reinforcing their investment in driving the company’s efforts for constant improvement. It wasn’t always this way.
“I like to say when I started learning about lean methodologies, it was like getting a new pair of glasses,” John says. “All of a sudden all these things we were doing looked different to me and I wanted to jump in and change them. You start doing that and it’s going to upset people at first. People accept and adjust to change at different paces, so you get some people who are onboard early, but the majority are going to push back for a while.”
John would walk the floor with a pedometer, tracking the distance a part traveled on its path to completion and pointing out that it often had to be measured in miles. He spent days on the shop floor, working next to machine operators, asking questions and seeking their input. As employees realized their opinions and ideas could fuel the company’s success, they participated with a growing level of enthusiasm.
Advanced equipment
PPM further empowers staff by investing in new, advanced technology. If related cost savings and increased throughput can offset additional expense, then it’s deemed an improvement worth pursuing. This was the case with the purchase of a Traub TNL20-9 sliding-headstock lathe from Index.
In 2008, Jason Chomenko started as a sales engineer at Single Source Technologies, the distributor representing Index in New Jersey. Shortly thereafter he began calling on PPM, eventually earning their business for EDM consumables. As the company’s culture transformed, he began looking for applications where investment in advanced machine technology could further PPM’s goals. He noticed one such opportunity in late 2017.
A family of titanium bone screws were being run across Swiss machines with secondary milling operations performed on a machining center. With a total cycle time of 18 minutes, the parts had four machines at full capacity. In addition, the bone screws had to be transported between workstations and set up multiple times. Chomenko reached out to Index to evaluate the application.
“We often have the most success with projects where a customer is using not necessarily older machines but multiple, somewhat simple machines to generate a part,” says Tim Pottridge, Index regional sales representative. “That’s what we look for and that’s what Phillips had. I knew we could incorporate those processes into one machine and significantly impact the company’s manufacturing speed and output.”
Index identified the Traub TNL20-9 as the machine for the job. The sliding-headstock lathe provides simultaneous machining with up to three tools, high dynamics, 20mpm to 40mpm traverse rates, exceptional vibration damping, and high rigidity for optimal workpiece quality. Index completed a study on the part family and quoted a cycle time to PPM.
“They came back with a cycle time quote that was so low I didn’t believe them,” John says. “I’ve seen a lot of companies come back with these types of quotes that sound too good to be true and they pretty much always are. Index proved it out, showed the savings justified the investment, and that was it. They earned the sale.”
The TNL20 has two identical work spindles and two tool turrets, each with X-, Z-, and Y-axis, and can be equipped with a front- and back-working attachment.
PHOTO COURTESY OF INDEX CORP.
Phillips Precision Medicraft (PPM) performs part cleaning next to the Traub TNL20-9.
PHOTO COURTESY OF INDEX CORP.
Improved efficiency
Beyond cycle time, the new machine provided other immediate benefits. Four machines were freed up for other work. Two operators had been required previously and the new process only required one. Parts no longer had to move through the shop, sit in a queue, and have multiple setups. Additionally, PPM was notified that its customer was transitioning the family of bone screws from titanium to cobalt chrome. The rigidity and power of the machine enabled that change without sacrificing performance. For many shops, this combination of outcomes would be enough. For Phillips, it was only the beginning.
“The TNL machine is good enough that it’ll run through a 12ft bar without us having to open the door for anything,” John says. “So, we’ve got an operator there, but they’ve got a lot of free time. How do we get better from there? We start looking for secondary processes that can be done right there at the machine instead of having to be shipped off to a different department.”
PPM purchased additional equipment to perform inspection, deburring, and cleaning and placed it next to the TNL20-9. When screws leave the cell, they don’t require secondary operations, creating greater efficiency for the company and freeing up resources in other areas. Demand for the part family is rapidly increasing and PPM recently received its second TNL20-9. This level of investment in technology is happening throughout the company.
“For most of our growth over the past five years, we’ve sustained it by buying machines that can incorporate multiple processes to completely cut parts in one setup,” John says. “We’re just going to keep investing. We’re at capacity for floorspace, but when we can take out four or five machines and put in one machine to replace them, we’ve got a lot of growth potential without having to expand our footprint.”
The willingness to purchase advanced technology and reorder its operations has inspired and enthused PPM’s employees. Not only do they see the results of their suggestions, but they benefit from increasing and diversifying their skill sets.
“We love providing a good workplace and good jobs for our people,” John says. “We’ve got about 300 employees now. With spouses and kids, we’re touching more than 1,000 lives with an income and healthcare. That’s a beautiful thing and we’re doing it together.”
1. What are some challenges when implementing Wire and Sinker EDM operations into medical part production?
Deciding which process to use when implementing both machine types at the same time will depend on part features. Wire and Sinker EDM capability and process methodology differ, especially in the requirements for programming and workholding, so the control interface is different. To minimize training requirements, Makino developed the streamlined Hyper-i control, providing a common interface and operating method for all Makino EDM machines.
2. What are the advantages of implementing rotary tables on a Wire EDM machine?
Rotary tables allow access to multiple sides of a workpiece without another setup operation, enabling precision when machining small features that require less force than conventional machining methods. Wire EDM allows minimal force to be applied to the part, ensuring the part does not break. When implementing a new machine feature such as rotary tables, training can be a pain point. Rotary tables on a Makino Wire EDM machine offer full integration of indexing, turning & burning, and spinning with one interface for the operator. Training takes place on Makino’s Hyper-i control.
3. Why is Wire EDM medical micro-machining essential in certain applications?
Wire EDM medical micro-machining allows extremely small parts to be produced with high accuracy and repeatability. The smaller the wire, the smaller the inside corner radius achieved on the workpiece. Makino’s UPN-01 machine achieves the necessary precision required for medical parts requiring high accuracy and repeatability. With wire diameter to 15µm, Makino’s UPN-01 machine can achieve inside corner radii of 9µm.
4. What are the advantages of using an EDM Fine Hole instead of conventional drilling methods?
EDM Fine Hole drilling machines eliminate the need for additional secondary operations, such as deburring. Unlike conventional drilling, the tube used in fine hole operations does not create a burr at the end of the process. Another advantage of fine hole drilling is process repeatability. There is no need to worry about tool wear or testing speeds or feeds of extremely small drills. Fine hole drilling produces holes down to 10µm with low scrap rates.
5. Why is machine maintenance imperative in medical production environments?
Proper maintenance ensures machine longevity, maintains part quality, and maximizes throughput. Preventive maintenance on EDM machines allows small, minor problems to be detected before causing a major problem. Makino Wire EDM machines simplify the process of performing preventative maintenance. Reminders appear on the control interface to inform operators of the frequency of maintenance tasks.
Print productivity is up to 40% faster per layer than its predecessor – 3D Systems’ ProX DMP 320 – and the DMP Flex 350 enables faster time to market with lower operation costs.
The DMP Flex 350 3D metal printing solution for 24/7 production of parts up to 275mm x 275mm x 380mm is designed for application development, production, and research and development (R&D). Integrated 3DXpert software and LaserForm materials deliver high quality and productivity.
Cervical implant
Print productivity is up to 40% faster per layer than its predecessor – 3D Systems’ ProX DMP 320 – and the DMP Flex 350 enables faster time to market with lower operation costs. The system’s improved gas flow technology ensures improved, uniform part quality across the entire build area – even for parts made with challenging alloys and extremely dense, pure metals.
The machine delivers a pure, low-oxygen environment during printing (fewer than 25ppm), providing repeatable, high-quality microstructures and high part density. These mechanical properties ensure consistent accuracy from one job to another.
For high levels of throughput, the DMP Flex 350 offers fast, bidirectional material deposition, and user productivity is accelerated by optimized printer use, short changeover time, and enhanced scanning strategies.
Recent shutdowns of ethylene oxide (EtO) plants in the U.S. and limited worldwide availability of cobalt-60, are rapidly changing the medical device sterilization market.
The EtO closures have raised the need for FDA-cleared technologies as replacements. With limited options available to meet demand, an existing technology offers an alternative: medium-voltage electron beams. Intermediate level of penetration makes the beams relevant for sterilizing medium- and low-density products and high-density devices when repackaging is an option.
Medium-voltage electron beam technology fits terminal sterilization of packaging materials and sterile barriers; implantable medical devices; combination, commodity healthcare, and single-use products; pharmaceuticals; dressings; and biomaterials. The technology is also compatible with sterilizing human tissues, controlled substances, and drugs.
Intermediate energy
Most electron beams used for bioreduction or sterilization of medical devices are high-voltage electron beam accelerators, typically of 10 mega electron volts (MeV), due to their superior penetration.
Medium-voltage, intermediate energy, electron beam accelerators emit radiation via high-speed electrons with 0.5MeV to 5.0MeV energy levels. While the energy dictates the penetration in medical devices, medium-voltage technology features high throughput, with 150kW beam power, compared to 10MeV machines which typically operate at considerably lower beam power. Throughput capability is proportional to kW.
Processing medical devices using medium-voltage electron beams is U.S. Food and Drug Administration (FDA) cleared and applicable when applied to medium- and low-density products, as well as combination devices, in current package configurations. At higher densities, sterilization is possible but often requires repackaging. The comparatively isothermal character of electron-beam processing is also crucial for several products, especially heat-sensitive ones.
Higher throughput makes medium-voltage electron beam technology cost- effective compared to high-voltage, low-kW beams. The lower energy levels involved cannot induce radioactivity in any material, so no radioactive waste is generated.
Sustainability, effective alternative
While there are advantages, medium-voltage electron beam technology is not suitable for the sterilization of every medical device due to penetration limits.
For packaged medical devices with relatively homogeneous internal densities, package height limitations for a medium- voltage electron beam are approximately:Incompatibilities may arise from product density and disposition in the secondary package, or depending on the container in which they are stored. Product composition may also impact the feasibility of the process as some materials are radiation-sensitive, but users can adjust some parameters or the processing conditions to make the process gentler and more suitable for the material’s needs.
Converting to a different sterilization technology is not simple, fast, or inexpensive, but the reduction in conventional options is driving change. EtO facility closures have already created shortages of some medical devices, but considerable sterilization capacity is available.
About the author: Gustavo Varca, B. Pharm, PhD., is a manager of new applications development at E-Beam Services Inc. He can be reached at gustavo.varca@ebeamservices.com.
Elizabeth Engler Modic (Posted by)
Incompatibilities may arise from product density and disposition in the secondary package, or depending on the container in which they are stored. Product composition may also impact the feasibility of the process as some materials are radiation-sensitive, but users can adjust some parameters or the processing conditions to make the process gentler and more suitable for the material’s needs.
