The evolution of medical device safety has been in motion since 1968 when the U.S. Food and Drug Administration (FDA) first became responsible for medical device regulation. In the last three decades, technology-powered medical devices have exploded into clinical practice with a persistent need to evolve and become safer for a more diverse and less technically sophisticated range of users. As medical device technology matures and the technology becomes more capable, it also becomes more complex, requiring safety mechanisms that do more. Safety features iteratively improve, as implementations become more nuanced, sophisticated, and context-aware, but the underlying safety principles being applied remain surprisingly constant.
Navigating speed, safety
The Moore’s-Law-esque advance of technology (microprocessors doubling in power every 18 months for the same cost) has dumped many high-powered tools on developers and designers – multi-core processors, novel transducers, redundant electronics, and abundant communication connections. In parallel, the FDA and other regulatory bodies are elevating safety expectations of medical device manufacturers through guidance, initiatives, and standards such as IEC 14971 (risk management) and the recent recognition of IEC 62366 (human factors and user experience).
The confluence of these forces results in safety systems in medical devices trending away from piecemeal, ad-hoc solutions and toward coherently conceived, self-reinforcing, multi-tiered systems.
Common safety principles
Safety features in a medical device are often extensions of a core principle that’s fairly intuitive. Principles such as double-check your input and isolate what’s critical are very relatable, and in some cases, may be obvious. Principles such as fail safely are a little more forward looking, but obvious in retrospect. The application of these principles changes throughout time, commensurate with the toolset that the technology curve provides.
The sidebar (page 11) shows six common safety principles and descriptions of how they might be applied, referencing the technologies that make them possible. These principles tend to be application agnostic and are implemented in hardware and software. Each should be carefully evaluated when designing a new medical device.
Evolving medical device technologies require standardized, detailed safety systems to ensure product safety and quality.
The takeaway
With medical device safety, a few trends seem inevitable. Users’ expectations will elevate, technology will grow more complex and more capable, and safety solutions will evolve to become more comprehensive. While the implementations shift, these principles seem positioned to persist, as each is simply a categorical solution to the eternal question: “What happens if ___ fails?”
About the author: Milton Yarberry is the Director of Medical Programs at Integrated Computer Solutions, Inc (ICS). He is a certified PMP with a background in software architecture, medical device product development and program management. He spent a decade in consulting working with startup companies, and 15 years working with Class II and Class III medical device manufacturers. He can be reached at myarberry@ics.com.
All photos courtesy of ICS
Additive Manufacturing: Exciting reality for the biomedical industry
Features - Cover Story
Medical manufacturers want open-source options for 3D printing materials, systems, survey data show.
Blake Teipel, Ph.D., CEO and Co-founder, Essentium
The world-changing promise of additive manufacturing (AM) has been held back by scalability challenges, but the latest 3D-printing platform removes that barrier, enabling a compelling alternative to traditional machining that can bring far reaching economic, innovation, and environmental advantages.
In the biomedical industry, AM can be a game changer. For example, orthotics and prosthetics (O&P) is an inherently custom industry where devices are handmade for each patient. While practitioners take great pride in the prosthetic sockets they make, traditional processes can take days or weeks for patients to get outfitted with a custom prosthesis.
AM enables practitioners to rapidly develop cost-effective, fully customized prosthetics. It expedites the prosthetic design and production process while still allowing practitioners to make each device unique. Today, a 20-step process can be reduced to three or four steps, saving time, labor, and money. Clinicians can increase efficiency up to 400% with AM – dramatically increasing the number of patients they treat in a year.
The next generation of AM innovation is poised for rapid adoption as companies strive to respond faster to customer needs. It’s only a matter of time before the world of manufacturing and industry products are transformed for the better. But where are companies in the AM adoption process and what impact it is having on industries?
Additive manufacturing (AM) is enabling more functional prosthetics that have shock absorption and carbon-fiber blades (or feet).
ALL PHOTOs COURTESY OF ESSENTIUM
Essentium’s filaments offer strength and durability for a range of applications.
Growth in AM at scale
Recent research commissioned by Essentium exploring the attitudes of AM stakeholders shows large-scale production with additive technologies as a reality, giving companies ways to become more competitive globally.
For three decades, 3D printing has been broadly used to create prototypes. Today, more companies are pushing the boundaries beyond simple prototyping and implementing 3D printing across the entire manufacturing process – creating manufacturing aids, tooling, limited-run production parts, and full-scale production parts. Research indicates an increase in non-prototyping areas of 3D printing, with a significant spike for full-scale production parts – from 21% in 2018 to 40% in 2019.
Research also reveals that two-thirds of companies have more than doubled industrial-scale AM in their manufacturing, and 47% are using the technology for runs of thousands of printed parts, a jump of 17% compared to 2018.
The biomedical field will attract the most interest based on benefits AM offers for mass customization and improving customer response times. Survey results show the majority of respondents (61%) are adopting the technology to reduce lead times, 59% believe they will benefit from mass customization, 59% are looking to increase speed-to-part/device production, and 51% want to achieve high part/device performance.
Biomedical applications
Essentium’s High Speed Extrusion (HSE) 3D printing platform uses an all linear servo motor X-Y stage, 3G acceleration, and 1m/sec speed, eliminating wasted printer movement.
While AM stakeholders overwhelmingly agree on the benefits and impact of industrial 3D printing, they also have a common view on the challenges it must overcome to deliver on its promise. The high cost of 3D printing materials was cited by 51% as a key challenge hindering adoption, while 38% called out expensive 3D printing hardware.
The majority of 3D printer vendors adopt a closed system, locking customers into vendors’ hardware, processes, and materials. While vendors argue this ensures consistency and reliability, it forces the customer to buy materials only from their 3D printer vendor. However, Essentium’s research shows this strategy isn’t working for manufacturers. While 85% of manufacturers reported that industrial-scale AM has potential to increase revenue for their business; 22% said vendor lock-in limits flexibility. To be competitive, large production manufacturers are demanding open materials for differentiation, cost, and scale. Nearly all (99%) of executives surveyed believe an open ecosystem is important to advance 3D printing at scale.
In an open ecosystem, 3D printing platforms can use materials from various vendors to give companies greater innovation control, more choice in materials, and economical industrial-scale production.
For the biomedical industry, this will easedesign and power creativity. For example, patients today want access to more functional prosthetics – from dynamic legs with shock absorption and carbon-fiber blades (or feet) to bionic arms with nimble fingers. An open ecosystem can support designing parts that can interact with the human body and more accurately mimic human anatomy. Already we’re seeing medical applications such as anatomical replicas that serve as critical surgical learning tools, implants, and hearing aids.
As materials improve and the technology evolves in an open market, AM will lead the way, delivering innovative new devices and pushing the boundaries of what’s possible in the biomedical sphere.
The Nakamura-Tome JX-250 high performance multitasking turning center offers a large machining envelope for high-precision milling and turning of complex parts, along with a twin lower turret configuration for flexible, complex component manufacturing. The Nakamura JX-250 features NT Smart Cube tool spindle, a 12,000rpm tool spindle permitting maximum part length on the left and right spindles, including when the horizontal tool spindle and lower turrets are in the cut.
To optimize part transfer, independent right spindle guideways on lower turrets minimize distance between the spindles to 11.8" (300mm). For high processing flexibility, a single or twin lower turret design is offered with overlapping travels and Y-axis box guideways are standard. The multitasking machining center provides up to 168 tool stations.
The Nakamura JX-250 has a maximum turning diameter of 12.6" (320mm) and a maximum turning length of 65" (1,650mm). The left and right spindles have 3” (80mm) and 2.5” (65mm) bar capacity, respectively. Tool spindle X, Y, Z travel is 25.4" x ±4.9" x ±32.5" (645mm x ±125mm x ±825mm). The B-axis tool spindle positioning range is 240°.
The JX-250 features a SmartX PC-based 19” high-resolution color touch screen, which works in conjunction with the Fanuc 31i-B5. A 5-axis precision milling software package ensures optimal 5-axis milling.
Engineered for finishing medical devices, implants, and tools, compact drag finishing systems remove excess metal up to 40x higher than conventional mass finishing. The small-footprint machines provide gentle surface finishing for delicate components that cannot touch during processing.
Rotary carousels with up to six spindles drag fixtured parts through the media mass, preventing high value, sensitive parts from touching and potentially damaging each other. Rotation of the carousel and spindles guarantee even parts treatment.
Compact drag finishers use frequency inverters to control variable rotary speeds of carousel and spindle drives. The main drive unit provides up-and-down movement. Machine options include four or six spindles and work bowls in 700mm to 1,300mm (27" to 51") diameters. Designed for plug-and-play installation, standard features include noise-reducing enclosures, access doors with safety interlock and sliding window for easy access and operation, and machine controls and dosing systems accessible from the enclosure.
MacBond HTA410 acrylic tapes – Double-coated or transfer adhesive constructions; Mactac HTA410 adhesive offers quick tack and peel strength; bonds well to polyether/polyurethane open-cell foams and medium- to high-surface- energy plastics; suitable for face shields
MacBond LSE427 acrylic tapes – Double-coated tape, 2.0mil transfer adhesive or 5.0mil tissue-supported transfer adhesive; Mactac LSE427 adhesive bonds to foams, plastics
MacMount Ultra 555 mounting, bonding tapes – Double-coated polyester construction or double-coated foam; 78# SCK liner and Mactac Ultra 555 adhesive provide holding power; suitable for dispensers, fixtures, protective shielding installations
MacBond foam bonding tapes – 60# or 80# liner; double-coated tapes; Mactac FBR899 adhesive (exposed side), XT Rubber adhesive (liner side); FBR899 quickly bonds to open-cell polyurethane foams; high-shear XT Rubber bonds well to smooth surfaces
Double-coated foam (TM4200, TM4230) – 1/16", 1/32" thicknesses; Mactac Acrysure adhesive liner side, Silk Adhesive System unwind side; designed for device assembly where depth is needed, electrodes, seals, gaskets
Single-coated nonwoven (TM8102) – 2.4oz white spunlace non-woven construction paired with a medical- grade acrylic adhesive; for soft coverings, electrodes, monitoring devices
1. How can Optical Gaging Products (OGP) and Quality Vision Services (QVS, is a service branch of QVI/OGP) help your operation comply with FDA and CFR standards?
OGP® and QVS™understand that medical device manufacturers must have processes that pass FDA audits. Despite many casual promises in the market, good manufacturers know that no metrology tool is “FDA compliant” on its own. It’s the manufacturer’s operations that must be qualified to FDA and CFR standards. At OGP, our equipment and software are proudly designed for use in FDA-compliant environments. Over the years, the QVS on-site service team has assisted thousands of medical device manufacturers with Installation Qualification (IQ) and Operational Qualification (OQ) of their OGP systems.
2. What does QVS’s Installation Qualification (IQ) service provide?
QVS is an ISO 17025 accredited laboratory. All OGP systems installed by QVS comply to this accreditation. Following an accredited installation, QVS is capable of conducting testing to provide IQ – verification of documentation, environment, test equipment, artifacts, materials, lubricants, and equipment installation requirements. IQ helps customers meet CFR Part 820 requirements.
3. What does QVS’s Operational Qualification (OQ) service provide?
OQ will provide verification of documentation, operational verification, process Failure Mode and Effects Analysis (FMEA), preventative maintenance schedules, and operational functionality forms. During the OQ, QVS runs numerous routines using accredited artifacts having measurements traceable to NIST or an equivalent National Metrology Institute to verify the system’s ability to accurately measure using all installed sensors. OQ helps customers meet CFR Part 820 and CFR Part 11 requirements.
QVS can provide a suggested protocol for Performance Qualification the end user can follow to demonstrate the effectiveness and reproducibility of the process, and that the process works under a full range of conditions to be encountered in production.
4. What makes OGP’s ZONE3 PRO metrology software useful in a regulated environment?
Compliance with complex regulatory requirements, such as FDA 21 CFR Part 11, requires much more than protecting passwords and restricting user access to files and folders on a corporate network. ZONE3® Pro software has built-in capabilities that directly support operational requirements of a regulatory-compliant environment.
User access permissions are directly linked to Windows® groups so specific users can be restricted from running or editing ZONE3projects. For those with permission to run projects, audit trail reporting automatically logs all user actions.
Electronic signatures of measurement results can be applied in the form of Windows user credentials or biometric data (e.g., fingerprint). Signature approvals can be controlled based on user permissions.
5. Is ZONE3 user friendly for operators?
ZONE3 Pro software contains LaunchPad, a simplified application with a highly configurable user interface that provides an operator view so those with only minimal training can launch and run programs. Setup instructions, documents, videos, and barcode identification can be added to each program.
User permissions can be set up to allow control over who is authorized to launch certain projects, the sequence in which projects are run, and the parameters within which projects may be executed.
As 3D printing has become a viable form of mass production, the need for automated mass finishing of additively manufactured parts is growing. Bel Air Finishing is a supplier of mass finishing equipment & supplies, offering the opportunity for companies to learn about mass finishing of 3D-printed parts. A Hewlett Packard (HP) PA post-processing seminar/workshop will be held Aug. 5, 2020, focusing on HP 3D printed parts and covering other 3D printing technologies. The workshop is designed to teach participants how HP 3D printed parts can be taken from a printer, processed to produce a high quality finish, and measured to qualify results. The seminar will be available online and in person.
Eaton, regional partners 3D print face shields
Cleveland, Ohio-based Eaton is using its manufacturing, 3D printing expertise, and partner network to fulfill a JobsOhio order for rapid production of 360,000 reusable face shields to strengthen the state’s fight against the coronavirus.
Eaton collaborated with multiple hospitals and Cleveland’s Manufacturing Advocacy and Growth Network (MAGNET) to optimize the face shield design for production. Eaton is now working with Thogus, a local family-owned custom plastic injection molder, to rapidly produce the critical equipment at scale.
“Ten business days ago, this project was just a concept. Today, we’re moving forward with production and looking to expand further,” says Michael Regelski, senior vice president and chief technology officer, Electrical Sector at Eaton. “By leveraging our advanced manufacturing capabilities and strong network of partners, we’re helping Ohio quickly respond to current inventory challenges and maximize accessibility of critical personal protective equipment (PPE) resources for frontline teams combatting COVID-19."
Posted by Elizabeth Engler Modic
