中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

Suzhou lnternational Expo Centre B1-E1

Current Events: A Roundtable on Custom Medical Electronics

2022-09-15

Electronics manufacturing has been quickly evolving over the last few years. For one, the electronics industry has been increasingly adopting Internet of Things (IoT) technology to interconnect different equipment networked though an internet connection. Using the technologies has impacted manufacturers by reducing cost, fostering product innovation, boosting efficiency, and improving safety.

Predictive maintenance has also been a boon to electronics makers, helping them to prevent costs associated with machine downtime as well as potentially reducing repair and maintenance costs. A lot of this work is made possible thanks to IoT tech that can track equipment health, predicting how equipment might fail, and helping businesses avoid it.

These are merely a few of the recent tools in electronics manufacturers’ belts—and in the highly regulated custom medical electronics landscape, tools to ensure quality and repeatability are paramount. Making electronics used in medical devices—many of which are highly customized orders for a single application—is also highly affected by the medtech industry’s macro trends.

The ever-shrinking form factor of medical devices is a key challenge makers of medical electronic components must tackle. Minimally invasive procedures and patient discretion are driving smaller and smaller architectures with even tinier electrical components and manufacturing partners specialized in making these components are working to meet the demand.

To gain more insights on the various market trends and challenges affecting the custom electronics industry for medical devices, MPO spoke to the following experts over the past few weeks:
• Brian Allen, development director at Minnetronix Medical, a St. Paul, Minn.-based design, development, and manufacturing partner to medical device companies.
• Peter van Beek, business development manager—medical and Biren Patel, business development manager mobility solutions and electronic systems, at maxon precision motors, a Taunton, Mass.-based provider of high-precision drive systems.
• Juan Contreras, senior product manager, medical interconnect at Carlisle Medical Technologies, a St. • Augustine, Fla.-based designer and manufacturer of high-performance product solutions for the medical device market.
• Ben Dose, director, new product management for Nortech Systems, a Maple Grove, Minn.-based full-service electronics manufacturing services provider of complex interconnect solutions, diagnostic repair, and integration services.
• Darrell Goff, application engineer at ATL Technology, a Springville, Utah-based development and full-service manufacturing partner to medical device OEMs.
• Steven Lassen, senior customer application engineer at LEMO USA, a Rohnert Park, Calif.-based designer and manufacturer of precision custom connection and cable solutions. • Angel Lasso, senior director of engineering services at Jabil, a St. Petersburg, Fla.-based full-service manufacturing partner to various industries.
• Joe Tam, assistant director of R&D at Providence Enterprise, a Hong Kong-based full-service global electro-mechanical contract manufacturer.

Sam Brusco: What factors must be taken into consideration when designing and/or manufacturing custom electronics for medical devices?

Brian Allen: The required clinical outcome has to be paramount in the design. A skilled partner can help develop and reduce your idea to practice but the clinical need and the parameters around that must come first. In manufacturing, there are two primary factors: the first is component selection with an eye toward understanding what, if any the supply chain challenges will be; the second is understanding the volume potential as early as possible. That will inform design for manufacturability and the associated custom manufacturing processes needed.

Peter van Beek & Biren Patel: The class of the medical device is critical to know prior to designing and manufacturing. Drive electronics built per industrial standards are typically okay to use initially, but later require some level of customization. There are safety features built outside of the drive electronics. The drive electronics are not the final decision maker in most medical devices, they are simply there to drive the motor(s). There’s typically a host monitoring how the motor is behaving and can turn power off to the drive if necessary. Heat dissipation is another key factor, especially for handheld medical devices and robotic end effectors. For battery powered devices, high-efficiency DC motors must be used, and in maxon’s case, this results in a low inductance winding. To keep current ripple low (which is a heat driver) an efficient motor driver with appropriate filters is needed, which our drives contain. Our controllers are designed to drive maxon’s and or other low inductance motor designs.

Juan Contreras: When designing and/or manufacturing custom electronic components, performance and reliability are the most critical areas of success in achieving the expected product performance for a medical device. When a component needs to achieve a technical property, it must have the ability to do so 99.9% of the time. It’s critical to ensure the component manufacturers have a reputation of providing reliability components for high-performance medical devices. One example is the challenge of surgical/endoscope applications, which require cleaning with a broad range of chemical and sterilization with either NX100 or steam—often with the requirement of withstanding 1000 sterilization requirements. Designing with the correct materials are key in meeting these rigid requirements.

Ben Dose: As a contract manufacturer, Nortech considers future obsolescence, standardization, and serviceability as key components in a design for manufacturability solution.

Darrell Goff: When it comes to the interconnect, we will need to know what voltage the device requires. IEC 60601 is the standard medical device manufacturers must follow to ensure the electrical interconnect’s safety and efficacy meets all regulatory criteria. Ensure any electrical conducting metal is spaced far enough apart to prevent arcing, dielectric breakdown, and inadvertent patient harm. Active contacts must also be separated by specified minimum distances from electrical contacts that will come into contact with patients. Addressing these issues at the beginning of the design process reduces development time and increases design robustness. The voltage requirements will also affect the size of the connector.

It’s also important to consider the signal integrity that needs to be maintained. Many complex and demanding medical devices require that sensing signals from the heart, brain, cameras, ultrasound transducers, and other technologies are protected from the distal tip back to the capital equipment. The operating suite can be full of electrical noise from magnetic positioning systems, OR lights, and radio frequency ablation systems, among others. To ensure wires are designed to protect each signal, signal integrity must be considered at the beginning of the design. There are many ways to address this concern during the design process, including coax cable assemblies, shielded twisted pair assemblies, or differential pair cables. When understanding the device’s signal integrity needs, it’s also critical to understand ongoing test requirements.

Steven Lassen: When designing custom connectors, in addition to the standard considerations for user and patient safety, ergonomics is important, taking into consideration the long hours a surgeon is operating. Lightweight and small connectors contribute to less fatigue. The higher voltages used for the newest pulsed field ablation (PFA) electrophysiology catheter procedures require more intricate connector designs to protect the user and patient.

Angel Lasso: With slightly longer than average development times in the healthcare industry, components must be critically selected and architected to mitigate manufacturability risks. Based on time-to-market needs and technical risks, the initial development should utilize off-the-shelf components. However, these may not provide the ultimate required functionality—a semi-custom or custom approach may be needed to achieve the required functionality. For these cases, the component’s lifecycle, road maps, the understanding of which industries drive the required component (e.g., volumes, cost, and technology maturity), as well as the uniqueness of the custom component selected, must be considered during development.

Joe Tam: Specific application/intended use, power consumption, heat dissipation, technical parameter specification, accuracy, reliability, biocompatibility, relevant regulations, and standards and device classification.

Brusco: What business/operational flexibilities are necessary to manufacture custom electronic component orders for medical devices?

Allen: A good, long-term manufacturing partner will have a diverse set of validated manufacturing processes to accommodate various customer needs. Those processes, along with the experience of the manufacturing team, should be able to scale from clinical investigation volumes to full commercial production volumes and be matched by good planning and supply chain management.

van Beek & Patel: The FDA risk class of the device (I,II, III) requires us to qualify and validate to different quality levels (IQ, OC, PQ) and structure change control accordingly. Depending on the medical device and location of the drive electronics, an additional step of coating or potting of the drive electronics may be necessary. This is done to protect the board and prevent any shorts due to fluid ingress. Special motors, gear, and sensor or complete mechatronic subassemblies, which are designed for repeated autoclave sterilization are needed. Robotic systems—in particular end effectors—are demanding weight reduction wherever possible. This could concern a custom electronics design and or the drive assembly. Companies must also be open to entry of regulatory bodies to review validation and quality systems.

Contreras: There has been a constant shift in the relationship between medical OEMs and contract manufacturers (CMs). The evolving landscape and pursuit of manufacturing efficiencies, coupled with cost savings, continues to be a requirement. As such, continuous requests occur from OEMs for CMs to provide a full turn-key device, which would include development, component manufacturing, and finished device assembly.

As a CM, there will be a need for broad manufacturing capabilities that allow many technologies and components to be integrated into a single product. Ideally, these capabilities are all in one location to minimize logistical challenges and cost. In addition, a need for well-defined QMS to ensure product development and manufacturing are fully compliant but flexible enough to seamlessly complement the customer’s QMS requirements. This will include critical focus on medical device requirements for high-end performance coupled with reliable continuity of supply, strict change control, and lifetime support.

Dose: Supply chain expertise and healthy supplier relationships are absolutely crucial, as are excellent management of manufacturing capacity, including a sharp focus on skill set development, talent recruitment, and retention. A robust and flexible quality management system is the backbone of the manufacturing process as well.

Goff: When it comes to deciding between custom solutions versus off-the-shelf, customers are typically concerned with cost effectiveness and lead times. However, the payoff in performance of having a custom designed interconnect solution and device for a specific application outweighs those concerns. This is especially true when considering the volumes. We find the payback of customer devices versus off-the-shelf can be as low as 10,000 units. This includes custom connectors, cables, and molded plastics. During the current socio-economic climate, lead time is a big concern and a risk we work to mitigate. EEPROMs and microprocessors can have significant lead time—up to a year or more—but there’s a light at the end of the tunnel with most manufacturers indicating they can bring lead time down with additional capacity by 2024.

Lassen: Managing the supply chain in today’s world can be challenging. The ability to be agile in researching, recommending, and testing alternative active devices used in connectors is critical to keeping production lines moving. Even sourcing raw materials used in connectors such as metals, plastics, and plating materials—all while maintaining the high quality expected by customers—can be a challenge.

Lasso: Having an expanded bill of materials (BOM) with off-the-shelf components provides a desirable level of flexibility for operations seeking to mitigate assembly risks. However, in some cases, when unique or specialized custom components cannot be avoided to achieve the desired functionality, the product must be designed in a way that increases operational flexibility through a modular approach.

Brusco: What are customers demanding or expecting in their custom electronic components?

Allen: Our customers are heavily invested in understanding the supply chain issues around their products. They expect (and we provide) an experienced supply chain team as well as a solid and diverse network of suppliers, and an engineering team that is very creative in finding design solutions to eliminate issues that arise with supply of certain components.

van Beek & Patel: Ease of connectivity, fast setup, and ease of use. Drive electronics must be configured to the motor they will drive in either a torque/speed or positional manner. Providing customer-specific firmware to the customer already installed into the drive electronics allows for immediate use in production. Customers are demanding customized hardware layout to fit into a specific form factor to allow other drive electronics to fit into surrounding areas. Weight is also in some cases reduced. More use of FLEX cabling both for motors and drive electronics, and customers often request selected connectors.

Contreras: A continuous demand for core competencies, such as development engineering and high-end manufacturing capabilities, which lend to vertically integrated high-volume manufacturing.

Goff: Quick-turn functional prototyping capabilities are becoming more of a customer expectation. When used strategically, prototyping can help accelerate device development and decrease time-to-market, because it enables validating your ideas faster than a drawing or specification sheet. With validating ideas and concepts faster, the end customer’s inputs are realized and shared with colleagues and healthcare practitioners. Their feedback can be collected and applied to final designs. Strategic prototyping can also help identify design problems and opportunities early, enabling the customer to streamline the development process and save organization time and resources.

In relation to the interconnect design conversations, customers are looking for a variety of options. They want early ideation on connectors that meet size, creepage and clearance (IEC 60601), and sterilization compatibility. In terms of cable, everyone is demanding flexibility with reduced size, which means fine wire termination (38 AWG and smaller), and micro coax bulk termination (38 AWG and smaller) capabilities.

Lassen: We start out with a baseline of a proven, reliable connector platform, then we can integrate the customer’s custom designs within that platform from the connector to the cable and cable assembly. This gives the customer confidence and a degree of flexibility during the design process.

Lasso: More healthcare customers are moving toward consumer-style devices, such as products that are connected, more portable, or have a “cool” factor. This trend challenges healthcare device manufacturers since these products often require custom componentry, are subject to changing market conditions, or integrate technologies that are themselves undergoing rapid evolution. A custom or semi-custom approach is preferred, which will better provide the necessary risk mitigation for their manufacturing. Modular designs and architectures are a more practical way to provide the flexibility needed to merge the specific consumer-focused desires while satisfying broader healthcare industry needs.

Tam: Performance, safe and effective, accurate, reliable, upgradable, easy to use, meet relevant standards, low life cycle cost, ability to meet demand in a short period of time, and that the user can directly feel all these factors in a product. AI and IoT technologies are ways to make high technology products simple and expand the range of users. Good performance and low lifecycle of cost can keep users continually using and buying the product, as well.

Brusco: How is IoT (Internet of Things) influencing custom electronic component development and manufacture?

Goff: IoT has been instrumental in enabling home healthcare and remote patient monitoring. This shift has pushed for more consumer-friendly device designs. These designs require more attention up front when working on the industrial design, consumer use cases, and ensuring consumer-friendly workflow patterns. Consumer-friendly design means the devices are aesthetically appealing for day-to-day wear and don’t impair or hinder daily life. These devices must have Bluetooth enabled technology to allow for interfacing with cell phones to send/receive data, support the application, and control the device.

IoT has also influenced the market to trend towards more connected or intelligent medical devices, which can present many challenges. The three most common are:

Data Accuracy/Integrity: Is the data being collected also being transmitted without interruption or error? Medical device engineers should be aware of potential data collection and transmission errors to build appropriate systems to mitigate the risk.

Security: Engineers should be aware of the potential for cybersecurity vulnerabilities and how to combat them.

Compatibility: It is key to develop with industry connectivity standards in mind, so the network of devices can all “speak” to each other.

Lasso: Medical devices typically include a sensor ecosystem in addition to the main device. A complex integrated device, such as dialysis equipment or diabetes devices, will include a sensor ecosystem surrounding the device. The dialysis ecosystem includes a dialysis instrument, blood pressure monitor, patient weight scale, and hematocrit sensor. The diabetes ecosystem may include a patch pump, glucose monitor, patient weight scale, and blood pressure monitor. All these distributed systems utilize the IoT framework to provide a simple connection to all the devices. The data collected by these digital healthcare devices provides a complete picture to the healthcare provider to assess treatment efficacy through the cloud. The IoT enables and simplifies connectivity. Without it, healthcare decision-making and care delivery becomes more complex, and may only provide an incomplete or partial picture of patient status.

Tam: Developers and manufacturers of electronic components have been made to consider flexibility and adaptability to have the electronic component be compatible with other components with IoT capability. IoT can offer more possibilities for smart products; all kinds of data can be collected and delivered via internet and help development become more efficient. For the manufacturer, IoT technology can help to find out the bottleneck of the process, improve the manufacture efficiency, diagnose the machine’s failure cause, and help shorten machine downtime.

Brusco: How are requests for low power design impacting custom electronics development and manufacture? Lasso: Fast evolving industries like consumer electronics or automotive are driving the innovation and development of the next generation of healthcare products. These faster moving industries drive component road maps, cost, and availability. Healthcare has no choice but to implement ways to keep up, however they must do so while maintaining their product’s safety and efficacy. Low power is just one of several technologies healthcare has been adapting.

Tam: Implementation of low-power design poses a great challenge to developers, as they need to apply optimization at all design stages. Design parameters must be scaled down without compromising performance or characteristics. As low-power design will lead to use of small-size components; new ways of handling and placing very small components must be developed. Test strategies have to be customized—manufacturers will have to develop more innovative manufacturing processes and utilize more advanced automation equipment.

Carbon neutrality is a worldwide agreement and low-power design decreases energy consumption, so many technologies and electronic components have been developed in these years like low power consumption CPUa, Bluetooth, Wi-Fi, power supplies, and GaN components. High integration is a method for low power design. For the manufacturer, it pushes the supplier to improve their manufacturing process and skill to face this challenge.

Brusco: Is the trend toward miniaturization of medical devices driving a need for flexible, custom electronics?

Allen: Honestly, the fundamental design principles are similar. The challenge is pushing the envelope with materials and manufacturing processes more than the design. The design of miniaturized devices is one thing, the design of miniaturized components requires significant materials engineering. Putting these assemblies together requires new ways of thinking about manufacturing and manufacturing processes.

van Beek & Patel: Yes, the trend has continuously been to manufacture both smaller drive assemblies and electronics. This allows for lighter, more versatile, smaller entry points into the body, and a device that’s usable to a wider range of surgeons.

Goff: Absolutely! The technology available in these micro sizes is getting more and more advanced all the time. One example is flexible PCBs, which can be designed as thin as 0.1 mm to preserve valuable space for lumens, positioning sensors, or illumination. From a miniaturization perspective, we are also seeing consolidation of multiple components into one. For instance, ATL’s Ultra High-Density connector can robustly transfer signals over 200 discrete signals in a single, small footprint connector.

When it comes to imaging and access, vision is being added to devices where it wasn’t previously possible. To meet this demand, cameras must continue to shrink in diameter and cost while delivering increasingly high-quality images. We work with camera assemblies that can fit in a 2-5 Fr catheter. To overcome the challenges associated with miniaturization—without sacrificing quality and performance—specific engineering and manufacturing techniques must be utilized to ensure optimal performance. The camera and LEDs must be mechanically mounted within a small tip and micromolding is needed to create complex shapes.

Lasso: Miniaturization drives the need to utilize flexible and printed electronics. Custom electronics can be placed directly on textiles, affixed to blood bags, or in bandages. Low power, printed electronics, and additive manufacturing are all key technologies available to leverage in new product development.

Article source: MPO