Sam Brusco, Associate Editor09.10.21
Radwave’s electromagnetic minimally invasive and robotic surgical tracking platform was custom designed for integration into existing surgical devices and the clinical environment. The modular platform allows rapid customization to meet OR specifications, and the field-generating antenna—which can be tuned to accommodate various sensing volumes—remains translucent amid fluoroscopy. Its frequencies can be adjusted to avoid interference with the many connected devices populating the OR environment. It’s a custom machine for the OR in every sense of the word.
Naturally, such a specialized device requires specialized components. That’s why engineered electronics manufacturer TT Electronics was recruited for the job. The company designs and manufactures custom sensors for a wide range of medical equipment, including surgical navigation. Radwave and TT’s complete navigation system can itself be customized for tracking a broad spectrum of minimally invasive diagnostic and therapeutic surgical procedures without a clear line of sight.
“Through our collaboration, this technology has incredible potential to disrupt an industry and ultimately improve patient outcomes…” TT Electronics EVP Michael Leahan told the press.
Groundbreaking technologies like Radwave and TT’s aren’t possible without manufacturing partners providing specialized electronics to power, move, maintain, or otherwise enhance them. There is consequently much fervor for medical device makers to partner with a medical electronics maker well-versed in custom products. So, in order to gather valuable insights about custom electronics design and manufacturing for medical devices, MPO spoke to half a dozen industry experts over the past few weeks:
Drew Bratton, director of business development at P1 Technologies, a Roanoke, Va.-based manufacturer of injection molded products and interconnect cables used by the medical industry.
Charlie Cassano, technical sales executive at Solenoid Solutions, an Erie, Pa.-based provider of 2-way and 3-way solenoid valves, valve manifolds, and custom valves.
Rob Clippard, chief marketing officer of Clippard Instrument Laboratory, a Cincinnati, Ohio-based designer and manufacturer of miniature fluid control solutions.
Dave Howard, business development manager at KNF Neuberger, a Trenton, N.J.-based designer, manufacturer, and distributor of diaphragm pumps and systems for handling gases and liquids.
Steven Lassen, senior customer applications engineer at LEMO USA, a Rohnert Park, Calif.-based designer and manufacturer of precision custom connection and cable solutions.
Jimmy Logsdon, marketing manager at Linemaster Switch Corporation, a Woodstock, Conn.-based designer and manufacturer of medical and industrial foot controls.
Sam Brusco: What factors must be taken into consideration when designing custom electronic components for medical devices?
Drew Bratton: First and foremost, understanding the level and risk to the patient helps classify the device into the FDA ranking system and ensure the level or review is appropriate. To list some of the inputs to our design and development process; functional, electrical, software, environmental performances, physical characteristics, user and patient safety considerations, and target cost. We have invested in developing an integrated system to guide development of complete custom medical devices following ISO 13485 guidelines to ensure no inputs are left unreviewed.
Charlie Cassano: Size constraints and power consumption are typically driving factors that designers look at first. The smaller you can make a component and the least amount of power it will consume will allow devices to be as unobtrusive as possible.
Rob Clippard: When designing any component for medical applications, we must consider what is important beyond basic performance specifications. Once the concept and initial evaluations are done to meet performance requirements, it is imperative to dig deeper into requirements beyond performance such as certifications, testing, quality documentation, and the key one—manufacturability.
Manufacturing in the machining world has several exciting trends. It’s always advancing and offering designers new capabilities for creating their vision. It is common for tolerances of ±0.005” or 0.002”, but we have many applications requiring machining tolerances for medical applications down to the tens of thousands. 3D printing is another trend becoming more affordable. Like all new technologies, it’s cool, but it’s pricy out of the gate and hard to compete with traditional manufacturing methods. It is still expensive, but for the most intricate designs, it is an attractive manufacturing method that will continue to become more mainstream as that technology advances.
Knowing the required certifications required by the application will aid in material specifications, which can alter design. Knowing the application’s testing requirements can also alter design. If the leak specification is crucial to the device, careful considerations would be made to sealing surfaces and the types of sealing design used. If any integrated electronics need to be CE tested, this again will alter the design elements to meet those specifications. Ask these questions upfront and avoid having to redesign later. Knowing upfront the manufacturing methods for any device will also help streamline the process beyond design. I have seen many projects over the years have to go back and forth between production and engineering over minor changes like tolerances and surface finishes. These additional items are critical to know in the front end of the design phase and will later pay off with a smooth process that keeps projects on time and on budget.
Dave Howard: With constant improvements in product intelligence, it is becoming increasingly more valuable to be able to monitor all electronic components on board medical devices. By taking advantage of the full capabilities and digital customization of brushless DC motor controllers, KNF offers a family of pumps that can be optimized to monitor and control pump performance, improve efficiency and accuracy, and extend the operating life of many components on board the devices. Also, with the amount of data available along with the ability to monitor, predictive maintenance, just-in-time replacement, and even self-diagnosis become more realistic.
Steven Lassen: The most important factor is patient and user safety. Means of Patient Protection (MOPP) and Means of Operator Protection (MOOP) as defined by ANSI IEC 60601-1 must be followed for any electrical components. OEMs and their suppliers must review any risk factors as well. Other factors, especially for those elements that will be in direct contact/use by the operator must be evaluated for ergonomics, weight, and how intuitive it is to use.
Jimmy Logsdon: Many key features that Linemaster considers when designing a medical-grade foot control medical devices are as follows: Medical standards; what application and OR atmosphere the foot pedal will be used in will affect the design of our controls; style/look of the foot control needs to compliment the medical device in regards to branding and colors; reliability, our foot control operates the medical device so it needs to work the first time every time. A robust design electrically and mechanically is a must.
Material of the foot control, base plate, channel, handle, base pads, divider bars. Does it need to have a foot guard? Does the foot control need handles or toe loops for ease of picking up and maneuverability?
Cable selection: Gauge, flexibility, memory; connector selection; strain relief selection; cable management.
Does the pedal have designed in ribbing for traction or a skid-free pad to ensure the doctor’s foot doesn’t slip off? Floor friction considerations so the pedal doesn’t slide around the floor while being operated.
Lighting (LED requirements): some ORs are dark and there is a requirement for lighting on the pedal.
Surface finishes: Marking (pad print, silk screen, labeling), for regulatory, branding, function indicators. Paint type, powder coat paint, colors to match the medical device typically.
Electronic lockout utilizing a tilt mechanism to shut the pedal off if tipped upside down; mechanical lockout utilizing a mechanical design feature that stops the foot switch from operating if tipped over; positive stop design, fail in the off position so the equipment used on the medical device doesn’t continue to run if something malfunctions; magnetic immunity features.
Testing required (impact, environmental, shipping, production, automated testing equipment, drop testing, water testing, cable flex testing, cable pull testing); traceability (serial labels, barcoding, Intelligent p/ns, date coding); regulatory documentation support, EU MDR labeling requirements; cleaning, storage, drainage; serviceability—a foot switch design that allows for repairs to be made when necessary.
Brusco: What business/operational flexibilities are necessary to manufacture custom electronic component orders for medical devices?
Bratton: New medical technologies are being developed on a daily basis and manufacturing capabilities must be developed at the same rate. P1 Technologies has a turnkey manufacturing model where we either grow our in-house capabilities, or we have a strong network of suppliers with the competency required. It is considerably important to succeed to have a strong business development team that continues to reinvest in new products and technologies.
Cassano: Having the ability to make a product completely in-house from design to assembly allows you to modify or change a design quickly and get those changes implemented almost immediately to production.
Clippard: Whether 3D printing, populating PCBs or machining parts, operational teams are faced with balancing safety, quality, delivery, and cost (SQDC). Operational flexibility is essential and even more complex with more custom parts. The more set-ups and changes a manufacturer encounters will lead to more cost and require a strong culture of quality and adherence to those processes.
In the medical device market, cleanliness standards and testing are vitally important. As a custom medical device manufacturer, the capability to run operations in a cleanroom environment with high standards for documentation and process control doesn’t come cheap. It’s an added complexity for manufacturers striving to maintain the flexibility needed to respond quickly to customer demands.
Another factor to consider with the flexibility of manufacturing custom components is the network around the manufacturing company. You’re not going to find a manufacturer in electronic components today that does everything, as some outsourcing of an assembly will typically need to be done. Networking becomes immensely important in your supply chain of parts, ensuring the best parts. Having a strong network of trusted partners for support is a major key in maintaining operational flexibility.
Howard: A pump manufacturer such as KNF can customize brushless DC motor parameter files to individual application requirements. This built-in intelligence along with engineering support helps customers improve their smart devices. In general, the better a component vendor understands the device and system in which their component is to be integrated, the better they can design digital and mechanical modifications that optimize their product for the application.
Lassen: For cable assemblies, often cleanrooms and sterilization equipment are a huge capital expense to consider. It may be better to subcontract out to a company specializing in cleanroom/sterilization operations.
Logsdon: Most medical device companies are looking for custom solutions, so we must conform to their requirements. This could be a ground-up design that’s completely brand new that needs tooling and board design, or could be an extension of a design we already offer, with their own twist. Ground-up designs require multiple back and forth conversations between us and our customer, doing design renderings, prototype units for testing, and validation & verification units, all before any production foot controls are produced.
Brusco: What are customers demanding or expecting in their custom electronic components?
Bratton: Customers demand more complex solutions than ever before. With new technology and software developments, components have had to shift in culture to support the vast array of new technology. Many years ago, cables and connectors were very simplistic and just a means to connect items. Many of our clients now look to combine multiple cables, electrodes, and circuitry into one complete system, whereas in the past, it may have been multiple items working in tangent. Some of these new components include electronic identification and limited-use chips making our cables and connectors become intelligent.
Cassano: Flexibility of design and true custom products, not a catalog item that comes close or a “one-size-fits-all” product. Having a product designed for the application directly.
Clippard: Without getting technical, the general demands haven’t changed much. Like all of our customers, they want it smaller, faster, and cheaper. (Thanks Amazon for changing our expectations!) Our balance of those commercial demands and clearly defining our value helps us to do an important aspect of business not everyone likes to do. (Saying “no!”) And with the yes to crazy customer requests, more functionality, in a smaller package, at less cost is where technology continues to push the envelope of what is possible.
Howard: More and more customers demand a perfect fit for their device. Off-the-shelf items no longer make the cut and even mechanically modified products fall short of expectations. Many pump companies offer a wide range of products, and while KNF continues to follow that model, we outfitted our product line with advanced BLDC motors to fill the gaps between products. We then complement this strategy with the ability to tie pumps into sensors and accessories to precisely control accuracy of flow rates and pressure requirements. In many cases, we can simplify and reduce size with our close loop smart pump system while improving precision and accuracy with real-time adjustability and control.
Lassen: Sometimes customers demand custom electronic component form factors that seem to defy physics. In those cases, innovation is key to seek alternatives or come to a compromise.
Logsdon: High-quality, ergonomic foot controls that complement their medical device. They expect our foot switches to work perfectly in unison with their medical device and provide users with a satisfactory experience. They also expect documentation support—test reports, production prints, regulatory documents when applicable, and label verification reports.
Brusco: How is IoT (Internet of Things) influencing custom electronic component development?
Bratton: The largest shift we have seen in the past 5-10 years is integration of home healthcare and data collection. Many products are shifting to allow use through small home devices such as a smartphone or a tablet. Diagnostic or monitoring tests that have historically been conducted in a hospital or clinic are now completed within the comfort of home. Many of these devices are connected through the internet, and data can be uploaded to cloud storage for further review and analysis.
Cassano: Being able to reach out to product designers and manufacturers that might have the custom solution you are looking for is much easier now with the internet and search engines. Designers can connect with producers they might have never found previously.
Clippard: Essentially what this means is connectivity, down to the component level. What is the ability to reach out to a component buried inside a system and receive feedback? More connectivity and added features a device can offer in terms of communication and protocols can help read status and even determine life expectancy. There are many applications today where we are integrating technology on the development side so customers can have that functionality in the future where they don’t necessarily need it today. Whereas developing a device today that might not spark interest, in the future that same device in a lab or hospital could be utilized in ways the end-user is yet to realize the benefit.
The big challenge I see for the IoT is security. It exists on some level today with PCs, Teslas, and large PLC-controlled capital equipment—but when my microwave or fridge or medical gas regulator hiccups and the manufacturer can directly connect to it to evaluate the device and even service it, that’s cool. However, we all understand the risk with viruses, and a bigger challenge to remote IoT is having the right level of security and access through networks to be able to communicate with the device. For now, I see IoT being utilized in a discrete network for the benefit of accessing a device and information sharing from that device. Smart homes are great examples of the acceptance of accessible devices that share information. As I am writing this from the office, my home is reading 71°F. But if my home gets hacked, I’ll manage. Medical corporations have much more at stake and will need robust device security and network policies that bring engineers peace of mind.
Lassen: Robotic-assisted surgical (RAS) systems can be manipulated remotely, whether a few steps away or over much longer distances. Using low latency components are critical to simulating an in-person operation. As wearable and portable medical devices continue to rely more heavily on wireless connections, either through 5G cellular networks or Wi-Fi, most still require a power connection for charging.
Logsdon: We offer an RF wireless technology that operates in the 2.405 - 2.480 GHz frequency band, transmitting back and forth between the foot pedal and the receiver we provide. Safety protocol with the RF signal has to be in place to ensure there is no cross-talk between our foot pedal and any other wireless equipment in the OR.
Brusco: How are requests for low-power design impacting custom electronic component development?
Bratton: Low-power electronics include devices such as cardiac pacemakers, cardiac defibrillators, neurological stimulators, muscle stimulation devices, hearing aids, bone conduction amplifiers, tinnitus blockers, and cochlear implants. Plastics One has worked with OEM companies to help develop many of these solutions. We treat power requirements as an input to the overall project success and either verify or validate the performance criteria for each.
Cassano: Lower power componentry equals lower power consumption on an overall system. It pushes the manufacturers to design ever more efficient products based on customer power requirements or limitations.
Clippard: Whether an electronic vehicle or a cell phone, consumers don’t want to be recharging their devices too frequently—you want your product to go the distance. There is a unique balance in the design of these components between functionality and how much power will be consumed. A discrete component to perform a function that would be small and efficient versus larger, more robust, and powerful chips, boards, or circuits that can be utilized in a variety of applications. Regarding battery life, I see the lower powered design becoming less of an emphasis because of the advancements in battery technology.
Howard: Whether operating off a battery or not, power draw is always a vital design element and we are always asked about maximum current draw of our pumps. What we now offer customers is the ability to limit maximum current draw or program a slow start feature to reduce initial spikes of in-rush current, just with a simple custom parameter file uploaded to motor control boards set to whatever maximum current draw is requested. This is an especially nice feature when filters could clog and cause pressure build-up within a system. In this case, a pump would normally spike in power draw.
Lassen: Lower power designs typically mean smaller packages; however, with connectors there may be a need to keep a larger size for easier manipulation by hand. In this case, we can make the electrical contacts smaller while keeping the connector size the same, and the benefit is we can include more signal or power contacts.
Logsdon: Everything wireless seems to be moving toward the need for Bluetooth low energy (BLE) for medical devices. We have the capability to develop a BLE foot control to accommodate this type of request.
Brusco: Is the trend toward miniaturization of medical devices driving a need for flexible custom electronic components?
Bratton: Medical devices are constantly undergoing design changes and improvements to reduce size. As size reduces, many performance characteristics must be reviewed and tested before production implementation. Our pre-clinical division has been at the forefront of miniaturization working with university students and doctors on cannulas and electrodes used in drug delivery systems. We have also invested in tool-making technology to help facilitate mold fabrication on a miniature scale.
Cassano: Miniaturization itself is a custom solution, as it keeps evolving based on ever-changing needs to the application. As the requirements become more stringent, the product has to keep up with the requirements as well.
Clippard: The miniaturization of medical devices is astonishing considering the advancements in chip manufacturing—the size of what they can do on the tip of your pen versus even five years ago! Moore’s law states you can expect the capability of technology to double every few years. It’s exciting to see how much technology can be integrated into a pinhead. The miniaturization of medical devices brings new opportunities in having intelligence not just around your body, but in your body. Think about pacemakers and defibrillators that are now being embedded. Custom electronic components that will be robust, protected, and rated to be in the body is a fantastic advancement we are seeing today. The need to miniaturize those things and create components that have robust cycle lives and take care of life themselves is exciting to see.
Howard: As the overall envelope shrinks, the space available for subcomponents like pumps is reduced. We like to support these applications by increasing performance of our products electronically, rather than mechanically. Motor speeds can sometimes be slightly increased to hit performance points, while also offering the ability to monitor temperatures, should things heat up with less breathing room. We offer our engineering expertise and product flexibility to design the most efficient use of space within a given device.
Lassen: Miniaturization of a medical device can be accomplished by packaging elements that would normally be arrayed on the panel into a single connector. For instance, a single connector containing power contacts, data, high voltage for pulsed field ablation, and even fiber optics or fluidic/pneumatic contacts with automatic shutoffs can be combined into a single connector. This also simplifies the operation and setup of the equipment.
Logsdon: The goal lately in the foot switch world seems to be combining different functions into one foot control, which would eliminate the need for multiple foot controls on the floor taking up a bunch of space. This is truly a user preference as to how small they would want our pedal, but our ability to spin much smaller boards gives us the flexibility to create a smaller human interface.
Naturally, such a specialized device requires specialized components. That’s why engineered electronics manufacturer TT Electronics was recruited for the job. The company designs and manufactures custom sensors for a wide range of medical equipment, including surgical navigation. Radwave and TT’s complete navigation system can itself be customized for tracking a broad spectrum of minimally invasive diagnostic and therapeutic surgical procedures without a clear line of sight.
“Through our collaboration, this technology has incredible potential to disrupt an industry and ultimately improve patient outcomes…” TT Electronics EVP Michael Leahan told the press.
Groundbreaking technologies like Radwave and TT’s aren’t possible without manufacturing partners providing specialized electronics to power, move, maintain, or otherwise enhance them. There is consequently much fervor for medical device makers to partner with a medical electronics maker well-versed in custom products. So, in order to gather valuable insights about custom electronics design and manufacturing for medical devices, MPO spoke to half a dozen industry experts over the past few weeks:
Drew Bratton, director of business development at P1 Technologies, a Roanoke, Va.-based manufacturer of injection molded products and interconnect cables used by the medical industry.
Charlie Cassano, technical sales executive at Solenoid Solutions, an Erie, Pa.-based provider of 2-way and 3-way solenoid valves, valve manifolds, and custom valves.
Rob Clippard, chief marketing officer of Clippard Instrument Laboratory, a Cincinnati, Ohio-based designer and manufacturer of miniature fluid control solutions.
Dave Howard, business development manager at KNF Neuberger, a Trenton, N.J.-based designer, manufacturer, and distributor of diaphragm pumps and systems for handling gases and liquids.
Steven Lassen, senior customer applications engineer at LEMO USA, a Rohnert Park, Calif.-based designer and manufacturer of precision custom connection and cable solutions.
Jimmy Logsdon, marketing manager at Linemaster Switch Corporation, a Woodstock, Conn.-based designer and manufacturer of medical and industrial foot controls.
Sam Brusco: What factors must be taken into consideration when designing custom electronic components for medical devices?
Drew Bratton: First and foremost, understanding the level and risk to the patient helps classify the device into the FDA ranking system and ensure the level or review is appropriate. To list some of the inputs to our design and development process; functional, electrical, software, environmental performances, physical characteristics, user and patient safety considerations, and target cost. We have invested in developing an integrated system to guide development of complete custom medical devices following ISO 13485 guidelines to ensure no inputs are left unreviewed.
Charlie Cassano: Size constraints and power consumption are typically driving factors that designers look at first. The smaller you can make a component and the least amount of power it will consume will allow devices to be as unobtrusive as possible.
Rob Clippard: When designing any component for medical applications, we must consider what is important beyond basic performance specifications. Once the concept and initial evaluations are done to meet performance requirements, it is imperative to dig deeper into requirements beyond performance such as certifications, testing, quality documentation, and the key one—manufacturability.
Manufacturing in the machining world has several exciting trends. It’s always advancing and offering designers new capabilities for creating their vision. It is common for tolerances of ±0.005” or 0.002”, but we have many applications requiring machining tolerances for medical applications down to the tens of thousands. 3D printing is another trend becoming more affordable. Like all new technologies, it’s cool, but it’s pricy out of the gate and hard to compete with traditional manufacturing methods. It is still expensive, but for the most intricate designs, it is an attractive manufacturing method that will continue to become more mainstream as that technology advances.
Knowing the required certifications required by the application will aid in material specifications, which can alter design. Knowing the application’s testing requirements can also alter design. If the leak specification is crucial to the device, careful considerations would be made to sealing surfaces and the types of sealing design used. If any integrated electronics need to be CE tested, this again will alter the design elements to meet those specifications. Ask these questions upfront and avoid having to redesign later. Knowing upfront the manufacturing methods for any device will also help streamline the process beyond design. I have seen many projects over the years have to go back and forth between production and engineering over minor changes like tolerances and surface finishes. These additional items are critical to know in the front end of the design phase and will later pay off with a smooth process that keeps projects on time and on budget.
Dave Howard: With constant improvements in product intelligence, it is becoming increasingly more valuable to be able to monitor all electronic components on board medical devices. By taking advantage of the full capabilities and digital customization of brushless DC motor controllers, KNF offers a family of pumps that can be optimized to monitor and control pump performance, improve efficiency and accuracy, and extend the operating life of many components on board the devices. Also, with the amount of data available along with the ability to monitor, predictive maintenance, just-in-time replacement, and even self-diagnosis become more realistic.
Steven Lassen: The most important factor is patient and user safety. Means of Patient Protection (MOPP) and Means of Operator Protection (MOOP) as defined by ANSI IEC 60601-1 must be followed for any electrical components. OEMs and their suppliers must review any risk factors as well. Other factors, especially for those elements that will be in direct contact/use by the operator must be evaluated for ergonomics, weight, and how intuitive it is to use.
Jimmy Logsdon: Many key features that Linemaster considers when designing a medical-grade foot control medical devices are as follows: Medical standards; what application and OR atmosphere the foot pedal will be used in will affect the design of our controls; style/look of the foot control needs to compliment the medical device in regards to branding and colors; reliability, our foot control operates the medical device so it needs to work the first time every time. A robust design electrically and mechanically is a must.
Material of the foot control, base plate, channel, handle, base pads, divider bars. Does it need to have a foot guard? Does the foot control need handles or toe loops for ease of picking up and maneuverability?
Cable selection: Gauge, flexibility, memory; connector selection; strain relief selection; cable management.
Does the pedal have designed in ribbing for traction or a skid-free pad to ensure the doctor’s foot doesn’t slip off? Floor friction considerations so the pedal doesn’t slide around the floor while being operated.
Lighting (LED requirements): some ORs are dark and there is a requirement for lighting on the pedal.
Surface finishes: Marking (pad print, silk screen, labeling), for regulatory, branding, function indicators. Paint type, powder coat paint, colors to match the medical device typically.
Electronic lockout utilizing a tilt mechanism to shut the pedal off if tipped upside down; mechanical lockout utilizing a mechanical design feature that stops the foot switch from operating if tipped over; positive stop design, fail in the off position so the equipment used on the medical device doesn’t continue to run if something malfunctions; magnetic immunity features.
Testing required (impact, environmental, shipping, production, automated testing equipment, drop testing, water testing, cable flex testing, cable pull testing); traceability (serial labels, barcoding, Intelligent p/ns, date coding); regulatory documentation support, EU MDR labeling requirements; cleaning, storage, drainage; serviceability—a foot switch design that allows for repairs to be made when necessary.
Brusco: What business/operational flexibilities are necessary to manufacture custom electronic component orders for medical devices?
Bratton: New medical technologies are being developed on a daily basis and manufacturing capabilities must be developed at the same rate. P1 Technologies has a turnkey manufacturing model where we either grow our in-house capabilities, or we have a strong network of suppliers with the competency required. It is considerably important to succeed to have a strong business development team that continues to reinvest in new products and technologies.
Cassano: Having the ability to make a product completely in-house from design to assembly allows you to modify or change a design quickly and get those changes implemented almost immediately to production.
Clippard: Whether 3D printing, populating PCBs or machining parts, operational teams are faced with balancing safety, quality, delivery, and cost (SQDC). Operational flexibility is essential and even more complex with more custom parts. The more set-ups and changes a manufacturer encounters will lead to more cost and require a strong culture of quality and adherence to those processes.
In the medical device market, cleanliness standards and testing are vitally important. As a custom medical device manufacturer, the capability to run operations in a cleanroom environment with high standards for documentation and process control doesn’t come cheap. It’s an added complexity for manufacturers striving to maintain the flexibility needed to respond quickly to customer demands.
Another factor to consider with the flexibility of manufacturing custom components is the network around the manufacturing company. You’re not going to find a manufacturer in electronic components today that does everything, as some outsourcing of an assembly will typically need to be done. Networking becomes immensely important in your supply chain of parts, ensuring the best parts. Having a strong network of trusted partners for support is a major key in maintaining operational flexibility.
Howard: A pump manufacturer such as KNF can customize brushless DC motor parameter files to individual application requirements. This built-in intelligence along with engineering support helps customers improve their smart devices. In general, the better a component vendor understands the device and system in which their component is to be integrated, the better they can design digital and mechanical modifications that optimize their product for the application.
Lassen: For cable assemblies, often cleanrooms and sterilization equipment are a huge capital expense to consider. It may be better to subcontract out to a company specializing in cleanroom/sterilization operations.
Logsdon: Most medical device companies are looking for custom solutions, so we must conform to their requirements. This could be a ground-up design that’s completely brand new that needs tooling and board design, or could be an extension of a design we already offer, with their own twist. Ground-up designs require multiple back and forth conversations between us and our customer, doing design renderings, prototype units for testing, and validation & verification units, all before any production foot controls are produced.
Brusco: What are customers demanding or expecting in their custom electronic components?
Bratton: Customers demand more complex solutions than ever before. With new technology and software developments, components have had to shift in culture to support the vast array of new technology. Many years ago, cables and connectors were very simplistic and just a means to connect items. Many of our clients now look to combine multiple cables, electrodes, and circuitry into one complete system, whereas in the past, it may have been multiple items working in tangent. Some of these new components include electronic identification and limited-use chips making our cables and connectors become intelligent.
Cassano: Flexibility of design and true custom products, not a catalog item that comes close or a “one-size-fits-all” product. Having a product designed for the application directly.
Clippard: Without getting technical, the general demands haven’t changed much. Like all of our customers, they want it smaller, faster, and cheaper. (Thanks Amazon for changing our expectations!) Our balance of those commercial demands and clearly defining our value helps us to do an important aspect of business not everyone likes to do. (Saying “no!”) And with the yes to crazy customer requests, more functionality, in a smaller package, at less cost is where technology continues to push the envelope of what is possible.
Howard: More and more customers demand a perfect fit for their device. Off-the-shelf items no longer make the cut and even mechanically modified products fall short of expectations. Many pump companies offer a wide range of products, and while KNF continues to follow that model, we outfitted our product line with advanced BLDC motors to fill the gaps between products. We then complement this strategy with the ability to tie pumps into sensors and accessories to precisely control accuracy of flow rates and pressure requirements. In many cases, we can simplify and reduce size with our close loop smart pump system while improving precision and accuracy with real-time adjustability and control.
Lassen: Sometimes customers demand custom electronic component form factors that seem to defy physics. In those cases, innovation is key to seek alternatives or come to a compromise.
Logsdon: High-quality, ergonomic foot controls that complement their medical device. They expect our foot switches to work perfectly in unison with their medical device and provide users with a satisfactory experience. They also expect documentation support—test reports, production prints, regulatory documents when applicable, and label verification reports.
Brusco: How is IoT (Internet of Things) influencing custom electronic component development?
Bratton: The largest shift we have seen in the past 5-10 years is integration of home healthcare and data collection. Many products are shifting to allow use through small home devices such as a smartphone or a tablet. Diagnostic or monitoring tests that have historically been conducted in a hospital or clinic are now completed within the comfort of home. Many of these devices are connected through the internet, and data can be uploaded to cloud storage for further review and analysis.
Cassano: Being able to reach out to product designers and manufacturers that might have the custom solution you are looking for is much easier now with the internet and search engines. Designers can connect with producers they might have never found previously.
Clippard: Essentially what this means is connectivity, down to the component level. What is the ability to reach out to a component buried inside a system and receive feedback? More connectivity and added features a device can offer in terms of communication and protocols can help read status and even determine life expectancy. There are many applications today where we are integrating technology on the development side so customers can have that functionality in the future where they don’t necessarily need it today. Whereas developing a device today that might not spark interest, in the future that same device in a lab or hospital could be utilized in ways the end-user is yet to realize the benefit.
The big challenge I see for the IoT is security. It exists on some level today with PCs, Teslas, and large PLC-controlled capital equipment—but when my microwave or fridge or medical gas regulator hiccups and the manufacturer can directly connect to it to evaluate the device and even service it, that’s cool. However, we all understand the risk with viruses, and a bigger challenge to remote IoT is having the right level of security and access through networks to be able to communicate with the device. For now, I see IoT being utilized in a discrete network for the benefit of accessing a device and information sharing from that device. Smart homes are great examples of the acceptance of accessible devices that share information. As I am writing this from the office, my home is reading 71°F. But if my home gets hacked, I’ll manage. Medical corporations have much more at stake and will need robust device security and network policies that bring engineers peace of mind.
Lassen: Robotic-assisted surgical (RAS) systems can be manipulated remotely, whether a few steps away or over much longer distances. Using low latency components are critical to simulating an in-person operation. As wearable and portable medical devices continue to rely more heavily on wireless connections, either through 5G cellular networks or Wi-Fi, most still require a power connection for charging.
Logsdon: We offer an RF wireless technology that operates in the 2.405 - 2.480 GHz frequency band, transmitting back and forth between the foot pedal and the receiver we provide. Safety protocol with the RF signal has to be in place to ensure there is no cross-talk between our foot pedal and any other wireless equipment in the OR.
Brusco: How are requests for low-power design impacting custom electronic component development?
Bratton: Low-power electronics include devices such as cardiac pacemakers, cardiac defibrillators, neurological stimulators, muscle stimulation devices, hearing aids, bone conduction amplifiers, tinnitus blockers, and cochlear implants. Plastics One has worked with OEM companies to help develop many of these solutions. We treat power requirements as an input to the overall project success and either verify or validate the performance criteria for each.
Cassano: Lower power componentry equals lower power consumption on an overall system. It pushes the manufacturers to design ever more efficient products based on customer power requirements or limitations.
Clippard: Whether an electronic vehicle or a cell phone, consumers don’t want to be recharging their devices too frequently—you want your product to go the distance. There is a unique balance in the design of these components between functionality and how much power will be consumed. A discrete component to perform a function that would be small and efficient versus larger, more robust, and powerful chips, boards, or circuits that can be utilized in a variety of applications. Regarding battery life, I see the lower powered design becoming less of an emphasis because of the advancements in battery technology.
Howard: Whether operating off a battery or not, power draw is always a vital design element and we are always asked about maximum current draw of our pumps. What we now offer customers is the ability to limit maximum current draw or program a slow start feature to reduce initial spikes of in-rush current, just with a simple custom parameter file uploaded to motor control boards set to whatever maximum current draw is requested. This is an especially nice feature when filters could clog and cause pressure build-up within a system. In this case, a pump would normally spike in power draw.
Lassen: Lower power designs typically mean smaller packages; however, with connectors there may be a need to keep a larger size for easier manipulation by hand. In this case, we can make the electrical contacts smaller while keeping the connector size the same, and the benefit is we can include more signal or power contacts.
Logsdon: Everything wireless seems to be moving toward the need for Bluetooth low energy (BLE) for medical devices. We have the capability to develop a BLE foot control to accommodate this type of request.
Brusco: Is the trend toward miniaturization of medical devices driving a need for flexible custom electronic components?
Bratton: Medical devices are constantly undergoing design changes and improvements to reduce size. As size reduces, many performance characteristics must be reviewed and tested before production implementation. Our pre-clinical division has been at the forefront of miniaturization working with university students and doctors on cannulas and electrodes used in drug delivery systems. We have also invested in tool-making technology to help facilitate mold fabrication on a miniature scale.
Cassano: Miniaturization itself is a custom solution, as it keeps evolving based on ever-changing needs to the application. As the requirements become more stringent, the product has to keep up with the requirements as well.
Clippard: The miniaturization of medical devices is astonishing considering the advancements in chip manufacturing—the size of what they can do on the tip of your pen versus even five years ago! Moore’s law states you can expect the capability of technology to double every few years. It’s exciting to see how much technology can be integrated into a pinhead. The miniaturization of medical devices brings new opportunities in having intelligence not just around your body, but in your body. Think about pacemakers and defibrillators that are now being embedded. Custom electronic components that will be robust, protected, and rated to be in the body is a fantastic advancement we are seeing today. The need to miniaturize those things and create components that have robust cycle lives and take care of life themselves is exciting to see.
Howard: As the overall envelope shrinks, the space available for subcomponents like pumps is reduced. We like to support these applications by increasing performance of our products electronically, rather than mechanically. Motor speeds can sometimes be slightly increased to hit performance points, while also offering the ability to monitor temperatures, should things heat up with less breathing room. We offer our engineering expertise and product flexibility to design the most efficient use of space within a given device.
Lassen: Miniaturization of a medical device can be accomplished by packaging elements that would normally be arrayed on the panel into a single connector. For instance, a single connector containing power contacts, data, high voltage for pulsed field ablation, and even fiber optics or fluidic/pneumatic contacts with automatic shutoffs can be combined into a single connector. This also simplifies the operation and setup of the equipment.
Logsdon: The goal lately in the foot switch world seems to be combining different functions into one foot control, which would eliminate the need for multiple foot controls on the floor taking up a bunch of space. This is truly a user preference as to how small they would want our pedal, but our ability to spin much smaller boards gives us the flexibility to create a smaller human interface.