Mark Crawford, Contributing Writer02.07.12
With increased overall accountability and supply chain management required of medical device manufacturers by the U.S. Food and Drug Administration (FDA), combined with increasing complexity and miniaturization of devices, a growing number OEMs are outsourcing electronic manufacturing services (EMS) to providers with an ever-growing stable of capabilities—both here at home and abroad, depending upon customer need. This decision allows OEMs to focus more on their core strengths, counting on their EMS partners to be their expert guides regarding compliance and technology while, of course, delivering better price points and sharing the risk of deeper involvement.
“Some OEMs are bringing programs back from low-cost manufacturing sites,” said Jeffrey Ocker, director of manufacturing for Burton Industries Inc., a Hazelhurst, Wis.-based custom manufacturer that provides EMS services to medical OEMs. “In some cases, lower-volume programs were not good candidates to begin with for offshore and the delivery/quality issues were just becoming too painful for OEMs to leave offshore.”
In the move to save costs, some companies failed to take into account some of the unforeseen costs of offshore manufacturing.
“I think companies are taking a closer look at all the soft costs involved in maintaining a relationship with overseas manufacturing suppliers, not to mention the effects of the natural disasters in the Far East regions,” said Tanya Martin, sales manager for Versa Electronics in Minneapolis, Minn., a provider of printed circuit board (PCB) assembly and device build for the medical industry.
Coming back home and/or outsourcing to domestic EMS providers are decisions driven by the need to maintain quality, which is more difficult to do in overseas operations, especially with smaller and more complex devices, experts noted. This is an increasing trend as OEMs continue to develop easy-to-use home healthcare devices that are affordable, accurate, smaller, higher performance and deliver the functionality and dependability that end-users require.
A big reason OEMs are targeting home health equipment is that it is a hot market—currently valued at about $32 billion and projected to top $45 billion by 2017; GBI Research forecasts the market will grow about 6 percent per year within the next five years.
“Medical design manufacturers are responding to demands for smaller, more durable devices with more innovative features, faster transmission of critical data and a higher degree of protective shielding,” said Steve Sheehan, director of medical business development for Hypertronics Corp., a Hudson, Mass.-based supplier of high-performance electrical/electronic connectors and cabling for the medical industry. “Keeping pace with the new technological demands of the medical device industry can be challenging for EMS providers.”
Delivering More Value
If an EMS company wants to stay in an OEM’s supply chain as a preferred provider, it must be nimble and multi-faceted. It must have the ability to deliver all the products, services and materials customers want, quickly and at low cost. As OEMs are challenged to do more with less, EMS providers must also deliver more value to the outsourcing equation.
“EMS companies are seeing OEMs place greater value on their expertise in electronics,” said Alan Myers, vice president for global business units, healthcare and life sciences for Jabil Circuit Inc., an electronics design and manufacturing company in St. Petersburg, Fla. “As medical equipment and devices become more technologically complex and OEMs face higher costs and delays in implementing these new capabilities, an EMS partner’s knowledge, skills and ongoing work with the latest electronics technologies can be tremendous assets.”
In addition to delivering traditional cost advantages, EMS providers offer core competencies in the ever-smaller and more-sophisticated electronics needed to support trends toward miniaturization, non-surgical/minimally invasive surgical devices and home healthcare delivery—all rapidly growing markets. For many OEMs, these capabilities are outside their area of expertise.
“We aren’t simply building product,” noted Wally Johnson, vice president of sales and marketing for Spectrum Assembly Inc., a Carlsbad, Calif.-based EMS company. “We also provide manufacturability expertise, supply chain management and a disciplined product realization process. There was a time when those capabilities predominately applied to Tier-1 EMS companies. It was expected that regional EMS providers like us were more limited in capabilities and expertise. Today, however, customers expect that level of service and expertise from every EMS provider, regardless of size. We’ve spent significant time analyzing our processes and systems to ensure that we bring that level of capability and expertise in our relationships.”
It’s not just the technical knowhow OEMs are looking for—they want their EMS vendors to handle supply chain duties including bill of material (BOM) analysis and feedback to prospects/customers on items such as component life cycle, restriction of the use of certain hazardous substances (RoHS) compliance, suitable alternates, etc. Customer expectations also are higher for assistance with designs for manufacturability, testing, quality and cost. Customer-specific functional testing to accommodate box build capability is another growing demand, which sometimes require long test cycles with temperature ramp requirements.
“We also provide component life cycle analysis and design for manufacturing (DFM) reviews,” said Ocker.“Both these items are huge value-adds to our customers.Performing these up front can greatly reduce the amount of down time because of component availability issues or struggles on the line.”
If an EMS company does not provide all the services an OEM wants, it will quickly find itself out of the game. It must expand its capabilities by investing in more space, equipment, technology and materials (inventory). One way to do this is through vertical integration, which cuts the number of suppliers, reducing transaction costs and the resources needed to manage higher numbers of suppliers. Vertical integration is a competitive advantage (particularly with configure-to-order products or those with variable demand patterns). In the medical industry, the ability to one-stop-shop also reduces the audit/oversight costs that come with highly regulated environments.
Schedule flexibility also is a factor.
“At least one of our medical customers finds a vertically integrated local solution for cables, printed circuit board assembly and system integration preferable to sourcing offshore when they add up project requirements and total cost,” said Johnson.
Virtual integration, or the ability of teams of companies to work together closely, also is growing in popularity.
“Fortunately, the cost of systems that facilitate that type of shared information environment is dropping rapidly and systems that used to require significant data manipulation to communicate with other systems now work in a Windows environment,” added Johnson.
Like many companies in this space, Spectrum Assembly has migrated to paperless systems wherever possible. Enterprise resource planning (ERP), production documentation and quality systems all are paperless throughout the company. Production operators use documentation displayed on touch screens instead of paper documentation.
“This provides better traceability, faster product changeovers and better configuration management,” said Johnson. “It also helps reduce traceability and recordkeeping costs.”
A lower-cost alternative to vertical integration is joining strategic alliances that expand services.
“Customers want full service, even from smaller EMS providers, and strategic alliances help deliver this without increasing cost,” indicated Susan Mucha, president of Powell-Mucha Consulting Inc. in El Paso, Texas.
This is especially useful for services that a company wants to provide but for which there is limited demand.
“A good example would be PCB layout,” Johnson told Medical Product Outsourcing. “At this point, for Spectrum Assembly, it is more cost effective to buy that service outside. However, if demand increased we would hire a designer.”
Burton Industries founded and uses a supplier alliance group known as the Worldclass Industrial Network (WIN) Alliance.
“Our clients were looking for lower costs, greater schedule flexibility and shorter lead times,” said Ocker. “We were concerned about lack of demand predictability combined with stocking too much inventory. The WIN Alliance grew out of the realization that a growing number of projects would be best served by a one-stop shop, capable of full service support beyond the services that any one of its members was able to provide alone.”
The trick to making this kind of alliance work is that every member must be absolutely committed and responsive to the mission of working together in a lean, expeditious way to assist each other’s projects.
For the WIN Alliance, every supplier is aware of the need for a level of coordination that appears seamless to the customer. As a result, the alliance developed very specific criteria for all its supplier members, including a strong ability to support new product introduction, scale production resources with project growth and, in some cases, support offshore production in higher volumes.
“Right now our partners include a tooling and plastics injection molding firm with both U.S. and Asia manufacturing capabilities, Asian and U.S. printed circuit board fabricators, a liquid crystal display manufacturer, two Asian EMS suppliers for higher-volume projects, product design firms, a manufacturer of soft-sided cases and a conformal coating supplier,” Ocker continued. “Sources for potting and metal fabrication, as well as Asian sources for transformers and other price sensitive components, are in the identification and evaluation stage.”
Technology Trends
Technological advances continue to be made in printed electronics, flexible circuits, X-ray designs and testing equipment. Continued miniaturization of electronic components also is opening new design possibilities for medical drug delivery devices. With flexible circuits, chip on flex circuits and reduction in the size of memory, microprocessors and passive components, it now is possible to integrate electronics for data collection and communication into smaller handheld drug delivery devices.
Miniaturization is a continuing trend—this drives needs for surface mount technology (SMT) placement machines with vision capable of placing components down to .01-.005 inches and automated optical inspection machines capable of ensuring the quality of the placement and soldering process.
“With these smaller footprint components,” said Johnson, “placement machines are required to have repeatability to 75/1,000 of a millimeter and accuracy to 95/1,000 of a millimeter.As the component becomes smaller, the need for high magnification, multi-camera automated vision systems are needed to aid with process verification. There are also better tools to support the requirements of high product mix environments requiring quick changeover time. For example, point-of-use stocking is a basic Lean principle that speeds changeovers and improves throughput. However, point-of-use stocking can create quality or inventory reconciliation issues if components aren’t handled properly. We use line-side component towers that provide a humidity-controlled environment and link to our ERP system. Competitively priced options for doing this didn’t exist a few years ago.”
The demands for smaller, enhanced products with higher levels of performance continue to challenge EMS providers.
“Connectors, for example, must be smaller, but still function at same high level as larger connectors had done,” said Sheehan.“At this more challenging scale, interconnectors must ensure high mating cycles, low contact resistance, signal integrity and protection for sensitive medical device circuitry from damaging EMI (electromagnetic interference) and RFI (radio frequency interference).”
Wireless technologies that power consumer electronic devices also are being tapped as the connection between in-home medical devices and staff or databases in hospitals and doctors’ offices. Wireless-enabled drug delivery devices offer patients the convenience of using familiar phones and tablets to transmit medical information remotely.
“We get many inquiries about incorporating wireless into medical products,” commented Joe Horvath, president and CEO of Sanbor Medical Corp., a contract manufacturer and EMS provider for the medical industry based in Allentown, Pa. “There is strong interest in the home healthcare market, especially for self-monitoring and follow-up therapies. Wireless products can share data in real time with physicians and clinicians.”
Wireless devices also address critical issues such as cost escalation, provider shortages, population management and proliferation of chronic conditions that are in the forefront of the healthcare reform movement.
“For example,” said Jabil Circuit’s Myers, “dosage, time of dosing and compliance with a medication schedule can be logged and communicated to the prescribing physician to monitor a patient’s status, reducing the need for costly office visits and optimizing provider time while increasing quality of care. Additionally, very precise electronics and computerized calculations can increase accuracy of delivery compared to a patient’s ‘mechanical’ delivery, such as alignment with a printed mark on a syringe, vial or device, also helping to raise quality. Data sent via wireless communication can help to build patient registries needed for management of populations with chronic diseases.”
As of yet, the FDA and Federal Communications Commission have not dedicated a frequency band for wireless medical devices. One set of frequencies in particular—ultrawideband (UWB; 3.1 to 10.6 GHz)—has great potential for medical devices but is not well understood within the industry.
Ultrawideband radios can be high-speed, highly energy-efficient radios that are characterized by short range (typically 3 meters to as much as 13 meters).
“Short-range, high-speed cable replacement applications make ultrawideband radios ideal candidates for a variety of wireless medical applications,” said Eric Broockman, CEO of Alereon Inc., a semiconductor company in Austin, Texas, that develops UWB wireless chipsets. These applications include cart-based equipment that often is used at the bedside or in an operating theater, where a cable connection would limit portability and frequent movement.
Broockman said that within the medical industry GE Healthcare uses UWB frequencies with a mobile X-ray system, and NDS Surgical Imaging LLC also has developed a wireless video product for use in operating room theaters for connecting video cameras to large screen displays.
Power consumption issues are a big challenge for wireless medical devices and tend to limit architectural design and the type of application. However, Bluetooth low-energy technology could be a big boost for wireless medical products because it’s specifically designed for ultra-low-power batteries and a new sensor-based data collection framework. With this kind of potential, Bluetooth low-energy technology likely will become part of many handheld products, including medical devices.
In another demonstration of innovative wireless medical applications, last year Ford Motor Company researchers demonstrated a series of in-car health and wellness connectivity services and applications designed to help people monitor and manage chronic illnesses or medical disorders such as diabetes, asthma or allergies while they are on the road. Such wireless applications enable, for example, glucose device connectivity and monitoring capability, as well as real-time, location-based allergy and pollen reports.
The data then can be transmitted via Bluetooth, cloud-based Internet services or smartphone applications. Ford has worked closely with Medtronic Inc. to develop a prototype system that transmits glucose monitoring data through audio and a center stack display, as well as provide secondary alerts if glucose levels are too low.
Outsourcing for the First Time
Large medical OEMs continue to acquire smaller companies. Sometimes these companies haven’t outsourced, preferring to manufacture in-house. If the acquiring OEM feels that outsourcing is a better way to go than in-house manufacturing, it directs the acquired company to shut down all or part of manufacturing and outsource that requirement.
“Companies that have never outsourced before might not have all their processes well enough documented to give to a third party,” said Mucha. “Some contractors have special teams that analyze what needs to be done to ensure smooth transitions and help that company get everything organized.
Even when an acquisition isn’t involved, companies new to outsourcing frequently need more support than companies that outsource regularly.”
One of the biggest issues for companies new to outsourcing is that they may not understand exactly what the EMS provider needs in terms of documentation.
“Just like any product transfer, a good ‘knowledge dump’ is essential,” said Ocker.“Tribal knowledge is part of any organization and making sure that knowledge is transposed into formal documentation or done via the production start-up process can be challenging. The documentation is generally not robust or up to the standards to easily incorporate into the contract manufacturer’s requirements and preferred formats. Excess material can also be an issue because customers new to sourcing generally do a poor job of managing material and expect the contractor to take all inventory as part of acceptance of the program.”
Spectrum Assembly developed a service package specifically to address this challenge. Its “Tiger Team” includes engineers, a buyer/planner and program manager who assess potential issues and develop documentation and processes in cases where a customer’s tribal knowledge isn’t well documented. They especially review the materials portion of the equation.
“We need to determine what is actually active inventory and help them develop an efficient forecast methodology,” said Johnson. “We also look at the condition of the inventory. Has it been stored properly? Could age be impacting quality? We take over the existing inventory that is usable and transition the ordering process to our team. We also analyze their existing processes and designs formanufacturability and quality issues. By providing the customer with a project launch checklist and specific recommendations to address any issues the Tiger Team identifies, we have a clear roadmap for next steps.”
Burton Industries’ preferred approach relative to OEM-supplied material is to accept material from the customer to be placed in a “customer supplied location” for future consumption on program.
“This assumes the customer has done a good job of counting components and package requirements (tape/reel, matrix tray, etc. versus loose components) for introduction to placement equipment,” added Ocker.
Johnson warned that customers new to outsourcing can underestimate the time needed to transfer production.
“Particularly, with medical products, material can’t simply be moved one day and production begin the next,” he said. “Systems must be set up that can provide adequate traceability and processes and product must go through a qualification phase.”
While system setup is not time consuming or costly, the process of programming equipment, ordering custom production tooling, developing work instructions and uploading project information into the ERP system can take anywhere from a few days to a few weeks, depending on project complexity, production equipment similarities and level of existing electronic documentation.
“However,” said Johnson, “when a company has been building stable product lines for several years, it can forget the front-end activity that preceded production start or assume that it isn’t necessary when production is transferred.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.
“Some OEMs are bringing programs back from low-cost manufacturing sites,” said Jeffrey Ocker, director of manufacturing for Burton Industries Inc., a Hazelhurst, Wis.-based custom manufacturer that provides EMS services to medical OEMs. “In some cases, lower-volume programs were not good candidates to begin with for offshore and the delivery/quality issues were just becoming too painful for OEMs to leave offshore.”
In the move to save costs, some companies failed to take into account some of the unforeseen costs of offshore manufacturing.
“I think companies are taking a closer look at all the soft costs involved in maintaining a relationship with overseas manufacturing suppliers, not to mention the effects of the natural disasters in the Far East regions,” said Tanya Martin, sales manager for Versa Electronics in Minneapolis, Minn., a provider of printed circuit board (PCB) assembly and device build for the medical industry.
An engineer at Burton Industries Inc. analyzes bill of material component obsolescence risk using lifecycle analysis software. Tools such as this help identify potential obsolescence issues early. Photo courtesy of Burton Industries Inc. |
Coming back home and/or outsourcing to domestic EMS providers are decisions driven by the need to maintain quality, which is more difficult to do in overseas operations, especially with smaller and more complex devices, experts noted. This is an increasing trend as OEMs continue to develop easy-to-use home healthcare devices that are affordable, accurate, smaller, higher performance and deliver the functionality and dependability that end-users require.
A big reason OEMs are targeting home health equipment is that it is a hot market—currently valued at about $32 billion and projected to top $45 billion by 2017; GBI Research forecasts the market will grow about 6 percent per year within the next five years.
“Medical design manufacturers are responding to demands for smaller, more durable devices with more innovative features, faster transmission of critical data and a higher degree of protective shielding,” said Steve Sheehan, director of medical business development for Hypertronics Corp., a Hudson, Mass.-based supplier of high-performance electrical/electronic connectors and cabling for the medical industry. “Keeping pace with the new technological demands of the medical device industry can be challenging for EMS providers.”
Delivering More Value
If an EMS company wants to stay in an OEM’s supply chain as a preferred provider, it must be nimble and multi-faceted. It must have the ability to deliver all the products, services and materials customers want, quickly and at low cost. As OEMs are challenged to do more with less, EMS providers must also deliver more value to the outsourcing equation.
“EMS companies are seeing OEMs place greater value on their expertise in electronics,” said Alan Myers, vice president for global business units, healthcare and life sciences for Jabil Circuit Inc., an electronics design and manufacturing company in St. Petersburg, Fla. “As medical equipment and devices become more technologically complex and OEMs face higher costs and delays in implementing these new capabilities, an EMS partner’s knowledge, skills and ongoing work with the latest electronics technologies can be tremendous assets.”
In addition to delivering traditional cost advantages, EMS providers offer core competencies in the ever-smaller and more-sophisticated electronics needed to support trends toward miniaturization, non-surgical/minimally invasive surgical devices and home healthcare delivery—all rapidly growing markets. For many OEMs, these capabilities are outside their area of expertise.
“We aren’t simply building product,” noted Wally Johnson, vice president of sales and marketing for Spectrum Assembly Inc., a Carlsbad, Calif.-based EMS company. “We also provide manufacturability expertise, supply chain management and a disciplined product realization process. There was a time when those capabilities predominately applied to Tier-1 EMS companies. It was expected that regional EMS providers like us were more limited in capabilities and expertise. Today, however, customers expect that level of service and expertise from every EMS provider, regardless of size. We’ve spent significant time analyzing our processes and systems to ensure that we bring that level of capability and expertise in our relationships.”
It’s not just the technical knowhow OEMs are looking for—they want their EMS vendors to handle supply chain duties including bill of material (BOM) analysis and feedback to prospects/customers on items such as component life cycle, restriction of the use of certain hazardous substances (RoHS) compliance, suitable alternates, etc. Customer expectations also are higher for assistance with designs for manufacturability, testing, quality and cost. Customer-specific functional testing to accommodate box build capability is another growing demand, which sometimes require long test cycles with temperature ramp requirements.
“We also provide component life cycle analysis and design for manufacturing (DFM) reviews,” said Ocker.“Both these items are huge value-adds to our customers.Performing these up front can greatly reduce the amount of down time because of component availability issues or struggles on the line.”
If an EMS company does not provide all the services an OEM wants, it will quickly find itself out of the game. It must expand its capabilities by investing in more space, equipment, technology and materials (inventory). One way to do this is through vertical integration, which cuts the number of suppliers, reducing transaction costs and the resources needed to manage higher numbers of suppliers. Vertical integration is a competitive advantage (particularly with configure-to-order products or those with variable demand patterns). In the medical industry, the ability to one-stop-shop also reduces the audit/oversight costs that come with highly regulated environments.
Schedule flexibility also is a factor.
“At least one of our medical customers finds a vertically integrated local solution for cables, printed circuit board assembly and system integration preferable to sourcing offshore when they add up project requirements and total cost,” said Johnson.
Virtual integration, or the ability of teams of companies to work together closely, also is growing in popularity.
“Fortunately, the cost of systems that facilitate that type of shared information environment is dropping rapidly and systems that used to require significant data manipulation to communicate with other systems now work in a Windows environment,” added Johnson.
Like many companies in this space, Spectrum Assembly has migrated to paperless systems wherever possible. Enterprise resource planning (ERP), production documentation and quality systems all are paperless throughout the company. Production operators use documentation displayed on touch screens instead of paper documentation.
“This provides better traceability, faster product changeovers and better configuration management,” said Johnson. “It also helps reduce traceability and recordkeeping costs.”
A lower-cost alternative to vertical integration is joining strategic alliances that expand services.
“Customers want full service, even from smaller EMS providers, and strategic alliances help deliver this without increasing cost,” indicated Susan Mucha, president of Powell-Mucha Consulting Inc. in El Paso, Texas.
This is especially useful for services that a company wants to provide but for which there is limited demand.
“A good example would be PCB layout,” Johnson told Medical Product Outsourcing. “At this point, for Spectrum Assembly, it is more cost effective to buy that service outside. However, if demand increased we would hire a designer.”
Burton Industries founded and uses a supplier alliance group known as the Worldclass Industrial Network (WIN) Alliance.
“Our clients were looking for lower costs, greater schedule flexibility and shorter lead times,” said Ocker. “We were concerned about lack of demand predictability combined with stocking too much inventory. The WIN Alliance grew out of the realization that a growing number of projects would be best served by a one-stop shop, capable of full service support beyond the services that any one of its members was able to provide alone.”
The trick to making this kind of alliance work is that every member must be absolutely committed and responsive to the mission of working together in a lean, expeditious way to assist each other’s projects.
For the WIN Alliance, every supplier is aware of the need for a level of coordination that appears seamless to the customer. As a result, the alliance developed very specific criteria for all its supplier members, including a strong ability to support new product introduction, scale production resources with project growth and, in some cases, support offshore production in higher volumes.
“Right now our partners include a tooling and plastics injection molding firm with both U.S. and Asia manufacturing capabilities, Asian and U.S. printed circuit board fabricators, a liquid crystal display manufacturer, two Asian EMS suppliers for higher-volume projects, product design firms, a manufacturer of soft-sided cases and a conformal coating supplier,” Ocker continued. “Sources for potting and metal fabrication, as well as Asian sources for transformers and other price sensitive components, are in the identification and evaluation stage.”
Technology Trends
Technological advances continue to be made in printed electronics, flexible circuits, X-ray designs and testing equipment. Continued miniaturization of electronic components also is opening new design possibilities for medical drug delivery devices. With flexible circuits, chip on flex circuits and reduction in the size of memory, microprocessors and passive components, it now is possible to integrate electronics for data collection and communication into smaller handheld drug delivery devices.
Miniaturization is a continuing trend—this drives needs for surface mount technology (SMT) placement machines with vision capable of placing components down to .01-.005 inches and automated optical inspection machines capable of ensuring the quality of the placement and soldering process.
“With these smaller footprint components,” said Johnson, “placement machines are required to have repeatability to 75/1,000 of a millimeter and accuracy to 95/1,000 of a millimeter.As the component becomes smaller, the need for high magnification, multi-camera automated vision systems are needed to aid with process verification. There are also better tools to support the requirements of high product mix environments requiring quick changeover time. For example, point-of-use stocking is a basic Lean principle that speeds changeovers and improves throughput. However, point-of-use stocking can create quality or inventory reconciliation issues if components aren’t handled properly. We use line-side component towers that provide a humidity-controlled environment and link to our ERP system. Competitively priced options for doing this didn’t exist a few years ago.”
The demands for smaller, enhanced products with higher levels of performance continue to challenge EMS providers.
“Connectors, for example, must be smaller, but still function at same high level as larger connectors had done,” said Sheehan.“At this more challenging scale, interconnectors must ensure high mating cycles, low contact resistance, signal integrity and protection for sensitive medical device circuitry from damaging EMI (electromagnetic interference) and RFI (radio frequency interference).”
Wireless technologies that power consumer electronic devices also are being tapped as the connection between in-home medical devices and staff or databases in hospitals and doctors’ offices. Wireless-enabled drug delivery devices offer patients the convenience of using familiar phones and tablets to transmit medical information remotely.
“We get many inquiries about incorporating wireless into medical products,” commented Joe Horvath, president and CEO of Sanbor Medical Corp., a contract manufacturer and EMS provider for the medical industry based in Allentown, Pa. “There is strong interest in the home healthcare market, especially for self-monitoring and follow-up therapies. Wireless products can share data in real time with physicians and clinicians.”
Wireless devices also address critical issues such as cost escalation, provider shortages, population management and proliferation of chronic conditions that are in the forefront of the healthcare reform movement.
“For example,” said Jabil Circuit’s Myers, “dosage, time of dosing and compliance with a medication schedule can be logged and communicated to the prescribing physician to monitor a patient’s status, reducing the need for costly office visits and optimizing provider time while increasing quality of care. Additionally, very precise electronics and computerized calculations can increase accuracy of delivery compared to a patient’s ‘mechanical’ delivery, such as alignment with a printed mark on a syringe, vial or device, also helping to raise quality. Data sent via wireless communication can help to build patient registries needed for management of populations with chronic diseases.”
As of yet, the FDA and Federal Communications Commission have not dedicated a frequency band for wireless medical devices. One set of frequencies in particular—ultrawideband (UWB; 3.1 to 10.6 GHz)—has great potential for medical devices but is not well understood within the industry.
Ultrawideband radios can be high-speed, highly energy-efficient radios that are characterized by short range (typically 3 meters to as much as 13 meters).
“Short-range, high-speed cable replacement applications make ultrawideband radios ideal candidates for a variety of wireless medical applications,” said Eric Broockman, CEO of Alereon Inc., a semiconductor company in Austin, Texas, that develops UWB wireless chipsets. These applications include cart-based equipment that often is used at the bedside or in an operating theater, where a cable connection would limit portability and frequent movement.
Broockman said that within the medical industry GE Healthcare uses UWB frequencies with a mobile X-ray system, and NDS Surgical Imaging LLC also has developed a wireless video product for use in operating room theaters for connecting video cameras to large screen displays.
Power consumption issues are a big challenge for wireless medical devices and tend to limit architectural design and the type of application. However, Bluetooth low-energy technology could be a big boost for wireless medical products because it’s specifically designed for ultra-low-power batteries and a new sensor-based data collection framework. With this kind of potential, Bluetooth low-energy technology likely will become part of many handheld products, including medical devices.
In another demonstration of innovative wireless medical applications, last year Ford Motor Company researchers demonstrated a series of in-car health and wellness connectivity services and applications designed to help people monitor and manage chronic illnesses or medical disorders such as diabetes, asthma or allergies while they are on the road. Such wireless applications enable, for example, glucose device connectivity and monitoring capability, as well as real-time, location-based allergy and pollen reports.
The data then can be transmitted via Bluetooth, cloud-based Internet services or smartphone applications. Ford has worked closely with Medtronic Inc. to develop a prototype system that transmits glucose monitoring data through audio and a center stack display, as well as provide secondary alerts if glucose levels are too low.
Outsourcing for the First Time
Large medical OEMs continue to acquire smaller companies. Sometimes these companies haven’t outsourced, preferring to manufacture in-house. If the acquiring OEM feels that outsourcing is a better way to go than in-house manufacturing, it directs the acquired company to shut down all or part of manufacturing and outsource that requirement.
“Companies that have never outsourced before might not have all their processes well enough documented to give to a third party,” said Mucha. “Some contractors have special teams that analyze what needs to be done to ensure smooth transitions and help that company get everything organized.
Even when an acquisition isn’t involved, companies new to outsourcing frequently need more support than companies that outsource regularly.”
One of the biggest issues for companies new to outsourcing is that they may not understand exactly what the EMS provider needs in terms of documentation.
“Just like any product transfer, a good ‘knowledge dump’ is essential,” said Ocker.“Tribal knowledge is part of any organization and making sure that knowledge is transposed into formal documentation or done via the production start-up process can be challenging. The documentation is generally not robust or up to the standards to easily incorporate into the contract manufacturer’s requirements and preferred formats. Excess material can also be an issue because customers new to sourcing generally do a poor job of managing material and expect the contractor to take all inventory as part of acceptance of the program.”
Spectrum Assembly developed a service package specifically to address this challenge. Its “Tiger Team” includes engineers, a buyer/planner and program manager who assess potential issues and develop documentation and processes in cases where a customer’s tribal knowledge isn’t well documented. They especially review the materials portion of the equation.
“We need to determine what is actually active inventory and help them develop an efficient forecast methodology,” said Johnson. “We also look at the condition of the inventory. Has it been stored properly? Could age be impacting quality? We take over the existing inventory that is usable and transition the ordering process to our team. We also analyze their existing processes and designs formanufacturability and quality issues. By providing the customer with a project launch checklist and specific recommendations to address any issues the Tiger Team identifies, we have a clear roadmap for next steps.”
Burton Industries’ preferred approach relative to OEM-supplied material is to accept material from the customer to be placed in a “customer supplied location” for future consumption on program.
“This assumes the customer has done a good job of counting components and package requirements (tape/reel, matrix tray, etc. versus loose components) for introduction to placement equipment,” added Ocker.
Johnson warned that customers new to outsourcing can underestimate the time needed to transfer production.
“Particularly, with medical products, material can’t simply be moved one day and production begin the next,” he said. “Systems must be set up that can provide adequate traceability and processes and product must go through a qualification phase.”
While system setup is not time consuming or costly, the process of programming equipment, ordering custom production tooling, developing work instructions and uploading project information into the ERP system can take anywhere from a few days to a few weeks, depending on project complexity, production equipment similarities and level of existing electronic documentation.
“However,” said Johnson, “when a company has been building stable product lines for several years, it can forget the front-end activity that preceded production start or assume that it isn’t necessary when production is transferred.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.