Michael Barbella, Managing Editor04.12.21
Last spring, Vexos Inc. received a federal contract to produce 10,000 mechanical ventilators for COVID-19 patients in Canada. The global electronics manufacturing services (EMS) and custom material solutions provider was part of a consortium that worked to ensure the Land of Maple Syrup had a sufficient ventilator supply for its hospitalized patients.
Vexos worked with Elemaster Group and JMP Solutions to manufacture the Mechanical Ventilator Milano (MVM), an electrically operated, microprocessor-controlled, pneumatically driven machine. The project truly was a collaborative effort: Elemaster designed the ventilator, JPM Solutions made the mechanical sub-assembly, and Vexos provided the electronics (and tested the device).
“We recognized the need to partner with an experienced EMS organization with strong manufacturing and supply chain presence in the medical sector, and the ability to meet U.S. and Canadian regulatory requirements,” Elemaster President/CEO Gabriele Cogliati said. “In Vexos, we have a partner that aligns with us and our goal, to provide the MVM Ventilator globally.”
Such partnerships were commonplace in the pandemic’s early days as companies from all walks of life (including healthcare) turned to EMS providers for help in navigating COVID-19-induced supply chain challenges and equipment shortages. Their expertise particularly was crucial in maintaining device connectivity and meeting the skyrocketing demand for telehealth services and remote patient monitoring technology.
Medical Product Outsourcing’s January/February feature, Virtual Allies, examines the key role EMS providers played in helping address the medtech industry’s quickly-changing needs. Christian Fritz, sales director, Motion Control & Electronics, maxon group, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the latest trends in EMS outsourcing.
Christian Fritz: Many of the industry demands and trends over the past nine to 12 months have been overshadowed or amplified by the global COVID-19 pandemic and its ripple effects on the manufacturing industry and the medical device market. Medical device companies have seen massive swings in demand and the whole industry has been dealing with supply chain issues and an increased need to address fluctuating demand.
Besides the classical trends towards faster innovation, the need to meet tight time-to-market requirements and the necessity to provide cost-effective solutions, being able to quickly scale production up or down has been critical and has changed the relationship between the device builders and the EMS providers towards a much closer partnership.
Barbella: What are customers demanding of their EMS providers?
Fritz: Over the last couple of years, the medical device industry has been facing a changing landscape of regulatory requirements. This put strain on the design teams who had to build up knowledge and refine existing processes while executing a growing number of projects. To increase their engineering efficiency, many medical device companies turn to third parties and components vendors for some of the vertical expertise needed to complete their devices.
While the design needs to meet the technical requirements and provide the performance that the medical device requires, it is important to provide enough flexibility to allow for adjustments that might become necessary during prototyping stages or clinical trials. At the same time, it is important to consider the certification needs early on. Providers of custom electronics need to apply documented development processes and comprehensive test documentation that aids a smooth certification process.
Barbella: What qualities do OEMs look for in selecting EMS providers?
Fritz: It usually boils down to the value an EMS provider can offer to the OEM. While some start the search for an EMS with a very mature design and are mainly looking for a manufacturing partner that optimizes the solution for manufacturability, others are looking for a true design and manufacturing partner that can augment the design team with knowledge and expertise going far beyond manufacturing questions.
maxon , a key provider of small high-precision motors and motor control electronics, has increased its service offering over the last couple of years and is collaborating closely with medical device builders for their electronics needs. Leveraging the existing building blocks of off-the-shelf motor controllers, maxon can quickly provide a customized solution and help with the documentation needed for medical certifications. This makes maxon and ideal partner for medical device OEMs that require highly complex motion systems.
Barbella: How has IoT and IoMT influenced the kinds of products and technologies EMS providers have helped develop in recent years?
Fritz: There is an increased interest for leveraging IoT technologies (communication interfaces, security, increased data collection and analytics) that allow medical device builders to broaden their services offering, increase the uptime of their systems, and lowering the maintenance cost. This is especially true for devices that are targeted at medical service providers. When it comes to medical devices it is important to evaluate these technologies with a strong focus on security and data protection.
Barbella: How has the OEM-EMS provider relationship changed in the wake of COVID-19?
Fritz: The impact of COVID-19 on the manufacturing sector has been varied, but deep. Component shortages, shattered logistics chains, and fluctuating demand created challenges that no company could solve alone.
The collaboration between OEMs, EMS providers, raw material and components suppliers, and in some instances even end-customers (hospitals, government entities) was necessary to address the most critical needs and ensure the industry was able to overcome the disruption created by this unprecedented crisis. The companies that navigated this situation the best, were the ones that took swift action and pro-actively started an open communication with all the key stakeholders, including their respective design and manufacturing partners.
Barbella: What lessons - if any - have EMS providers learned from the pandemic that they can carry forward once the virus is brought under control?
Fritz: The renewed focus on establishing a closer collaboration and open communication will outlast the current crisis. Increased communication doesn’t just mean communicating more often, but also at different levels and including more of the job functions into the conversation.
Barbella: How were EMS providers’ supply chain management skills tested by the pandemic? How did your company respond to the challenge?
Fritz: As a global company we saw the challenges arise early on when lead times on raw material increased and the slowdown of international travel impacted some of the logistics routes. At that point maxon quickly established a cross functional team that proactively reached out to customers (medical OEM device builders) who provide critical equipment to the healthcare sector. We made sure to keep track of all of their needs and engaged them at different levels to see how we could best collaborate to overcome supply chain issues, streamline the logistics chain, and also engage the engineering teams if alternative solutions had to be evaluated. The lessons learned from these interactions were then applied to our broader customer base. We are continuing to learn from this situation and refining our strategy.
Vexos worked with Elemaster Group and JMP Solutions to manufacture the Mechanical Ventilator Milano (MVM), an electrically operated, microprocessor-controlled, pneumatically driven machine. The project truly was a collaborative effort: Elemaster designed the ventilator, JPM Solutions made the mechanical sub-assembly, and Vexos provided the electronics (and tested the device).
“We recognized the need to partner with an experienced EMS organization with strong manufacturing and supply chain presence in the medical sector, and the ability to meet U.S. and Canadian regulatory requirements,” Elemaster President/CEO Gabriele Cogliati said. “In Vexos, we have a partner that aligns with us and our goal, to provide the MVM Ventilator globally.”
Such partnerships were commonplace in the pandemic’s early days as companies from all walks of life (including healthcare) turned to EMS providers for help in navigating COVID-19-induced supply chain challenges and equipment shortages. Their expertise particularly was crucial in maintaining device connectivity and meeting the skyrocketing demand for telehealth services and remote patient monitoring technology.
Medical Product Outsourcing’s January/February feature, Virtual Allies, examines the key role EMS providers played in helping address the medtech industry’s quickly-changing needs. Christian Fritz, sales director, Motion Control & Electronics, maxon group, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the latest trends in EMS outsourcing.
Christian Fritz: Many of the industry demands and trends over the past nine to 12 months have been overshadowed or amplified by the global COVID-19 pandemic and its ripple effects on the manufacturing industry and the medical device market. Medical device companies have seen massive swings in demand and the whole industry has been dealing with supply chain issues and an increased need to address fluctuating demand.
Besides the classical trends towards faster innovation, the need to meet tight time-to-market requirements and the necessity to provide cost-effective solutions, being able to quickly scale production up or down has been critical and has changed the relationship between the device builders and the EMS providers towards a much closer partnership.
Barbella: What are customers demanding of their EMS providers?
Fritz: Over the last couple of years, the medical device industry has been facing a changing landscape of regulatory requirements. This put strain on the design teams who had to build up knowledge and refine existing processes while executing a growing number of projects. To increase their engineering efficiency, many medical device companies turn to third parties and components vendors for some of the vertical expertise needed to complete their devices.
While the design needs to meet the technical requirements and provide the performance that the medical device requires, it is important to provide enough flexibility to allow for adjustments that might become necessary during prototyping stages or clinical trials. At the same time, it is important to consider the certification needs early on. Providers of custom electronics need to apply documented development processes and comprehensive test documentation that aids a smooth certification process.
Barbella: What qualities do OEMs look for in selecting EMS providers?
Fritz: It usually boils down to the value an EMS provider can offer to the OEM. While some start the search for an EMS with a very mature design and are mainly looking for a manufacturing partner that optimizes the solution for manufacturability, others are looking for a true design and manufacturing partner that can augment the design team with knowledge and expertise going far beyond manufacturing questions.
maxon , a key provider of small high-precision motors and motor control electronics, has increased its service offering over the last couple of years and is collaborating closely with medical device builders for their electronics needs. Leveraging the existing building blocks of off-the-shelf motor controllers, maxon can quickly provide a customized solution and help with the documentation needed for medical certifications. This makes maxon and ideal partner for medical device OEMs that require highly complex motion systems.
Barbella: How has IoT and IoMT influenced the kinds of products and technologies EMS providers have helped develop in recent years?
Fritz: There is an increased interest for leveraging IoT technologies (communication interfaces, security, increased data collection and analytics) that allow medical device builders to broaden their services offering, increase the uptime of their systems, and lowering the maintenance cost. This is especially true for devices that are targeted at medical service providers. When it comes to medical devices it is important to evaluate these technologies with a strong focus on security and data protection.
Barbella: How has the OEM-EMS provider relationship changed in the wake of COVID-19?
Fritz: The impact of COVID-19 on the manufacturing sector has been varied, but deep. Component shortages, shattered logistics chains, and fluctuating demand created challenges that no company could solve alone.
The collaboration between OEMs, EMS providers, raw material and components suppliers, and in some instances even end-customers (hospitals, government entities) was necessary to address the most critical needs and ensure the industry was able to overcome the disruption created by this unprecedented crisis. The companies that navigated this situation the best, were the ones that took swift action and pro-actively started an open communication with all the key stakeholders, including their respective design and manufacturing partners.
Barbella: What lessons - if any - have EMS providers learned from the pandemic that they can carry forward once the virus is brought under control?
Fritz: The renewed focus on establishing a closer collaboration and open communication will outlast the current crisis. Increased communication doesn’t just mean communicating more often, but also at different levels and including more of the job functions into the conversation.
Barbella: How were EMS providers’ supply chain management skills tested by the pandemic? How did your company respond to the challenge?
Fritz: As a global company we saw the challenges arise early on when lead times on raw material increased and the slowdown of international travel impacted some of the logistics routes. At that point maxon quickly established a cross functional team that proactively reached out to customers (medical OEM device builders) who provide critical equipment to the healthcare sector. We made sure to keep track of all of their needs and engaged them at different levels to see how we could best collaborate to overcome supply chain issues, streamline the logistics chain, and also engage the engineering teams if alternative solutions had to be evaluated. The lessons learned from these interactions were then applied to our broader customer base. We are continuing to learn from this situation and refining our strategy.
