Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

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. Steven Lassen, senior customer application engineer at LEMO USA Inc., was among the experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: How has IoT and IoMT influenced the kinds of products and technologies EMS providers have helped develop in recent years?
Steven Lassen: Higher speed data for communication and especially high resolution 4K video requires the use of impedance-matched connectors that are ruggedized to withstand the operating room environment and various harsh sterilization methods including steam autoclave. In some applications fiber optics is being integrated into the systems and these also need to be rugged. Fiber optics introduces a new element of cleanliness as the end faces of the fiber contacts need to be cleaned before each use. This is done by including a cleaning tool with the equipment, and training of the operators.
 
Barbella: Please discuss the biggest challenges EMS providers face regarding technology in the next 5 years. How is your company addressing these challenges?
Lassen: Government restrictions phasing in regulations such as BPA-free, lead-free, Reach, RoHS, and in California Proposition 65, limit the types of materials used in the assemblies. LEMO offers products that comply with the BPA-free and RoHS requirements. We continually evaluate and test new materials, offering them as standard product instead of special order.
 
Barbella: There has been a big push in many areas of healthcare for environmentally-friendly (“green”) manufacturing and products. Is this also true in the EMS space? If so, how are EMS providers helping customers be more green in their product development and/or manufacturing?
Lassen: Packaging materials used to ship product are being evaluated. For disposable products, OEMs are questioning if the disposed product can be recycled in any way; i.e. gold removed from contacts, or plastics being ground so they can be re-used.
Consolidating shipments as much as possible. LEMO is a Sony Green Partner for environmental quality approval program for the broadcast industry. Since 2005 LEMO has been awarded by SONY the Green Partner Certificate and we are committed to a continuous cooperation on Sony environmental quality assurance activities. 
 
Barbella: How has the OEM-EMS provider relationship changed in the wake of COVID-19?
Lassen: FDA waivers for product substitution in a streamlined communication path has been able to expedite product delivery, especially for applications that involve respirator equipment.
 
Barbella: How were EMS providers’ supply chain management skills tested by the pandemic? How did your company respond to the challenge?
Lassen: LEMO is a preferred partner in the medical sector due to the ruggedness, reliability, and ease of use of its solutions. Today, we supply most major medical technology companies, including ventilators. 
Like other key medical suppliers LEMO committed to the global battle against the COVID-19, our role has been acknowledged by the government of the Swiss Canton of Vaud (where Ecublens is located) and received the authorization to continue working even throughout the pandemic. The applications of our solutions in respiratory assistance equipment are varied: for Chinese, English, Swiss and U.S. devices, the LEMO Group’s products connect sensor systems to measure and regulate CO₂, temperature, or humidity; for a Canadian manufacturer they are for sensors monitoring the patient’s vital signs; for Swiss manufacturers they are for floating rotor systems or screen systems.
Other medical technologies central to the functioning of hospital emergency or intensive care units also use LEMO connectors, e.g., in patient monitoring (sensors measuring the level of O₂), infusion administration, blood testing and cardiac resuscitation. There are also LEMO connectors in the automatic body temperature measuring systems in public spaces.