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Industry Takes Pulse on Lead-free Medical Electronics
December 31, 1969 |Estimated reading time: 5 minutes
By Meredith Courtemanche, assistant editor
As exemptions to the EU RoHS approach expiration, and China RoHS legislation is set to take effect in March with no exemptions offered for high-reliability electronics, the electronics assembly industry is taking measures to ensure that lead-free medical equipment meets reliability, cost, and market requirements. The responsibilities of OEMs and design firms, suppliers, and EMS providers vary, but all revolve around bringing a product to market that suffers no performance or life-cycle flaws due to compliance with environmental legislation.
Medical electronics bring a host of concerns that other sectors do not. Some devices are implanted in the human body, making maintenance and repair on the end-product exponentially more difficult and expensive. The FDA must approve new designs, extending time-to-market by six months to a year, sometimes more. Recommendations to the EU from ERA Technologies suggest that exemptions 8 and 9 for medical equipment should expire between 2012 for some machinery, and 2020 for active implanted devices (some push for permanent exemption in this product group), according to Natalie McKinsey, global environmental manager at Solectron. Critical equipment such as in-vitro diagnostic (IVD) instruments should be lead-free by 2016, so product designs and tests should be carried out well in advance. OEMs converting an existing product to lead-free still may need to submit this device to the appropriate government bodies for reapproval, because converting to lead-free can alter a design, bill of materials (BOM), and a product's lifecycle significantly. "Under design controls, manufacturers must establish performance requirements for a device before production, ensure that device components are compatible with one another, select adequate packaging materials, and where appropriate do a risk analysis," notes FDA legislation. Design changes, such as those made to transition to lead-free, also are subject to FDA regulation including identification, documentation, and validation of new elements, and revalidation of the entire device.
To bring medical-equipment manufacturing concerns to the forefront, EMS provider Solectron held an informative webinar outlining areas that OEMs must consider when converting to lead-free. Dick Rubin, marketing director, noted that a "greening" supply chain makes exempt components more difficult to source and more expensive pushing OEMs toward lead-free faster than some environmental legislation. He noted that, for five of the six banned hazardous materials within the scope of EU and China RoHS, data collection is an OEM's main concern. For eliminating lead, however, various challenges arise. Revalidation and reliability testing are necessary but to what degree, and on what sample size? With functional, highly accelerated life testing (HALT), highly accelerated stress screening (HASS), and full-fields test as options, Solectron suggests six "practical" steps to conversion. A pilot program with a few key products can provide a benchmark of reliability in board density, circuitry, and environmental stresses. Controls of the same product (with lead) will validate any testing. To determine the proper sample size, Solectron suggests that an OEM or design firm review the products' original testing documents, and run the compliant products' tests accordingly. Solectron recommends beginning HALT, HASS, and full-field tests, and using preliminary results to direct further studies. Final test results will confirm the next step submitting the product to the FDA or shifting to redesign.
Materials data has grabbed the attention of every manufacturer converting to RoHS compliance. As directives in the EU, China, Korea, some U.S. states, Japan, Australia, and more countries change and dictate different levels of compliance on different dates, companies should focus of collecting all materials data, said David Castro, senior manager of global material engineering, Solectron. Awareness of assembly parts and materials must be more comprehensive than with original designs. Components are broken into homogenous materials a die-bond wire, for example then pure substances gold, for example. Designs that call for mixing tin/lead solder with lead-free solder balls (on a compliant BGA, for example) are unacceptable in terms of eventual product reliability, explained Jasbir Bath, process engineer for RoHS at Solectron. Production quality, materials-handling procedures, and compliant manufacturing (using compatible materials at correct process parameters) are the EMS providers' responsibilities; product reliability and compliance are the domain of the OEM. In the medical sector, compliance must have no negative effect on safety and performance of the end devices. Mixed-alloy assembly can lead to impuissant solder joints and unreliable medical instruments.
Solectron also introduced a medical alliance program (S-MAP) with ATEK Medical, Circle Medical, Proven Process Medical Devices, and SRI Product Development. The alliance is meant to circumvent supply, design, and materials issues in the transition to lead-free by providing a networked, targeted outsourcing option for transitioning medical instruments to compliance with environmental legislation. The alliance considers cost and revenue objectives as well as reliability statistics mentioned above. As more high-reliability industries are forced to convert to lead-free manufacturing, contract manufacturers may shoulder more responsibilities, such as ensuring that supplies are verified and documented, and sourcing product engineering for OEMs introducing lead-free instruments and machines without compromised reliability.
Equipment manufacturers also are targeting high-reliability markets, anticipating, as exemptions expire, a boost in capital-equipment sales mimicking what occurred when other sectors ultimately converted in July 2006. Asymtek, a Nordson company, will target the implantable medical device sector with the SC-400 PreciseCoat conformal coating system. The company believes that conformal coating can increase the life cycle and reliability of a given medical instrument by protecting circuitry from pollutants such as dust, moisture, and chemicals. Threats to solder joints vibration, mechanical and thermal stresses also may be mitigated. Implantable medical devices often are designed to be as non-invasive as possible, so the conformal-coating jet is designed to dispense onto selective areas in tight tolerances and dense layouts. A needle with non-contact jetting (a "clean" manufacturing process) and pulse-width modulated control creates 1.5-mm-wide line widths and 15-µm film thicknesses.
EMS providers looking to tap the medical-device assembly market must certify that assembly processes will yield high-reliability, consistent, and "transparent" products, due to strict government and industry regulations on these products' performance. Manufacturing sites can receive ISO-13485 certification to verify effective quality management for production, assembly, and rework-and-repair of medical equipment's electronic systems and subsystems. Quality standards for medical devices, set by the FDA, include "Current Good Manufacturing Practice (CGMP) requirements within Quality System (QS) regulation," in which product designs must account for the variability of a machine's environment, for example, a defibrillator on an ambulance. Circuitry designed for the defibrillator must withstand the electrical noise generated by the vehicle's siren, harsh-environment temperatures, and interference from communication devices used by emergency personnel. Specifications for reliability, set by the medical equipment industry and government regulations, will not be lowered when medical devices are required to go lead-free. Reviews of product design, effective testing procedures, and controlled and accurate manufacturing processes should mitigate many concerns with converting high-reliability devices to lead-free.