The Medical Battery Conference took place at the MD&M West in Anaheim, CA on February 7–9 and Battery Technology editors attended most of the sessions. Here are five takeaways from the conference:
1. Lithium battery safety certification:
In general, there are a lot of packaging requirements on secondary lithium batteries, such as:
- Safety Testing ( Short-circuit, abusive overcharge, forcer discharge, temperature, enclosure flammability)
- Marking Requirements (languages, marks, standards, artwork releases)
- National requirements (in-country testing, material compliance, factory inspections, etc.)
- Renewals (limited validity of certificate, annual fees, verification testing, regulatory changes, and more)
Managing certifications can be very difficult and time-consuming. Trying to get safety certifications takes an enormous amount of work time and effort. According to George Gerwe, president of RRC Power Solutions, it could take 28 weeks of test time to get just one battery certified. There are constantly new updates or requirements that makes certification even more challenging. There are also new countries requiring their own certifications. “I think countries are figuring out that this is a revenue gain for them. You'll see more and more countries popping up and saying, ‘You require a national certification,’” Gerwe said.
Companies like RRC Power Solutions manage all battery certificates for clients while adjusting to changes on regulations and test accordingly. They also offer standard battery solutions that would provide certifications up front skipping time to market since they are off the shelf.
2. Concerns about transportation regulations:
Lithium batteries pose a hazard when it comes to transportation. There are several certifications that battery manufacturers need to meet for safe transportation (e.g., IATA DGR, UN 38.3, IEC 26281, etc.). All batteries are regulated, and medical devices are not exempted. Even though small batteries might not generate a lot of heat during thermal runaway, they need to be regulated as well. Governments and regulatory bodies such as the United Nations (UN) and the Federal Aviation Administration (FAA) are still working on more protocols and regulation for the transportation of lithium-ion batteries.
Airlines have always asked for a safety data sheet for batteries, but the UN also proposed that lithium-ion batteries should be limited to 30% state-of-charge (SoC) when being transported. Hazmat Safety’s President, Bob Richard thinks that the UN’s proposal is an interim resolution until a packaging standard for batteries that are transported on aircraft is created. “There is a lot of test data and evidence that shows that a battery at 30% SoC, even if you're forced into thermal runaway, is going to be less violent,” Richards said, explaining that less gas means there would be less heat, less likelihood of propagation, and so on. But the Airline Pilot Association (ALPA) is also thinking of asking for the lowest practical SoC. “There could be some safety issues too if SoC is too low, it could damage our equipment, and data could even be lost,” concluded Richard.
Many of these regulations for transportation should not apply to medical equipment that contain small and miniature batteries, Richards said. The medical industry keeps challenging and educating regulatory bodies because times matter when medical equipment needs to reach patients.
3. Solid state batteries for medical applications:
Batteries are getting smaller, especially for medical applications. Ilika is a battery manufacturing company specializing in solid state battery technology solutions for Industrial IoT, and electric vehicles, as well as medical technology: John Tinson, VP of sales at Ilika, talked about the advantages of solid state batteries for medical applications and Ilika’s products. He also announced a collaboration between Ilika and Cirtec Medical that will bring Ilika’s Stereax battery technology to market.
Stereax enables disruptive product designers looking for a long life (thousands of recharges), low leakage nanoamperes (nA) and miniature power source (the first product will be 20 mm3) with rectangular form factor like ICs. Stereax can be used in several medical applications, such as cardiac sensing, smart orthopedics, smart orthodontics, smart contact lenses, and more. The thickness of the battery is just 1.0 mm with a footprint of 3.6 mm × 5.6 mm.
4. Tracking and tracing pharma products:
Starting in November 2023 The FDA will require to start tracking prescription drugs and the components. The Drug Supply Chain Security Act (DSCSA) outlines requirements or manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners) to develop and enhance drug supply chain security by 2023. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Imprint Energy—a developer of zinc based, printable, and disposable batteries—has found a product market fit for their printable batteries because they provide batteries containing exclusive high-conductivity polymer electrolyte technology that enables scalable print-based manufacturing of energy dense and ultra-thin batteries based on non-Lithium earth-abundant materials.
“Following the path of your medical product from manufacturer to inception or consumption is becoming a chain of events. It is no longer just individual things that happen, it is a chain, so these products need to have something on them to track them from start to finish,” said Imprint Energy Global VP of Business Development Michael Crane. “Therefore smart labels and things like that are really the choice.”.
5. Battery software:
The battery software market is expanding and diversifying. At the Medical Battery Show there were several software companies, such as Voltaiq, Exponent, and QAD, talking about building intelligent batteries, robust battery supply chains and data driven battery management systems.
QAD Inc. VP of Sales Bart Reitter , said, “Building a supply chain is not just about grabbing data and sharing that with partners. It is about effectively using that data. And this is fundamentally the value that QAD brings to our customers that are using that data to make automated and intelligent decisions and predictions across global end-to-end supply operations. Fundamentally, manufacturers need to fully realize that digital supply chain capabilities can help avoid supply chain risk and give them greater visibility and agility that is required.”