Battery Safety & Risk Management for Medical Devices

Capabilities

• Battery Selection & Vendor Evaluation

  Exponent's multidisciplinary scientists and engineers help manufacturers with the critical issue of battery selection and qualification for use in all types of medical devices. From off-the-shelf non-rechargeable cells to custom integrated rechargeables, we rigorously evaluate the electrochemistry and potential toxicity of prospective batteries, the electrical requirements of the devices themselves, and the ways in which both the battery and the device may interact with the user.

  Our battery vendor evaluation services for medical devices provide thorough assessment of battery manufacturing capabilities to industry best practices, encompassing everything from incoming quality control (IQC), to production line evaluations, to outgoing quality control (OQC). Our experts seek to ensure optimal performance at every stage of production, conducting detailed examinations of the entire vendor manufacturing process, identifying potential pitfalls as well as opportunities to enhance efficiency, quality, and safety.

• Risk Assessment

  As medical device companies meet growing market demand for a wider range of technologies and longer-lasting implantable medical devices, ensuring the safety and reliability of these devices — and their batteries — across their intended lifespans is critical. Exponent scientists go beyond standardized tests, offering clients rigorous risk assessments for medical device batteries across the product lifecycle, identifying potential failure modes, their likelihood, and severity.

  With deep history in failure analysis and advanced battery testing laboratories worldwide, our experts provide medical device manufacturers with critical safety evaluations to simulate realistic conditions and predict battery behavior under stress, including nail penetration testing, thermal exposure assessments, accelerated cycling and storage testing, contaminant assessments, ethylene oxide sterilization testing and risk analysis, component and system-level analysis, and more.

  Understanding the complex interaction between a medical device and its battery is crucial to characterizing a device's performance and risk profile. For medical device manufacturers seeking battery integration performance and safety, Exponent's battery consultants evaluate how a device's design impacts the function, reliability, and safety of its battery.

• Regulatory Compliance

  Our experts guide medical device manufacturers through complex regulatory approval processes, which can vary widely depending on device type and class and other factors, helping them demonstrate safety, avoid delays and additional expense, and accelerate time to market.

  Exponent provides bespoke testing, modeling, and safety evaluations for medical devices, their batteries, and their respective regulations, including FDA's 21 CFR Subchapter H and EU Battery Regulation 2023/1542. Several of our experts maintain regulatory affairs certifications (RACs), demonstrating a global understanding of regulatory strategy, or are ISO 13485 lead auditors — a globally recognized quality management systems (QMS) standard for the medical device industry.

  As implantable medical devices such as pacemakers — and their batteries — have become common, patient exposure to electromagnetic fields during magnetic resonance imaging (MRI) has come under greater scrutiny. FDA and the EU MDR require manufacturers to label their devices as "MR Safe," "MR Conditional," or "MR Unsafe," based on properly conducted risk assessments. Exponent provides manufacturers of medical devices with rigorous device, battery, and MRI compatibility testing in accordance with ISO 10974 to help mitigate MRI risks and support regulatory compliance.

  Case study

  How Can We Ensure Implantable Medical Devices Allow for Life-Saving Imaging?

  An active implanted medical device company needed help gaining MRI Conditional approval for their product and turned to Exponent for wide-ranging testing support to ensure its safety.

  

• Manufacturing Quality Control

  Mitigating the risk of battery and product failure from manufacturing defects, environmental factors, and design factors — and related patient or user risk — is of the utmost importance for manufacturers of medical devices. Exponent helps battery manufacturers and makers of portable and implantable medical devices improve product quality with detailed cell quality analysis, in-depth evaluations of cell construction, and rigorous assessments of battery cycling performance.

  Additionally, our team conducts thorough factory audits to support compliance with industry standards and best practices. By leveraging advanced methodologies and cutting-edge technology, we help manufacturers maintain the highest levels of quality control and product excellence so their medical device batteries can meet stringent performance and reliability criteria.

• Postmarket Surveillance

  To monitor the performance and safety of medical device batteries after they have been placed on the market, Exponent's multidisciplinary team helps clients collect, analyze, and interpret available market and regulatory data — including from FDA and other regulatory bodies worldwide — to identify patterns and potential risks. Our postmarket surveillance support and analysis provides manufacturers of medical devices with key insights into adverse events, possible risks, and determinations of need for preventive or corrective action.

• Failure Analysis

  While portable and implantable medical devices support life-changing medical interventions, battery failures for these technologies carry significant risk for users and patients alike. Exponent offers manufacturers of medical devices and batteries industry leading battery failure analysis to determine the root causes of failures and identify corrective actions.

  As factors of battery chemistry and design are specific to wearable and implantable medical device applications, so are their respective failure mechanisms. Exponent's understanding of battery chemistries, applications, and failure mechanisms allows us to efficiently investigate and draw conclusions as to the cause of a failure and guide manufacturers through appropriate next steps, including mitigation and, if necessary, product recall.