TUT13: Advanced Battery Design and Selection Criteria for Medical Device Applications
WEDNESDAY, JULY 29 | 5:45 - 8:00 PM (DINNER PROVIDED)
ABOUT THIS TUTORIAL:
Next-generation wearable, implantable, surgical, and portable medical devices are revolutionizing healthcare. Patient outcomes and standardization of care continue to benefit from these smarter and more connected medical devices. Such devices often require
safe, higher energy density batteries with specialized design considerations. Whether you’re a medical device battery expert or a just beginning to explore this specialty, this tutorial will provide engineers, designers, product managers, and
component and materials suppliers with an interactive overview of the design criteria and other aspects that should be taken into consideration for medical device batteries. Some of the topics that will be covered include common design factors (safety,
reliability, size, weight, battery chemistry, power output, battery life, charging, and cost), supply chain management, data and lifecycle management, quality assurance, battery management systems, modeling, and design for manufacturing.
TUTORIAL AGENDA:
5:45 Tutorial Introduction
6:05 Batteries for Medical Applications
Jack Guo, Co-Leader, Battery Platform Team, Royal Philips
Medical device applications have various unique needs for batteries. This brings challenges to battery design, medical device and application design, supply chain design and management, and lifecycle management. This presentation will provide product
managers, medical solution and service architects, design engineers, and procurement leaders with an overview of the best practices of design, supply chain management, data and lifecycle management, and quality assurance that should be taken into
consideration for medical device applications to benefit the customers and to deliver business objectives.
6:25 Physics-Based Battery Management Systems for Medical Devices
Sergio Mendoza, PhD, Battery Specialist, Exponent
The increased demand for reliable portable medical devices operating for extended periods on a single charge is a great fit for both lithium primary (single-use) and lithium-ion (rechargeable) battery technologies. The benefits of these technologies include:
1) larger power and energy densities; 2) low self-discharge rates; and 3) a variety of form factors and chemistries that are compatible for different requirements. However, for both performance and safety, lithium battery technologies require active
battery management. The battery management system (BMS) performs a number of functions. Some safety-related functions include preventing cell overcharge, overdischarge, and operation outside allowable temperatures. Some performance-related functions
include estimating the battery’s state of charge (SOC), tracking the battery’s state of health (SOH), and electrical balancing of cells in strings (balancing is also important for safety). The purpose of this presentation is to examine
physics-based requirements for battery management systems in medical devices and to understand how these requirements vary over the lifespan of the battery system.
6:45 Battery Design, Development and Quality Control in Manufacturing
Speaker to be Announced
Custom design of electrochemical cells is typically needed for implantable medical devices. Given the nature and variety of device applications, battery requirements vary widely. Power consumption, device longevity expectations, Maximum current
draw, volume constraints, primary or rechargeable, shape limitations, dimensional tolerances, and electrical interface are just a few of the inputs that need to be considered when developing a custom battery for these applications. In this presentation
design inputs for various types of implanted applications will be discussed along with how they drive the final battery design decisions, capabilities and validations.
7:05 Batteries for Medical Devices: Regulatory Tools to Promote Innovation
Iacovos Kyprianou, PhD, Senior Science Health Advisor, FDA
As batteries become more powerful, portable, and reliable and smart devices are infiltrating all areas of medicine, the trend is to see more and more medical devices becoming mobile and battery powered. The Food and Drug Administration's Center for Devices
and Radiological Health is committed to advancing public health by helping to bring innovative technologies to market and providing reasonable assurance that the medical devices already on the market continue to be safe and effective. In this talk
we will discuss the opportunities and regulatory tools for promoting innovation in battery powered medical devices and ensuring their safety and reliability.
7:25 Q&A with Attendees/Speakers
8:00 Tutorial Ends
INSTRUCTORS:
Jack
Guo, Co-Leader, Battery Platform Team, Royal Philips
Jack Guo has been with Philips for 21 years, focused on innovation, product research and development. His work has spanned from medical device and software solution development, to innovation collaboration, data and platform integration, and lifecycle
management. Jack has brought multiple products from concept to markets in his career in medical device industry. He is currently co-leading the Battery Platform Team within Philips that provides battery realization platform and integrated solutions
to medical applications.
Sergio Mendoza, PhD, Battery Specialist, Exponent
Dr. Mendoza is a Battery Specialist at Exponent. He builds on his controls background to perform multi-level analysis on electrified systems pertaining to different industries including automotive, medical, and consumer electronics. Prior to joining Exponent,
Dr. Mendoza was a Battery Controls Software Lead Engineer at General Motors (GM). His efforts focused on developing control software for propulsion batteries and battery management systems (BMS). He validated the controls software using Hardware In
the Loop (HIL) setups and he executed tests for functional and performance validation. Dr. Mendoza’s areas of expertise include optimal experimental design, model-based control strategies (e.g., energy, power, and thermal) for battery powered
systems, and diagnostics of lithium-ion battery packs. Furthermore, Dr. Mendoza applies his extensive knowledge of lithium-ion cells and systems background to conduct Design Failure Mode and Effects Analysis (DFMEA) and safety analyses including Preliminary
Hazard Analyses (PHA).
Iacovos Kyprianou, PhD, Senior Science Health Advisor, FDA
Dr. Kyprianou has been coordinating the Center’s policy for battery powered medical devices since 2011. He has been at the US Food and Drug Administration, Center for Devices and Radiological Health since 2004. He started his career at the FDA as
a research imaging scientist and since 2011 he has been coordinating the Center’s regulatory science priorities, addressing medical device-related, emerging public health and cybersecurity issues.
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