SSSD 2018 Program

SSSD Submittal Instructions

1. Abstracts and Presentations Submissions shall be send via email directly to SSSD Track Chairs; ME Track Chair – Fabio Furlan and ITE/Battery Track Chair - Grant Schmidbauer  

2.    Abstract Submission: closed 

3.    Register on-line to SSSDNote that all participants are required to register (and pay) for the SSSD event, including all presenters and volunteers.

3.    Submit Final Presentation on the SSSD template prior Final Presentation Submission Deadline.  SSSD PP template

Presentation Abstracts 

Medical Devices Track I
 

HW-01 Medical Robots - Introduction

Diagnostic Systems, Robot assisted surgery or therapy, Rehabilitation systems, Other medical robots.

Standards and Regulations (EU & US/Canada), IEC DIS 80601-2-77 / -2-78 (US TAG Committee Meeting notes), Hazard Identification and Risk Assessment, ISO 13849 – Functional Safety, US Standards and Regulations, how it works FDA view on Medical Robots, Other EU Directives
Uwe Meyer - TUV-Rh

Uwe is a Business Field Manager for Medical and is responsible for the overall management of the Medical Testing business unit, new business development and team oversight. He has more than 20 years of experience in regulatory product testing and certification. Uwe also participates on technical / industry committees and supports accreditation programs for TÜV Rheinland of North America’s Safety Testing business lines. He is also a frequent speaker at conferences and webinars

HW-02 Medical Devices – Convergence of Design and Process Standards and Regulations

The advent of EN/IEC 60601-1:2012, EN ISO 13485:2016 and the coming EU Medical Device Regulation (MDR) has brought about a convergence of traditional design requirements and development process requirements for engineers and other professionals directly involved in the design and development process.  This convergence has extended beyond the traditional Design Control process into many other areas of the Quality Management System (QMS) and continues throughout the product lifecycle.  This session will highlight key aspects of this convergence and present a strategy and process to integrate this convergence into the design process and other affected areas of the QMS.
Bob Duffy - Consultant

Bob has nearly 30 years in medical device design and development, on top of over 15 years in manufacturing.  His product design experience includes pulse oximeters, anesthetic gas monitors, infusion pumps, interventional cardiovascular devices, multi-parameter monitors, nerve and muscle stimulators, and other devices.  His manufacturing experience includes electronic assembly, mechanical part manufacturing and materials management in California’s Silicon Valley.  He was an inventor on (13) medical device patents.  He was the original project leader for one of the most successful medical devices in the past decade, providing in excess of $1.0 billion in revenues.  Bob heads up his own consulting company, Bob Duffy Associates, helping medical device companies overcome hurdles in design, manufacturing, and Regulatory and Standards compliance.  Bob is also an instructor at UCSD Extension in Quality Management Systems for Medical Devices and Design Control for Medical Devices.

HW-03 Home Healthcare Ventilators for Ventilator- dependent patients - IEC 80601-2-72:17

Identifying the different features and functions of the ventilator.

Doing this in the beginning will help you evaluating all the requirements that apply.

This will help you to manage the testing process seamlessly

It will also help you to communicate these requirements to the Manufacturer.

By the end of this presentation you will gain the knowledge on how identify and classify the different features and formulate an effective test plan for a Home Healthcare Ventilator.
Vamsee Patta - CSA

Vamsee a Technical Training Specialist for Medical for CSA Group. Vamsee believes standards play a key role  in ensuring a  safer , better and sustainable medical equipment. Vamsee has extensive knowledge and experience in testing related to requirements for basic safety and essential performance for Respiratory Care and Patient Monitoring Equipment. Vamsee holds a   Bachelor of Technology from Jawaharlal Nehru Technology University, Hyderabad.  He has spent the last 10 years testing Medical Equipment for requirements of IEC 60601-1 series of standards.

HW-04 Medical Device Cybersecurity

In our presentation, we discuss various aspects of medical device cybersecurity. This is particularly important for manufacturers preparing to submit new network-connected devices and software via the FDA 510(k) submission process. We will also provide an overview of security design considerations recommended by the FDA Guidance as well as key processes assuring security risks are managed for products currently in the market. What you will learn:

  • Learn various aspects of medical device cybersecurity

  • Understand security design considerations recommended by the FDA Guidance

  • Discover key processes assuring security risks are managed for products currently in the market

  • Understand testing strategies that support your product security claims

  • See how the standards correspond to FDA guidance

Andre Bedard - UL

André has been part of UL’s Life Health Science division for the last 3 years. He joined UL after spending over a decade working for Notified Bodies BSi and TUV where he focused extensively on clients for active medical and laboratory equipment with testing, inspections and certifications services. André has successfully interfaced with CEO’s, RA/QA, R&D engineers, medical start-up companies, and Invitro-Diagnostic device manufacturers advising on regulatory conformity path solutions to include IEC 60601-1-2 and IEC 61326 for EMC/EMI, IEC 60601-1, IEC 61010, CB, NRTL, Risk Management requirements per ISO 14971, Human Factors Usability studies per ISO 62366, as well as CE Marking MDR, IVDR and ISO 13485 global certification requirements.

HW-05 Current Trends in Electromedical Equipment Standards

Major advances in medical technologies over the last few decades have contributed to early diagnosis of diseases, more efficient delivery of treatment, and longer healthier lives. From switches to swipes, from hardware to apps or from the hospital to the home environment, healthcare devices continue to undergo a paradigm shift. To keep up with these advances, and to compete in a highly competitive and complex market, healthcare systems and medical devices must evolve to support and reflect this rapid pace of innovation. Ensuring that these systems and devices are safe for usage by both trained medical professionals as well as inexperienced home users is critical to business success and public safety.  As a result, manufacturers find themselves in a constantly changing environment of safety, conformity and market access requirements – an environment in which they cannot afford to fall behind.  This presentation will provide an overview of the current trends in electromedical equipment standards, as it relates to IEC/ISO 60601 series of standards, including an introduction of the history of the medical robot and future considerations medical robotic applications.

Upon completion, participants will enhance their knowledge in the following key areas:

  • Basic safety and essential performance requirements for electromedical equipment

  • Medical robotic definitions and applications

Naysahn Saeed - CSA

Naysahn has been working for CSA Group for the last 10 years certifying medical devices around the globe. He has developed and delivered training on medical device safety and risk management in the US, Europe, and Asia. Prior to his time at CSA, Naysahn worked for a medical device manufacturer, where he took on Risk Management responsibilities as the company went through FDA audits as a result of a Consent Decree.  Naysahn is also a qualified Technical Assessor within the IECEE CB Scheme, although in his free time he much prefers “assessing” golf courses to assessing laboratories. 

 

HW-04 New Medical Device Standards and Hazard Based Safety Engineering

The risk management focused trend initiated with IEC 60601-1:2005 has continued to take center stage with new ISO 1385:2016 Quality Management System (QMS) Standard, IEC 60601-1-2:2014 EMC Standard, IEC 62304:2015 Software Lifecycle Standard and IEC 62366:2014/IEC 62366-1:2015 Usability Engineering Standard.  One key result of these updates is to encourage a Hazard-based safety engineering approach that goes beyond the traditional Failure Modes Effects Analysis (FMEA) approach.  This session will cover key aspects of these Standards updates, and present a strategy and process to integrate this Hazard-based safety engineering approach to the established design and development process.
Bob Duffy - Consultant

Bob has nearly 30 years in medical device design and development, on top of over 15 years in manufacturing.  His product design experience includes pulse oximeters, anesthetic gas monitors, infusion pumps, interventional cardiovascular devices, multi-parameter monitors, nerve and muscle stimulators, and other devices.  His manufacturing experience includes electronic assembly, mechanical part manufacturing and materials management in California’s Silicon Valley.  He was an inventor on (13) medical device patents.  He was the original project leader for one of the most successful medical devices in the past decade, providing in excess of $1.0 billion in revenues.  Bob heads up his own consulting company, Bob Duffy Associates, helping medical device companies overcome hurdles in design, manufacturing, and Regulatory and Standards compliance. Bob is also an instructor at UCSD Extension in Quality Management Systems for Medical Devices and Design Control for Medical Devices.

 

ITE Track II
 

HE-01 GMA overview

Global Market Access overview; Navigating the regulatory landscape of global markets is a complex and challenging task; this presentation will cover:

- What is Global Market Access (GMA), - Regulatory Overview, - Approval Procedures, - 10 Challenges In Obtaining Global Approvals
Hollie Gillespie / Nicole Tatum - UL

Hollie is a Global Market Access Operations Leader at UL where she has worked for the past 25 years.  She has held positions in both Operations and Sales.  When she’s not working she likes to enjoy outdoor activities with family such as gardening, camping and biking

HE-02 SAR

With the increased sophistication of consumer products and medical devices both external and implants, there is a growing need for flexible high-speed communication with the device or implant. Extended range and communication speed are now achieved by new technologies increasing the carrier frequency and the bandwidth. All these devices have to meet the RF exposure requirements that has been set in most countries around the world. This presentation will give a brief overview of the different requirements that will be necessary to get a device approved that contains a wireless transmitter. Further, there will be a discussion of some of the items a designer can keep in mind to determine if they can lessen the RF exposure burden. Through the discussion, the presentation will cover both the MPE requirements and the SAR requirements.
Jay Moulton - RF Exposure Labs

Jay is the owner of RF Exposure Lab, a privately held SAR testing facility in Southern California.  He earned a BS in Electrical Engineering and an MBA from Chapman University.  Before starting RF Exposure Lab, he worked for QUALCOMM as Director of Regulatory Engineering and had previously worked for AT&T.  Jay has over 30 years of regulatory experience with the last 20+ years specializing in SAR.  He contributed to and supported the writing of the IEEE 1528 which became the first SAR industry standard.  In addition to his extensive work with some of the biggest companies in the industry, he has conducted training and seminars for various companies & industry groups to keep them ahead on SAR regulations and design requirements.

HE-03 Risk assessment for EU directives

Risk assessment for LVD and EMC directives, what are the rules and what must manufacturers do to comply?
Patty Knudsen - Teradata

Patty Knudsen has been in the product safety field for over 30 years.  As a certification engineer for TUV Rheinland she tested information technology equipment, industrial machinery, household, and test and measurement products.  As an engineer in the private sector she has also tested telecommunications equipment and medical devices.

HE-04 IEC 62368-1 3rd ed., what to expect

Summary of Key Changes in IEC 62368-1, 3rd Edition (Compared to 2nd Edition) and impact points manufacturers have going from IEC 60950-1 to IEC 62368-1.
Grant Schmidbauer - Nemko

Grant has more than 34 years of experience in the field of International Product Compliance and Global Market Access covering product areas Information Technology, Medical, Telecom, Power Supplies, Laboratory, Test and Measurement, Household/Commercial and Audio/Video.
Employment includes CSA (11 years), TUV Product Service (2 years) and Nemko (22+ years).
Graduate from the British Columbia Institute of Technology (BCIT), Vancouver BC, in Power Electronics, then started his career in the field of International Product Compliance soon after.
Grant is the Sr. Vice President, Region North America, in the Nemko Group, and the President of Nemko North America, Inc., and Nemko USA, Inc.
Grant is responsible for Region North America including Nemko USA with operations in San Diego CA, Dallas TX and Salt Lake City UT; and Nemko Canada with operations in Ottawa Ontario and Montreal, Quebec (Canada).
Grant is an IEEE Sr. member in the Product Safety Engineering Society (PSES). Grant is also on the Board of Directors of the PSES, participating as BoD member-at-large.

HE-05 Functional Safety Certification of Software-only Products

Functional safety, often specified or referred to by particular ratings such as SIL or ASIL, applies to protective functions or safety-critical control functions at the level of a system or end-product (e.g. hydraulic press, mobile robot, distillation column, GFCI, passenger car, …).  What does functional safety imply then for suppliers of subsystems and components for such systems and end-products? In particular, what does functional safety mean for software-only suppliers? The presentation will discuss what it takes for a software-only products to be compliant with standards such as IEC 61508 and ISO 26262, what the value of independent assessment and certification could be, and how such a certification is performed in practical terms. The presentation will distinguish between two important categories of software-only products: embedded software that eventually will run on-board a car or inside a machine, and development support tools such as compilers and EDA tools.

DR. Thomas Maier - TÜV SÜD

Thomas is a Business Development Manager at TÜV SÜD Rail since July 2016.
6 years at UL, principal engineer for functional safety, 8 years with Danfoss Drives, functional safety in motion control. 
3 years at LM Ericsson A/S: software processes and tools, CMMi, UML and SDL.
3 years at Daimler-Benz: system safety and functional safety of drive-by-wire systems and in avionics. 
4 years at the Joint Research Centre of the European Commission: system & software safety in fusion technology.
International standardization (ISO 26262, ISO 13849 & IEC 62061, IEC 61800-5-2, IEC 61508 maintenance, UL 1998).
Dr.-Ing. from University of Stuttgart

HE-06 Fundamentals of Hi-Pot Testing – Navigating Electrical Safety Standards and Creating a Safe Testing Environment

Electrical safety testers – often referred to as “Hi-Pot” testers get their name from the high-potential (high voltage) they produce to perform dielectric withstand and insulation resistance tests. These testers are an integral part of electrical and electronic equipment manufacturing since electrical safety testing and certification is a requirement for virtually every electronic device and electrical apparatus.

But it can be daunting to navigate the requirements of what constitutes a certified product since compliance depends upon a large number (hundreds) of safety standards – as well as the region of the world where the device will be sold and used. Moreover, the potentially lethal voltages and currents involved in the testing process makes it critical for the user to clearly understand equipment setup and operating procedures.

This presentation describes the functions and features of advanced hipot testing instruments that are optimized to meet the stringent standards and certification requirements for electrical safety production testing. It also provides guidelines for creating the proper environment for using the hipot tester safely and accurately.
Chad Clark / Kathy Naraghi - Vitrek

Chad Clark hold a position of Director of Business Development at Vitrek.  Chad Clark has been with Vitrek LLC since 2008. Over the years Chad has had the opportunity to work directly with end users to develop safe methods and procedures enabling countless products to be NRTL safety listed.  Vitrek is a leader in high voltage compliance test and measurement. Chad holds a BE in Economics for California State University - Long Beach.
 

Battery / Other Track III
 

SR-01 Introduction to lithium-ion battery technology

Driven by consumer demands, industry leaders are becoming increasingly concerned about the safety of their products that contain lithium-ion batteries but are often challenged by how to make improvements in safety that maintain the original functionality and usability of the product. Simply understanding the differences between the commercially available types of lithium-ion cells can be a challenge, as the types of form factors, component materials, and chemistry can vary significantly. This talk will provide a primer on lithium-ion battery technology – ranging from the fundamentals of how the technology works, different cell designs, and materials used. This talk will conclude with a discussion of what happens when a lithium-ion safety event occurs, and how cell design can affect the severity and/or likelihood of these events.
Rachel Licht  - Exponent

Rachel Licht is a Senior Associate at Exponent, a failure analysis and technical consulting firm. She specializes in lithium-ion battery cell chemistry, including manufacturing best practices, cell lifetime performance and aging, device application, and failure analysis of thermal and swollen cells. Rachel has a Ph.D. in Chemical Engineering from the University of California, Berkeley and a B.S. in Chemical Engineering from the Massachusetts Institute of Technology.

SR-02 Fundamentals of lithium-ion technology

Despite the ubiquitous use of lithium-ion batteries in mobile electronic devices, the technology is not perfect. When properly designed, manufactured, and handled, lithium-ion cells and packs can provide safe and reliable portable energy storage. Unfortunately, the list of possible ways to compromise the safety and reliability of battery cells and packs is not short, and the cost and effort required by product designers and manufacturers to ensure safe and reliable cells is not trivial.

In this presentation we will expand on the fundamentals of lithium-ion technology presented in the earlier talk by Exponent to discuss the mechanisms through which cells experience performance and / or safety issues, review several case studies, and end with a discussion of strategies for mitigating the risk of such failures. The contents of this talk will draw heavily from the collective experience of a leading failure analysis firm that has been involved with numerous investigations into lithium-ion battery failures and recalls, and the talk will be relevant across many different product types from wearables to consumer electronics, automotive applications, and stationary storage.
Keith Beers  - Exponent

Keith Beers is a Senior Managing Engineer at Exponent, a failure analysis and technical consulting firm. He assists clients in managing the risks related to products containing lithium-ion batteries through proactive battery qualification studies, risk mitigation strategies such as FMEA, failure analysis, and provides product recall support. Keith holds degrees in Chemical Engineering, with a Ph.D. from the University of California, Berkeley and a B.S. from the University of Colorado, Boulder. He is also a licensed chemical engineer by the California Board for Professional Engineers and Land Surveyors.

SR-03 Battery testing, including lessons learned

The paper will provide an overview of international lithium ion battery testing requirements examine recent battery failures and summarize possible lessons manufacturers may learn from those incidents.
Cathy Pell - Plantronics

Cathy Pell is presently Senior Regulatory Compliance Engineer at the global headquarters of Plantronics Inc. in Santa Cruz, California. In this role, she carries sole responsibility of battery and power supply approvals. Catherine is also a member of the Habitat Soundscaping project team. Catherine has considerable international product certifications knowledge with a specialty in Asia Pacific type approvals. She began her career at Underwriters Laboratories (UL) and past employers include Ericson, Nokia and Siemens. Catherine joined Plantronics in January of 2005 and is a key member of the Santa Cruz compliance engineering team. Catherine holds a B.A. in Psychology from an American honors college – St. Mary’s College of Maryland – and completed comprehensive coursework in electrical engineering at DeAnza, West Valley and Foothill Colleges. Catherine has over 30 years of ITE compliance engineering experience and is a Senior Member of the IEEE. Additionally, she is a member of the IEEE Product Safety Engineering; and IEEE Women in Engineering Societies.

SR-04 Battery safety requirements

Country Specific Battery Safety Requirements, global overview of mandatory battery certification requirements in countries including European Union/CE marking, India, Japan, South Korea, and Thailand; and voluntary country requirements in countries including China, Customs Union/EAC, Russia, Taiwan, USA/Canada, and Vietnam; as well touch on transportation requirements according to UN/DOT 38.3 and IEC 62281.
Hollie Gillespie / Nicole Tatum - UL

Hollie Gillespie is a Global Market Access Operations Leader at UL where she has worked for the past 25 years.  She has held positions in both Operations and Sales.  When she’s not working she likes to enjoy outdoor activities with family such as gardening, camping and biking. 

SR-05 The Relationship Between Product Security and Cybersecurity for IoT Enabled Solutions

Cybersecurity affects us all, in part because even attackers with only basic skills have the potential to cause real harm. Sophisticated attackers can disrupt the electronic controls of our power grids, water treatment plants, telecommunications networks, and consumer products. They undermine our privacy by stealing our personal information. 

As more and more products are introduced to the IoT ecosystem that contain features and functions that are exciting and very attractive, the capabilities of these products must also be guarded against intrusion. The “intelligence” of these items whether it be medical devices, door locks, thermostats, vacuum cleaners, clothes washers, and other edge devices bring exceptional value and improve our quality of life.

Our presentation will concentrate on key cybersecurity activities across the entire IoT product lifecycle that have the greatest impact and relevance for IoT innovators.   We will focus on process, design, and testing activities that should be considered for managing cybersecurity throughout a product lifecycle and will examine various methods to baseline and maintain both organizational and product cyber worthiness. This will include security management systems, secure development lifecycle essentials, standards gap analysis, and best practice test and security validation methods. 

Laura Elan - CSA

Laura Élan is a recent addition to the CSA Group Innovation Team in the role of Sr. Cybersecurity Manager, supporting several industry verticals including Heatlhcare Solutions.  Prior to joining the CSA Group, she served as the Cybersecurity Practice Lead for UL’s Digital Health Service team, supporting medical device software and solutions customers in meeting regulatory and business imperatives for software and cybersecurity assurance.  Laura has more than 30 years of software and product development and compliance engineering experience, grounded in several decades of senior leadership roles with R&D and Manufacturing organizations including Medical Devices, Commercial and Consumer Electronics companies.  Laura holds a BSEE from the University of Illinois, Urbana, and an MSEE from the Illinois Institute of Technology, Chicago and is currently pursuing a Graduate Degree in Computer Science with a focus on cybersecurity.  She is a licensed Professional Engineer in the State of Illinois and holds the RAC credential from the Regulatory Affairs Professionals Society. 

EMC IEC 60601-1-2, 4th Ed, Manufacturers Responsibilities

While the standard IEC 60601-1-2, 4th Ed does change some of the test values, other changes in the standard place an additional responsibility on the manufacturer. This additional responsibility can lead to delays when submitting to the test lab. The manufacturer needs to understand the additional responsibilities, the impact of the responsibilities and determine the best steps forward to prevent delays in testing. Addressing these new items up front, can ensure the testing is conducted correctly the first time. What you will learn:
To address these additional responsibilities the following topics will be discussed: the role of Risk Management from the standpoint of IEC 60601-1-2, developing Instructions for Use that address specific environments, and the development of the test plan as required in the 4th Edition.
Andre Bedard - UL

André Bedard has been part of UL’s Life Health Science division for the last 3 years. He joined UL after spending over a decade working for Notified Bodies BSi and TUV where he focused extensively on clients for active medical and laboratory equipment with testing, inspections and certifications services. André has successfully interfaced with CEO’s, RA/QA, R&D engineers, medical start-up companies, and Invitro-Diagnostic device manufacturers advising on regulatory conformity path solutions to include IEC 60601-1-2 and IEC 61326 for EMC/EMI, IEC 60601-1, IEC 61010, CB, NRTL, Risk Management requirements per ISO 14971, Human Factors Usability studies per ISO 62366, as well as CE Marking MDR, IVDR and ISO 13485 global certification requirements.