‹‹ Wed Morning Abstracts | Wed Afternoon Abstracts | Thu Morning Abstracts | Thu Afternoon Abstracts ››
Wednesday Afternoon Session Details
*Program subject to change
For Wednesday Full Day schedule click here
Download HWG2019 tentative program pdf.
| Authors |
Steven Abrahamson, GE Healthcare
|
| Title |
Medical Device Cyber Security - How Does Security Align with Quality?
|
| Session |
Type: Submitted
Theme: Cyber Security
Time: Wednesday May 01, 2019, 01:00 PM
Room: Ballroom 2
|
| Abstract |
Healthcare cybersecurity is now recognized as critical to our ability to improve the quality of healthcare and access to healthcare. Failure to effectively manage this risk can have significant adverse effect on safety of patient care, privacy of patient data, and the availability of medical devices to provide care. In May 2017 the initiation of the cyberattack known as “WannaCry” was a wake-up call to those who had been ignoring the problem. Given this level of impact, what is the relationship between Security and Quality? Is Security a set of requirements that can be addressed fully within the Quality System? How is it aligned with Quality System Regulations (e.g. US FDA 21CFR Part 820)? This session will discuss these relevant topics and how thinking on these has evolved over the last 5 years. This session will also address various perspectives on the meaning of “quality” and how an MDM can consider security as quality within an overall program of collaborative risk management within the healthcare ecosystem.
|
| Authors |
Randall Russell, Ex Nihilo Systems
|
| Title |
Case Study: Stakeholder Value Model and Compartmental Decisions Matrix
|
| Session |
Type: Invited
Theme: Healthcare Delivery
Time: Wednesday May 01, 2019, 01:00 PM
Room: Lindbergh
|
| Abstract |
Applying lessons learned from medical device technical development project informed and enabled a strategic technology initiative for realized stakeholder value in a cross functional solution design, development and implementation. Discussion of context, objectives, challenges and resolutions. Presentation of methods and analytic tools to demonstrate the optimal solution space in a constraint exposure.
|
| Authors |
Mark Fiebig, Philips Healthcare - Emergency Care and Resuscitation
|
| Title |
Saving Cost and Schedule through Early-Phase Systems Engineering
|
| Session |
Type: Submitted
Theme: Systems - General
Time: Wednesday May 01, 2019, 01:00 PM
Room: Ballroom 1
|
| Abstract |
Philips Healthcare Emergency Care and Resuscitation develops and markets automated external defibrillator (AED) systems and accessories. Since Philips AEDs have an array of use cases and users, from medical professionals to lay users, early-phase systems engineering is especially critical in establishing groundwork for product requirements. This presentation is a case study that highlights the benefits of upfront system engineering, specifically in determining user stories to bound a product’s working environment. The case study relates to product development of an AED carrying case for aviation applications. Through discussion of the lessons learned during development, the presentation will emphasize best practices that reduce development costs, improve product quality, and minimize design iterations after release to market.
|
| Authors |
Samuel Alper, Bold Insight
|
| Title |
Using qualitative system analysis of healthcare systems and human factors to identify opportunities for medical device design
|
| Session |
Type: Submitted
Theme: Healthcare Delivery
Time: Wednesday May 01, 2019, 01:30 PM
Room: Lindbergh
|
| Abstract |
Understanding how people interact with systems can lead to better design of medical devices and connected technologies. This is because system analysis methodologies can identify situations in which people lack support within an organization or a system to some degree – and these situations often highlight user needs that are partially or fully unmet. For example, one could examine the process a patient follows leading up to surgery and note areas that are difficult for the patient. Each difficulty encountered by the patient may indicate an opportunity for a new, or an improved, medical device or connected technology to better support the patient and the healthcare system. In this presentation, we will discuss methodologies for analyzing a system and the types of insights that can come from understanding how people interact with systems.
|
| Authors |
Paul Kostek, Base 2 Solutions
|
| Title |
Getting Started with Tools and Requirements Management
|
| Session |
Type: Submitted
Theme: SE skills and Tools
Time: Wednesday May 01, 2019, 01:30 PM
Room: Ballroom 1
|
| Abstract |
In today’s engineering environment the need for requirements and requirements management is a given. Good requirements help keep projects on track, ensure the needs of the customer/user are met and provide a baseline for the V&V team. A good process and tool can prevent scope creep as changes are managed and traced. This talk will describe best practices in getting started with requirements management tools.
While many tools are introduced as silver bullets, the reality is the introduction of a process and tool takes time, effort to learn, and impacts processes. Schedules will likely expand and not compress on the first project to use a tool. I’ll walk through an example of how introducing SE can help a company focus on results and create an efficient process to document projects and build the required deliverables (DHF/DMR) to support an FDA audit.
|
| Authors |
Bryan Simmons, Medela, LLC (Sponsored by Cognition)
|
| Title |
Challenges of Scale in Medical Device Development -or- The Care and Feeding of Design Controls
|
| Session |
Type: Platinum Sponsor
Theme: Sponsor
Time: Wednesday May 01, 2019, 02:15 PM
Room: Ballroom
|
| Abstract |
Many factors with broad scale can affect the systems approach to developing and marketing medical device products. These include organizational size and maturity, device risk profile, device complexity, product volume, product market and others. Recognizing these factors and applying simple principles can help the systems engineer foster an environment for the timely and economic development of high-quality cost-effective medical device products.
|
| Authors |
Joel Hutchinson, Product Manager JAMA Software
|
| Title |
Risk Management and Resilient Design in an Agile Setting
|
| Session |
Type: Platinum Sponsor
Theme: Sponsor
Time: Wednesday May 01, 2019, 02:45 PM
Room: Ballroom
|
| Abstract |
With a high cost to failure and increasing complexity, System Engineers in a medical and healthcare setting have a unique opportunity to advance the traditional Risk Management process with a Systems of Systems approach and incorporate Resilient design into their models. We’ll tackle best practices for doing Risk iteratively and accounting for resiliency, human factors, cybersecurity and other challenges.
The audience will learn:
• Best practices for incorporating Risk Management into your Agile systems approach
• Approaches to Resiliency and challenges to extending the traditional approach to Risk Management
• How to remove silos and tunnel thinking when considering Risk in a Systems of Systems context
|
| Authors |
Eli Snell, Proteus Digital Health
|
| Title |
The Journey Continues: Scaling Agile Development Processes for Multiple Therapeutic Area Solutions
|
| Session |
Type: Invited
Theme: Agile Methods
Time: Wednesday May 01, 2019, 03:45 PM
Room: Ballroom 1
|
| Abstract |
A few years ago, Proteus Digital Health embarked on a journey of agile transformation. We developed processes that were compliant with regulations and standards and that aligned with agile principles to develop our Discover product, a digital medicine platform. Now, we face a challenge of scale. We need to develop multiple therapeutic area solutions in parallel and continue to invest in a configurable platform to support additional solutions in the future.
|
| Authors |
Bill Hagestad II, Medtronic
|
| Title |
21st Century Chinese Cyber Warfare
|
| Session |
Type: Submitted
Theme: Cyber Security
Time: Wednesday May 01, 2019, 03:45 PM
Room: Ballroom 2
|
| Abstract |
21st Century Chinese Cyber Warfare will provide the audience with a firsthand, field=experienced view into the People's Republic of China's use of networked systems as a strategic weapon system. The Chinese call it the "Chinese Dream", as of late, China's President Xi Jinping is advocating for Made in China 2025 - audience members will learn about the political, cultural, historical and linguistics facets that comprise China's Quest for Informatization. Key elements of China's Informatization strategy will be covered including the People's Liberation Army's combined cyber arms capabilities; the secretive Ministry of State Security (MSS) 1,000 China Experts Plan and of course the cyber espionage efforts of State Owned Enterprises such as Huawei and ZTE. Mr. Hagestad will bring you face to face with Chinese hackers based within the People's Republic of China. You will never leave your computer unlocked after this exciting presentation 21st Century Chinese Cyber Warfare.
|
| Authors |
Bohdan Oppenheim, Loyola Marymount University and Michael Kanter, Kaiser Permanente
|
| Title |
The Evils of Healthcare Fragmentation and SE Solutions at KP
|
| Session |
Type: Invited
Theme: Healthcare Delivery
Time: Wednesday May 01, 2019, 03:45 PM
Room: Lindbergh
|
| Abstract |
The presentation will describe the evils of fragmentation in healthcare and will demonstrate solutions in both smaller reactive care situations using selected SE tools, as well as the "big bang" approach to integration of preventive and chronic care at Kaiser Permanente using the "Complete Care" approach.
|
| Authors |
Matthew Hause, PTC
|
| Title |
Performing Trade-Off Analysis within an MBSE Environment
|
| Session |
Type: Submitted
Theme: MBSE
Time: Wednesday May 01, 2019, 03:45 PM
Room: Wright
|
| Abstract |
A trade-off study consists of “comparing the characteristics of each system element and of each candidate system architecture to determine the solution that best globally balances the assessment criteria. The various characteristics analyzed are gathered in cost analysis, technical risks analysis, and effectiveness analysis.” (NASA 2007). Trade-off analysis is the set of techniques by which the “Best” solution is found for the customer weighing up cost, risk, effectiveness and other parameters. The weighting or importance of these parameters depends on the system goals and priorities, which are derived from stakeholder needs, which are gathered from stake-holders. As always good system solutions are derived from good systems engineering. Defining a decision framework that reflects competing goals, needs, priorities, parameters and architectures in a clear and understandable way. Orthogonal Variability Modeling (OVM) provides the ability to model systems and software products, their variation points, mutual exclusions, and product dependencies resulting in product lines. Through this modeling technique, fully sup-ported by the MBSE toolset, engineers can see their options and conflicts, (if any exists), and to pick their end desired product. Options can then be selected based on user goals, a configuration generated, and trade-off analysis can take place on the resulting model using analysis techniques such as simulation, comparison with physical systems and physics based analysis tools.
|
| Authors |
Michael Schoemaker and Brad Markisohn, Roche Diabetes Care
|
| Title |
The Agilization of Roche Diabetes Care
|
| Session |
Type: Invited
Theme: Agile Methods
Time: Wednesday May 01, 2019, 04:15 PM
Room: Ballroom 1
|
| Abstract |
Due to the high levels volatility in our environment, Roche Diabetes Care is taking the initiative to move from a traditional development model to Agile. While the initial focus is on R&D, changes are happening across the organization with many areas outside of R&D looking for ways to participate in agility. This talk will focus on:
• Factors driving change
• Our path towards agility
• Challenges and successes
|
| Authors |
Matthew Hause, PTC
|
| Title |
Decision-Driven Product Development
|
| Session |
Type: Submitted
Theme: MBSE
Time: Wednesday May 01, 2019, 04:15 PM
Room: Wright
|
| Abstract |
Product Line Engineering (PLE) is the engineering and management of a group of related products using a shared set of assets and a means of design and manufacturing. PLE can include system and software, assets and involves all aspects of engineering including electrical, electronic, mechanical, chemical, etc. PLE is normally considered after the product has evolved and complexity becomes too much to manage. Leveraging PLE from the very beginning will identify cost savings and commonality and provide a natural means for product evolution. Orthogonal Variability Modeling (OVM) provides a natural decision set allowing engineers to perform trade-offs for specific customers and guide system development along the most effective route. This paper will describe Model-based Product Line Engineering, the process for creating product lines, and the benefits of this approach. Finally, it will show how the adoption of MB-PLE early on in the development lifecycle provides more benefits without the potential disruption and re-engineering that can be involved when it is adopted later on in the lifecycle.
|
| Authors |
Dan Lyon, Synopsys
|
| Title |
A Primer on System Threat Modeling
|
| Session |
Type: Submitted
Theme: Cyber Security
Time: Wednesday May 01, 2019, 04:45 PM
Room: Ballrooom 2
|
| Abstract |
Threat modeling is an activity that is required to ensure systems are designed with security in mind, yet there are many different definitions for 'threat modeling'. This session will provide an overview of threat modeling methodologies as well as a deeper view of Synopsys' threat modeling methodology. Attendees will learn the importance why security is a systems problem and how to decompose a system into a security architecture that can be analyzed for potential weaknesses.
|
| Authors |
Michele Zoromski, m.zoro Consulting LLC
|
| Title |
Impact of Value Based HealthCare on the Medical Device Industry
|
| Session |
Type: Submitted
Theme: Healthcare Delivery
Time: Wednesday May 01, 2019, 04:45 PM
Room: Lindbergh
|
| Abstract |
Delivery of Care is quickly changing from a fee for service to fee for outcome known as Value Based Care. This will have an enormous impact on the medical device industry and the products that we develop, how we market, and how we sell.
More stakeholders (patient, physician, hospital, insurers, CMS, caregivers…) compels us to understand the real needs and values so that we can deliver products that provide the desired improved patient outcomes. It is truly a systems of systems challenge.
This presentation provides a look at the changing landscape. It includes actual case studies and industrial examples providing a lens into the impact of this change. We will discuss current strategies and tactics and future trends.
|
| Authors |
Steve Zielinski, Boston Scientific
|
| Title |
Machine Learning, Deep Learning - the Algorithms are the Sizzle, the Systems Engineering is the steak
|
| Session |
Type: Submitted
Theme: Systems - General
Time: Wednesday May 01, 2019, 04:45 PM
Room: Wright
|
| Abstract |
This presentation will focus on the role systems engineers play in the creation of AI/Machine Learning/Deep Learning systems. Machine learning models are becoming table stakes in the healthcare field. Are you ready? The headlines declaring the next advance in AI/Machine Learning/Deep Learning for healthcare are frequent and attention grabbing. The articles beneath the headlines typically focus on the architecture of the neural network that generated the results. What is frequently missing is a description of the system needed to generate the data, train the network, and evaluate the results. This presentation will cover some of the basics of machine learning and deep learning (neural network architectures, the back propagation algorithms) and then move on to describe the systems that must be in place to train, maintain, and evaluate the central algorithm. We'll discuss the role of systems engineers in constructing this ecosystem. We'll also talk about some of the cutting edge examples of AI/ML/DL in healthcare.
|
‹‹ Wed Morning Abstracts | Wed Afternoon Abstracts | Thu Morning Abstracts | Thu Afternoon Abstracts ››
For questions and comments, please contact:
Healthcare Working Group Program
Kelly Weyrauch