February 10-12, 2015  | Anaheim Convention Center | Anaheim, CA

2014 MD&M West Conference


Conference Track A: Design, Prototype & Usability

This track provides you with the most creative design thinking ideas to help bring your device to life with functional prototyping and 3D printing. Keep up to date with eHealth and consumerization trends and how to better integrate human factors engineering into your design process.

DAY 1 - Monday, February 10th
9:00 AM Keynote Address

The consumer electronics movement to the medical device space

Dr. Peter Tippett, Chief Medical Officer & VP of Innovation Incubator, Verizon Enterprise Solutions
9:50 AM Move to track
10:10 AM Chair’s opening remarks

Karl R. Leinsing, President, ATech Designs

Using design thinking methodology to discover creative solutions to your device development challenges

How you ask a question is as important as the question you ask. Too often, the result of a design exploration is hamstrung by the context in which it is considered. This workshop walks you through techniques to help you think unconventionally about your design challenges. You’ll discover methods for getting inspired by ideas outside of your domain, and how to apply that tangibly to your own development program.

Stacey Chang, Associate Partner and Director, Health and Wellness, IDEO
Brian Mason, Lead of Medical Products Group, IDEO

12:00 PM Lunch and Networking
1:00 PM Using software design to drive medical device differentiation
  • Using software and data management as a differentiator in a market where hardware is increasingly commoditized
  • Making the transition from hardware centric to software centric devices
  • Interoperability and connectivity – the need for systems and systems of systems approaches and thinking

Christopher Miles, Vice President, Consulting Services, Foliage

Using a customer value-centric perspective to exceed commercial expectations

Innovation occurs at the intersection of the customer’s rational expectations and their unimagined outcomes. Understanding tools and techniques that leverage your knowledge of customer perception and risk management can yield this result. But first you must develop an appreciation, understanding, and competency in value-translation techniques. This session will reveal a unique yet practical approach to product design innovation as a means to enhance your portfolio and pipeline opportunities. By combining interactive lecture and case studies with small group exercises, you will build and strengthen new capabilities to smooth the transition from ideas to innovations

John Crombie, Principal Engineer, Ethicon

2:30 PM Networking Coffee Break
Innovation beyond concept creation - Bringing medical devices to market

Role of innovation in creating new medical device concepts seems to be well appreciated. However, the ingenuity and innovation that it takes to enable these concepts to achieve functionality, reliability and manufacturability seems to be under-appreciated. Using examples from endovascular medical devices, this expert insight will be aimed at bringing an appreciation for the challenges faced in converting device concepts into commercialized products. Various stages in the product development and commercialization process will be discussed. Some of the current challenges in meeting unmet clinical needs will be mentioned.

Sanjay Shrivastava, Ph.D., Director, Global Marketing, Covidien

D3: Removing the toxic killers to healthy innovation?
  • Discussing the steps you need to take in the medical device product development process in order to ultimately deliver a high level of innovation in new product designs, and help ensure a successful launch
  • Reviewing what it takes to arrive at a truly creative idea, exploring the due diligence necessary to get there, and looking at how human factors engineering plays a role in this part of the development plan
  • Revealing some of the most common pitfalls that end up being innovation and creativity killers during new product development
  • Delving into right brain/left brain ideology and experimenting with activities that tie this thinking to innovation practices

Tom Kramer, President, Kablooe

4:30 PM Welcome Drinks Reception

DAY 2 - Tuesday, February 11th
9:00 AM Keynote Address
The entrepreneurial journey

Rudy Mazzochi, CEO, Elenza
9:50 AM Move to track
10:10 AM Chair’s opening remarks
Prototyping workshop – Building to Think

The traditional role of a prototype is to validate a design or an idea. This workshop will help you understand how prototyping can be employed as a tool for creative discovery, in addition to validation. In this workshop, learn how to answer critical development questions through a rapid prototype – you’ll develop your own prototype, and learn from it, in less than an hour.

Stacey Chang, Associate Partner and Director, Health and Wellness, IDEO
Brian Mason, Lead of Medical Products Group, IDEO

From making 1 prototype to manufacturing 1 million products: How to scale up your prototype

Hugh Ferguson, Director of New Product Development, Nonin Medical

11:50 AM Trends in 3-D Printing in Medical Technology

Michael Drues, Ph.D., President, Vascular Sciences

12:15 PM Lunch and Networking
3D printing at small length scales for medical device applications
  • Comparing rapid prototyping techniques used in medical devices and tissue engineering
  • Discussing direct vs indirect rapid prototyping
  • Exploring the current and future status of rapid prototyping in tissue engineering

Roger Narayan, Professor, Joint Department of Biomedical Engineering, North Carolina State University

Utilizing 3D printing in your design stages: Are you there yet?
  • Integrating 3D printing into your existing product development and design step up
  • Describing how this technology will impact the short term costing’s and material choice of your prototypes and end products?
  • Exploring the caveats of 3D printing use and integration and how these can be overcome

Greg Olsen, Industrial Design / User Experience

2:30 PM Networking Coffee Break
The next steps in rapid manufacturing
  • Exploring recent advances in rapid prototyping impacting manufacturing over the next 12 months
  • Advantages of using rapid prototyping methods versus rapid injection molding
  • Describing rapid prototyping technologies for rapid prototyping technologies for low volume production and prototypes

Bruce Bradshaw, Director of Marketing, Stratasys

3:45 PM Conference VIP Exhibition Tour: 3D Printing

Exclusive for conference delegates, join a guided tour on the trade show floor of the most innovative companies making waves in the 3D Printing industry

4:30 PM End of Day 2

DAY 3 - Wednesday, February 12th
9:00 AM Keynote Address

Yan Chow, Director of Innovation and Advanced Technology, Kaiser Permanente

9:50 AM Move to track
10:10 AM Chair's opening remarks

Tyler Blake, Ph.D., Principal and Chief Scientist, Human Factors Consulting Services, Inc.

From hospital to home: The switch from technical user to non-technical user

More now than ever, medical devices with various complexities are being put in the hands of the patient. What design considerations should be revised for this continuing trend? What are the limitations for this when conceiving new devices? Join a leading panel of 3 experts to discuss why getting feedback from the non-technical user is a crucial step in the design phase.

Andy Schaudt, Director of Usability Services, MedStar Health
Korey Johnson, Vice President, UX, GfK Custom Research, LLC
Ron Pierce, Vice President and Director of Design Strategy & Research, Karten Design

Beyond the basics of Human Factors Engineering 101
  • Reviewing human factor methodologies
  • Institutionalizing HFE into the product development
  • Getting management buy in and misspelling the myths of human factors

Andy Schaudt, Director, Medical Device Usability Division, National Center for Human Factors in Healthcare

12:00 PM Lunch and Networking
Interpreting requirements for Human Factors validation testing
  • Exploring the similarities and differences between traditional formative or summative usability testing and human factors validation for regulatory approval
  • Evaluating the factors to consider when deciding on your sample size
  • Understanding the relationship between risk analyses, formative testing, and human factors validation
  • Exploring whether or not to train participants in a human factors validation test and how to get the most out of human factors research while minimizing cost.

Korey Johnson, Vice President, UX, GfK Custom Research, LLC

A Broad View of Human Factors: Discovering Physical, Cognitive, and Emotional Needs

Exploratory research is an important first step for establishing the priorities and goals that will lead to a successful human factors outcome. Learn strategies for leveraging the exploratory phase to develop deep empathy for the physical, cognitive, and emotional needs of patients and clinicians.

Ron Pierce, Vice President and Director of Design Strategy & Research, Karten Design

2:30 PM Networking Coffee Break
Human factors in risk management

Properly identifying and mitigating use-related hazards is an important step in designing medical products. In this session, participants will learn how to incorporate risk management activities into their human factors planning. Topics include:
  • How IEC 62366 and ANSI/AAMI HE75 relate to risk management
  • Managing Use-Risk across the product lifecycle
  • Identifying critical tasks for testing
  • Evaluating failures, close calls

Pat Baird, Principal Systems Engineer, Baxter Healthcare
Mike Rakauskas, Human Factors Engineer, Baxter Healthcare

The business case for Human Factors

  • Selling Human Factors to the Human Factors challenged
  • Reviewing practical methods to overcome common human factors myths
  • Presenting the opportunities where the academic side of human factors can significantly improve product build and sale

Pat Baird, Principal Systems Engineer, Baxter Healthcare
Mike Rakauskas, Human Factors Engineer, Baxter Healthcare

4:30 PM End of Day 3

DAY 4 - Thursday, February 13th
9:00 AM Keynote address
Building devices in a big data world

Shahid Shah, CEO, Netspective Communications but better known as the “The Healthcare IT Guy”

9:50 AM Move to track
10:10 AM Chair’s opening remarks
The continuing rise of mHealth

  • What is The Future growth of the mhealth market, adoption rates, and integration capabilities with HCIT products and detailing the key barriers of implementing mHealth?
  • An overview of the state of mhealth regarding the adoption of mobile healthcare apps, devices, and solutions
  • What are the adoption trends of mhealth initiatives around the world by type e.g. telemedicine, patient monitoring, call centers, etc.
  • Discussing the economic potential of mhealth for elderly care costs, data collection costs, rural healthcare reach, and maternal/pre-natal mortality rates reduction
  • What is the Perception of how mHealth can benefit the healthcare industry in improving quality of care, managing chronic diseases, and reducing costs, etc.
  • What are the Key barriers of implementing mHealth?

Mark R. Anderson, FHIMSS, CPHIMS , CEO, AC Group

New technologies driving patient empowerment

The phenomenal trajectory of mHealth, wireless, and traditional medical devices is revealing broad new opportunities to diagnose, manage and treat patients. This evolution is occurring at the same time that the Affordable Care Act is forcing healthcare organizations to adopt new methodologies to care for those patients. Grounded in the realization that patients must engage in their own care to create sustainable change, patient empowerment is at the confluence of these technology and care revolutions.

Russ Rymut, Product Manager for LifeCare, Honeywell

11:30 AM FDA - Getting the Green Light

Working with the FDA is not difficult regarding Mobile Devices if you follow their guidelines and requirements which are published and public. Know your intended uses, target market (OTC or Rx), product claims, and if you don't have previous experience, seek professional outside guidance.

Lee B. Ehrlichman., Executive Vice President, Special Projects and Healthcare Compliance Officer, LifeWatch Services, Inc

12:15 PM Lunch and Networking
1:00 PM

Wireless Medical Device 510(k)s updates

  • FDA Guidance: Radio-Frequency Wireless Technology in Medical Devices; 8/14/2013
  • Exploring FDA Wireless concerns and FCC requirements
  • Discussing Wireless testing plans
Eben Gordon, Senior Director, Regulatory, Sotera Wireless

1:40 PM

Seamlessly integrating intravenous infusion devices with hospital information systems: Providing vital patient information safety and securely

This presentation will provide a case study insight into how wireless medical devices have been successfully implemented across a hospital’s wireless network. You will hear first-hand about the challenges in implementing the project, the key steps that needed to be taken to put the process into action and the end result – transformation in the delivery of vital patient information. Topics covered include:

  • Best practice approaches and lessons learned
  • Establishing wireless connectivity across the hospital’s complex network: ensuring safety and secure information delivery
  • Current challenges and what is next for product development?
Robert Schad, Technology Operations & Marketing Leader, CareFusion

Wireless technology in a hospital setting: Cutting the cord
  • Covering technologies that address issues from asset management to patient safety
  • Discussing how mobile devices can improve process flow and efficiency
  • Addressing privacy concerns with wireless technologies
  • Discussing related regulatory issues

Stephanie Kreml, MD, Principal, Popper and Company

2:50 PM Networking Coffee Break
3:15 PM Overcoming the present and future constraints of wireless medical device technology
  • Looking at how all networkable devices, including medical devices use the internet to achieve a number of functions
  • Shifting standards: Network providers are not providing a homogeneous infrastructure solution or best practices guides. What to medical device manufactures have to do work in a dynamic environment especially when the lead time for a medical device can be as long as 5 years?
  • Detailing the who, what and how of networking standards needed to best leverage the available technology

Jeffrey Johnson, CISSP, Solution Engineering Manager, Hospira

3:50 PM Security concerns of network connected medical devices
  • Detailing the common protocols (wired and wireless) rapidly gaining traction in health care
  • Discovering vulnerabilities in protocol implementations and applications used in medical devices and networks (including real statistics)
  • The FDA’s most recent approach and position on cybersecurity of connected medical devices
  • What medical device manufacturers, health care providers, and working groups are doing to address security concerns

Mike Ahmadi, Global Director, Medical Security, Codenomicon

4:30 PM End of Conference
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