Medical Design & Manufacturing East Conference

Tuesday, June 10th

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9:00 Keynote address
IBM Watson: A true healthcare game changer
Eric W. Brown, Ph.D., Director, Watson Technologies, IBM
  Advances in Interoperability and Integration in eHealth

Dr. Liam Pender, President and CEO, Egret Technologies

Simplifying Risk Management and Quality Control Devising Scale-up Strategies and Manufacturing Technologies to Reduce Costs and Minimize Waste
9:50 Morning break and move to track
Regulatory mobile medical devices: Overcoming local and global challenges
  • Discussing any critical changes in global wireless regulations
  • Understanding what role the FCC plays in the regulatory approval of wireless devices in partnership with FDA
  • How are mobile medical applications being handled at the regulatory level?
  • Discussing the Radio Frequency Wireless Technology guidance and its impact over the next 12 months worldwide
  • Harmonizing US and global wireless regulations

Keith A. Barritt, Principal, Fish & Richardson P.C.
Terry G. Mahn, Principal, Fish & Richardson P.C.
Fish & Richardson

Interoperability in a hospital setting: Cutting the cord
  • Open questions to the manufacturers from the hospital viewpoint: What are hospital’s main concerns when it comes to integrating wireless devices and supporting existing legacy devices?
  • Uncovering the challenges that hospitals have when supporting wireless devices from multiple manufacturers
  • What are hospital institutions looking for in an interoperable system?

Ken Fuchs, Executive VP - Interoperability R&D, Center for Medical Interoperability

(11:40) Interoperability in healthcare
  • What is interoperability
  • Value of Healthcare Information Exchange and Interoperability
  • Healthcare interoperability standards
  • Role of providers, payers and vendors
  • How accountable care and meaningful use regulatory requirements are shaping up interoperability in healthcare
  • Case study: Transfer of Care
  • Future vision

Nias Puthenveettil, Director of Technology,
Siemens Healthcare

Selection of SAL for a terminally sterilized product
  • Discussing the historical perspective on SAL
  • What impact can 10-6 SAL have on innovation?
  • Exploring ST67 concepts
  • Selection of SAL based on surgical site infections

Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs
Nelson Labs

(10:45) Evaluation of "less-than" values in bioburden data
  • When are less-than values used?
  • Addressing potential issues with use of less-than values – particularly in radiation sterilization
  • Determining options for reducing less-than values
  • Calculating a more true value when using less-than numbers

Martell Winters, B.S., RM/SM(NRCM), Senior Scientist, Nelson Labs
Nelson Labs

(11:15) Setting Alert and Action Levels for Product and Environmental Bioburden Counts
  • Exploring The Normal Distribution
  • What should be done at alert and action levels? What should not be done?
  • Establishing alert and action levels for various sterilization methods
  • What is a bioburden spike? An option based on normality/abnormality of the data.

Martell Winters, B.S., RM/SM (NRCM), Senior Scientist, Nelson Labs
Nelson Labs

Applying design for manufacturing principles starting at the concept stage
  • Building your manufacturing line in the early design and development phase
  • Balancing robust processes, cost, and schedule for new manufacturing technology implementations to meet launch and production requirements
  • Addressing challenges in automating processes
  • Scale-up efficiency and guaranteeing a sustainable supply at acceptable quality levels as manufacturing scales-up

Kent Mosier, Senior Director of Engineering, Integra LifeSciences

Best practices in cost control in medical device manufacturing to maximize productivity
  • Exploring how to reduce manufacturing costs outside offshoring and outsourcing
  • Discussing new software and IT options to provide better operational and manufacturing solutions
  • Understanding how the switch to paperless data management can cut costs

Keith Roberts, VP of Operations, Svelte Medical

12:00 Complimentary Catered Lunch for Conference Attendees
1:00 Addressing data security concerns of wireless medical devices from a manufacturer's perspective
  • Determining how to ensure secure data transfer between local and remote servers
  • How can you safeguard data security through product development?
  • EHRs could influence product development, quality and design decisions

Steve Abrahamson, Director Product Security Engineering, GE Healthcare

Risk management for gamma radiation sterilization
  • Considerations for choosing gamma sterilization for medical devices
  • Validation of the gamma sterilization process following ANSI/AAMI/ISO 11137-1
  • Methods of using FDA-recognized ASTM Standards for Dosimetry in Radiation Processing as part of process validation
  • What is the regulatory responsibility of medical device manufacturers in gamma sterilization process validation

Carlo Coppola, Associate Director, Gamma Center of Excellence (GCE), Nordion

Key methods in how to identify waste and find inefficiencies
  • Applying lean principles and applications to manufacturing medical devices
  • Effectively working with your suppliers and partners to reach the same goals in reducing costs but keeping consistent quality
  • Re-evaluating your inventory and improving your material flow
  • Refining your assembly and production systems

Paul Daly, Senior Manufacturing Manager, Haemonetics

1:45 Addressing Medical Device Security Risk

Networked medical devices and other mobile health (mHealth) technologies have the potential to play a transformational role in health care but also may be a vehicle that exposes patients and health care organizations to safety and security risks. In addition, the regulatory environment has also adapted to address these risks: FDA Cybersecurity Guidance, HIPAA Privacy & Security Regulations, and other national and regional privacy regulations. In order for medical device manufacturers to create innovative, yet patient safe devices, while creating and preserving value for their shareholders, they will need to become better at building secure medical devices from the ground up. This talk will discuss the principles and drivers of medical device security risk and how this risk can be comprehensively addressed by medical device manufacturers.

Geoffrey A. Pascoe, Specialist Master, Deloitte

Building a shatterproof CAPA system: It does exist!
  • Building the right foundation for a successful CAPA program
  • How to make your quality system integral to CAPA
  • Common mistakes that cause a CAPA program to fail

Andrew Harrison, Vice President & General Counsel, RCA

A focus on operational excellence to exceed medical device manufacturing demands and business results
  • Overcoming the challenges of implementing an effective operational excellence program in a regulated manufacturing environment
  • Detailing case studies and solutions on the most efficient manufacturing OpEx programs
  • Examining the difficulties of getting your business on board

Sudhakar Varshney, Vice President, Global Engineering & Continuous Improvement, Haemonetics

2:30 Afternoon break
3:00 The other side of wireless: Connecting wireless devices with mobile apps and cloud computing
  • Detailing the engineering challenges and risks of integrating external software with wireless medical devices
  • Best practices to shorten regulatory submission cycles
  • Applying new technologies (wireless, mobile, cloud computing and big data) to enable improved outcomes

Bernhard Kappe, President, Pathfinder

(3:00 – 5:00pm)
Workshop: A deeper drill into risk management
  • Laws, Regulations, Guidance, Standards related to Risk Management and Medical Devices – Jeremy Jensen
  • Risk Management and Software – What works and what doesn't – Dave Vogel
  • Differences in Risk Management for Medical Device Software and Non-Device Software – Jeremy Jensen
  • Risk Management and Software Validation: How one complements the other. – David Vogel

David Vogel, Ph.D., Founder and President, Intertech Engineering Associates Inc.
Jeremy Jensen, Quality System consultant, Boston Scientific

New developments in laser micro-machining for medical devices
  • Detailing the advancements in laser micro-machining for cutting, milling and drilling
  • Discussing any future novel applications in 3D structuring and large area machining for manufacturing
  • Exploring the potentials of using laser micromachining for MEMs production

David Gillen, PhD., Managing Director, Blueacre Technology

3:45 Wireless testing requirements: Product interoperability and product testing

Mark Ryan, Senior EMC Engineer, TÜV Rheinland

  Innovative applications for molded interconnected devices MID technology
  • Integrating MID technology into an injection molded device
  • Optimizing this technology for miniaturization to combine mechanical and electronic functions into a single component
  • Exploring how MID technology influences rapid prototyping and process manufacturing

Malte Fengler, Process Engineering LDS Technology, LPKF

4:30 End of day 2 conference

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