2013 Master Classes Agenda

Master class 1 - Monday, October 28 - AM
Start-up Accelerator
10:15 AM Chair’s opening remarks

Allan Daisley, Director of Entrepreneurship and Sustainability, Memphis Bioworks

10:20 AM From Zero to 510(k) for startups – Medical Device Acceleration

In this session we'll look in detail at one method of accelerating medical device start-ups through the start-up process: A medical device accelerator focused on the 510(K) route to market. We'll explore some of the experiences and insights gained from running a first-of-its-kind medical device accelerator: what worked, what didn't, and some of the great lessons learned from spending quality time in the trenches with a wide range of entrepreneurs.

Allan Daisley, Director of Entrepreneurship and Sustainability, Memphis Bioworks

11:00 AM Requirements for reimbursements

Michael Sanchez, Founder and Principal Advisor, Pivotal Reimbursement Consulting

11:40 AM Acquisition strategies
  • Focusing on real-life M&A successful medical device case studies and why they continue to work in the long term
  • Combining a real time desire of several strategic buyers who are actively acquiring medical related companies today eg component manufacturers like needs, plastics, tubing, injection molders, to proprietary product manufacturers, to medical packaging companies

Matt Bradbury, Managing Director, Business Acquisition & Merger Associates

12:30 PM End of masterclass

Master class 2 - Monday, October 28 - PM
Supplier Management
2:00 PM Chair’s opening remarks
2:05 PM Building a successful supplier-manufacturer relationship
  • Establishing robust criteria to align supplier capabilities with business needs
  • Reviewing how regulatory requirements are changing and the implications for supplier relationships
  • Developing models that promote suppliers as key strategic partners in product development and accommodate longer term partnering

Jason Hoopman, Principal Consultant, Hoopman Consulting

2:45 PM Supplier quality controls: The details
  • What is a supplier control and why do we follow it?
  • Understanding the need for stringent supplier controls for patient safety and to follow required regulations to mitigate risks

Thomas Ebertowski, Director Global Supplier, Quality Assurance at the Boston Scientific

3:30 PM Manufacturing, outsourcing strategy, decisions and management

Customer and financial stakeholder requirements are rapidly changing in today’s global business environment. Organizational response to changing market demands is more critical today than ever. The global economy has increased pressure on organizations to optimize quality and value in delivery of products to customers. Successful companies optimize the allocation of resources between insource of core competencies and outsourcing to add value and flexibility to supply chains.
The decision to outsource is a process, not a destination. The core message in the presentation is to understand the processes required to drive sound sourcing decisions that increase value for customers, the organizational connections required for management of business and quality performance with outsource partners.

Jack Sandahl, Fellow Commodity Specialist, CRM Supplier & Materials Management at the Boston Scientific

4:15 PM

Effective supply chain management for medical devices

Supply Chain professionals are often asked to “build the plane while flying.” Companies must deliver quality products and services, respond to changing regulatory requirements, and manage increasingly complex supply chains -- all while growing the bottom line. To achieve these goals requires breakthrough transformation and the simultaneous reengineering of people, process, and tools.
Companies are grappling with managing these challenges; to date, there have been more failures than successes. This presentation focuses on how to overcome the pitfalls of implementing transformational supply chain strategies and how to capitalize on the high-impact opportunities.

Thaddeus Agar, Director, Global Strategic Programs, Supply Chain, Healthcare, Ecolab

5:00 PM End of masterclass

Master class 3 - Tuesday, October 29 - AM
Wireless and Mobile Technology in Medical Devices
10:15 AM Chair’s opening remarks

Michael Nowak, RF & Wireless Consultant, Multi Tech Systems

10:20 AM Where are the future opportunities in wireless and mobile health applications
  • Exploring the opportunities in wireless and wearable devices and what this means to the manufacturer
  • Overcoming challenges associated with integrating wireless technology into an existing products
  • Measuring health outcomes for consumer healthcare devices

Mark VanderWerf, VP eHealth, Nonin Medical

11:00 AM FCC initiatives to encourage mHealth innovation

Matt Quinn, Director of Healthcare Initiatives, FCC

11:40 AM Connecting medical devices to Smart Phones - tips and tricks for using Bluetooth Smart

With support in Android and Apple devices as well as cheap coin cell powered electronics, Bluetooth Smart is becoming the technology of choice for connected devices. The class will focus on the issues that medical device and app designers should be aware of when attempting to connect medical devices to smart phones.

Dr. Robert Milner, Senior Consultant, Cambridge Consultants

12:20 PM Exploring methods for managing risk within design and usability

Describing three layers of testing to ensure the wireless features of our device work in customer's networks.
Essentially, there is no way in a lab setting that you will be able to emulate the complexity of an active hospital network. So, this presentation will take an approach that involves these three layers including internal lab testing, external facility and interoperability testing.

Scott Wiese, Lead Systems Engineer – Mobile X-Ray, GE Healthcare

1:00 PM mHealth and the Implanted Device
  • Discussing the current state of wireless and internet connectivity with implanted devices (both cardiac and diabetes pumps)
  • What opportunities and challenges lie ahead with the emerging mHealth ecosystem?

Paul Krause, Leader & Technical Fellow, Connectivity Systems Engineering, Medtronic

1:40 PM End of masterclass

Master class 4 - Tuesday, October 29 - PM
Medical Device Sterilization and Testing Solutions
2:00 PM Chair’s opening remarks

Robert Reich, CEO, Lexamed

2:05 PM Addressing sterilization requirements during product design

Todd Powell, Sterility and Assurance Manager, Bayer Healthcare

2:45 PM Best practices in sterilizing and cleaning reusable medical devices

The presentation will focus on challenges associated with cleaning and disinfection validation studies for reusable medical devices compliant with the 2011 FDA Draft Guidance Document. Design and execution of studies has highlighted a number of issues associated with both semi-critical and non-critical medical devices as well as with FDA-approved high level disinfectants and EPA-approved intermediate level disinfectants. A number of specific examples and a case study will be presented to highlight these challenges. Strategies to address the issues will also be presented.

Robert Reich, CEO, Lexamed

3:30 PM Reviewing industrial Ethylene Oxide Sterilization for Medical Devices

Doug Harbrecht, President, Sterility Assurance

4:15 PM Sterilization validation methods

Jason Hedrick, Senior Principal Sterilization Specialist, Medtronic

5:00 PM End of masterclass

Master class 5 - Wednesday, October 30 - AM
Power Management
10:15 AM Chair’s opening remarks

Michael Root, Fellow, Boston Scientific

10:20 AM Market trends, opportunities, and challenges for implantable and portable medical device batteries

There is great opportunity for the future of portable and implantable medical device batteries. New developments in rechargeable and primary cell systems enable increased run time and greater longevity. OEMs are manufacturing smaller devices while demanding more power, enhanced functionality, increased safety, MRI compatibility and sterilization. With the proliferation of batteries in medical devices and a wider array of different battery types in the field, the challenge is to assure that these batteries can meet the unique requirements of each application, and that they perform with the reliability and safety that is expected for critical medical applications.

Robert Rubino, Senior Manager R&D, Greatbatch Medical

11:00 AM Performance and Reliability Evaluation of Implantable Medical Device Batteries

Implantable medical devices serve important functions in modern health care. They help patients manage or even survive certain medical conditions. Primary (nonrechargeable) or rechargeable batteries power a wide variety of implantable therapeutic and diagnostic devices, including cardiac pacemakers and defibrillators, spinal cord neurostimulators for pain management, drug pumps, heart monitors and hearing devices. Reliability and longevity, then, are key considerations when designing, developing and manufacturing batteries for these devices, particularly for life sustaining devices like implantable pacemakers and defibrillators. Discussion will center on:
  • The need for reliable, long-lived medical device batteries
  • Reliability and performance battery testing
  • Battery modeling for longevity prediction

Michael Root, Fellow, Boston Scientific

11:45 AM Considerations for Design and Selection of Power Sources for Implantable Devices

Dr. Gaurav Jain, Senior Research Manager, Battery Research Group, Medtronic

12:30 PM End of masterclass

Master class 6 - Wednesday, October 30 - PM
Medical Device Coatings
2:00 PM Chair’s opening remarks

Stacey Bremer, Business Unit Manager, New Technologies, Harland Medical

2:15 PM Developments in antimicrobial coatings

As healthcare-associated infections (HAIs) increase and continue to pose a challenge to hospitals and healthcare facilities, providers are tasked with improving patient health while reducing the risk of infection.
  • Exploring recent breakthroughs in parylene coating technologies
  • Discussing how this new technology can be applied to a variety of medical devices and applications to effectively eliminate microorganisms

Dr. Rakesh Kumar, Vice President Technology, Specialty Coatings Systems

3:00 PM Antifouling Graft Polymer Design of Coatings for Biomedical Devices

Implantable medical devices carry the risk of foreign body reaction and infection. Proteins adsorb to the surface and set the stage for fibroblast and macrophage colonization, conversion to giant polynuclear cells, and fibrous capsule formation. Infection proceeds by bacterial colonization and laying down of a matrix. Fouling resistant coatings of hyaluronic acid (HA are difficult to maintain. We address this problem with a slowly biodegradable coating consisting of polycapraprolactone (PCL), into which a small fraction (< 3%) of nanoparticles, consisting of PCL chains grafter to a HA main chain, are incorporated. These polymers renew their antifouling outer layer as they degrade, and are promising as substrates and coatings for medical devices.

Professor Ronald A. Siegel, Professor of Pharmaceutics and Biomedical Engineering, University of Minnesota

3:45 PM Case study: Next generation coating technology

Professor Thomas Webster, Department Chair and Professor of Chemical Engineering, Northeastern University

4:30 PM PANEL DISCUSSION: Challenges in characterization of medical device coatings

Dr. Rakesh Kumar, VP Technology, Specialty Coatings Systems
Professor Ronald A. Siegel, Professor of Pharmaceutics and Biomedical Engineering, University of Minnesota
Professor Thomas Webster, Department Chair and Professor of Chemical Engineering, Northeastern University

5:00 PM End of masterclass
© UBM 2013. The program is subject to change without notice. UBM reserves the right to alter venue, speakers and/or content.

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