Medical Design & Manufacturing East Conference

Monday, June 9th

<Agenda Overview Next day's Agenda>
9:00 Keynote address
Creating a Sustainable Innovation Pipeline in the Evolving Medical Device Sector
Scott P. Bruder, MD, PhD, Vice President, Chief Medical and Scientific Officer, Stryker Corporation
  Designing Next-Gen Medical Devices Regulatory Report: Keeping Your Finger on the Pulse Smart Sourcing and Supplier Management
9:50 Morning break and move to track
10:15 Disruptive versus evolutionary innovations: Challenging accepted rules to have that Eureka moment
  • What defines disruptive innovation and how can you embed it into your day-to-day?
  • Discussing opportunities to innovate for value-based healthcare systems
  • Making sure you have room to innovate on your current projects
  • Exploring ways to gain support for your disruptive innovations

Ruth Cheng, Director of Innovation, Smith & Nephew

Latest developments and practical implementation of adopting the revised European Medical Device Directive
  • Scope clarification to ensure all medical devices are correctly classified and assessed for safety and efficacy.
  • Clarification of rules, rights, and responsibilities for authorized representative, manufactures, importers, and distributors.
  • A requirement for device manufacturers and the EU reps to retain "qualified persons" with at least 5-years of regulatory experience.
  • Adaption of rules to promote applicable safety and performance requirements for new technologies, including software.
  • Improved coordination between national authorities to ensure that only medical devices that are safe and effective are placed and retaining in the EU marketplace.
  • Unannounced inspections/audits by notified bodies

Christopher J. Devine, Ph.D., President, Devine Guidance International

Understanding the potential and different dynamics of outsourcing in the BRIC countries
  • Gaining a greater insight into the current and future trends of outsourcing to the BRIC markets
  • What will the BRIC offshoring market look like in 5 years?
  • Exploring the advantages and disadvantages of moving from China to South America and Mexico
  • Ensuring both product quality and regulatory compliance
  • Determining key difference between local regulations, distribution networks and workforce skills

Julia Wall, Analyst, Analyst, Decision Resources Group
Shriram Venkataramana, Medtech Insights Manager, Decision Resources Group

10:45 How can Western medical device component manufacturers sell to Asian medical device manufacturers
  • Which are the best Asian countries to sell your components?
  • Discussing best ways to determine which Asian device companies to approach
  • Understanding what you need to know about Asian medical device companies

Ames Gross, President, Pacific Bridge Medical

11:15 Deep miniaturization case study of breakthrough innovation in shrinking medical devices
  • History of size reduction and technology in implantable active medical device products
  • How cross-functional design and manufacturing led to the world's smallest cardiac devices
  • The future applications of this enabling technology to optimize global healthcare resources

Mark Phelps, Senior Program Director, Diagnostics and Monitoring, Medtronic

Medical device registration and approval in Japan, India and China: Preparing the changes required for 2014

Ames Gross, President, Pacific Bridge Medical

  • Assessing how the PAL Reform Act is changing premarket submissions, certifications and approvals
  • Discussing what the short term and long term impacts of the regulatory reforms will be
  • Exploring the greater focus on safety and quality management systems

Ames Gross, President, Pacific Bridge Medical

Medtech outsourcing: How to benefit from accelerating M&A markets
  • Exploring industry dynamics and consolidation drivers
  • M&A scorecard: how do you rate versus what investors seek
  • Discussing how to manage risks, process pitfalls and action plans
  • Assessing cultural and strategic fit

Eric Williams, Managing Director, Capstone Partners

12:00 Complimentary Catered Lunch for Conference Attendees,
Plus a Lunch & Learn on Dual-Wall Heat Shrink Tubing is open to all, and is hosted by TE Connectivity
1:00 Intelligent implant designs: Improving sensors for device efficiency

Sridhar Iyengar, Co-Founder and Chief Technology Officer, Misfit Wearables

Insight: FDA's Review & Classification of Medical Device Recalls

William C. Macfarland, Supervisory Biomedical Engineer
Jessica Paulsen, Biomedical Engineer
Daniel Dill, Program Analyst Division of Manufacturing Quality (DMQ) Recall Group, Office of Compliance, FDA

(1:30) Best practices in interacting, communicating and negotiating with the FDA

  • When are we required to communicate with FDA? When should we? Is it ever to early?
  • What should we say and how should we say it? What should we say not and how should we not say it?
  • Who should communicate with FDA and who should not? When verbally and when in writing?
  • When should we communicate formally and when informally?
  • How do we avoid timely and costly mistakes and how can we use creative ways to use communication with FDA to our advantage!

Michael Drues, PhD, President, Vascular Sciences

Developing a timeline for implementation and preparing for an effective response
  • Best practices in responding to FDA's form 483 observations
  • Promptly responding to warning letters and identifying the appropriate course of action
  • Developing a timeline for implementation and preparing for an effective response

Michael Drues, PhD, President, Vascular Sciences

Supplier Quality: Enforcing more stringent compliance
  • How is supplier quality becoming more complex?
  • Learning from past mistakes and the most common pitfalls in supplier quality management
  • Detailing best practices in supplier quality audit plans
  • Focusing on the areas of greatest risk by developing concrete plans to mitigate risk

Ravi Nabar, Senior Director, Supplier Quality Management, Philips Healthcare

1:45 Using a customer value-centric perspective to dissect customer expectations and transform them 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, Co-Founder, UpStart Product Development LLC

Exploring the significant chances of Notified Bodies unannounced audits

Where outsourced components are used, the end-equipment manufacturer's risk mitigation (supplier controls) must be "commensurate with the risk". Regulators are now focusing their attention on the supply chain, as evidenced by the EU's Commission Recommendation 2013/473/EU which states in part: "Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer's critical subcontractors or crucial suppliers if this is likely to ensure more efficient control". Are you prepared? Will your processes support Regulators expectations and increased scrutiny? This presentation explores risk management and supplier controls, and what may be needed to ensure safe and effective devices in the marketplace, as well as regulatory expectations.

Mark Leimbeck, Program Manager Medical Regulatory Advisory Services, UL

2:30 Afternoon break

Panel Discussion: Novel designs and medical devices brought to you by the MDEA finalists

Join 3 MDEA finalists who will present their award nominated technologies and discuss how they overcame the main challenges of getting their device from concept to market.

John Kelly, Chief Executive Officer, Atomo Diagnostics
Moji Ghodoussi, Marketing Director, Remote Presence Devices and OEM partners, InTouch Health
Keith Carlton, R&D Director, Boston Scientific
John Naybour, Marketing Manager, DePuy Synthes

Bringing clarity to the 510(k) modifications and IDE approval processes
  • Understanding the FDA's current 510(k) modifications document and the standard
  • Knowing FDA's current thinking reflected by the 510(k) modifications guidance forcibly withdrawn under FDASIA
  • Reviewing IDE requirements and discussing how study design and site selection play a part in speed to market
  • Determining what must be included in an IDE application

Megan M. Shackelford, Consultant, Medical Devices, Biologics Consulting Group (Former FDA Scientific Reviewer)

Exploring 5 ways to control supplier costs
  • When should cost become a factor in choosing a supplier and how do you deal with an increase in supplier pricing?
  • Exploring how to renegotiate your supplier contracts on an annual basis

Victor Morris, Project Manager, Supplier & Internal Audit Program, Integra LifeSciences

3:45 (3:30) WORSKHOP
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
Brian Mullins, Senior Design Manager, Kablooe

Common pitfalls of UDI implementation and how to avoid them
  • How UDI implementation is similar to, and also different from, other projects
  • Achieving management commitment to ensure project success
  • How choosing the right implementation team can ensure sustainability of the process after the project ends

Debara R. Reese, Vice President, Quality and Compliance, Maetrics

Protecting your Intellectual Property (IP) when working with your suppliers
  • Conducting Intellectual Property due diligence and protection strategies for large and small companies
  • Gaining insight into foreign filing considerations, licensing and distribution
  • Updates on technology confidentiality and branding strategies

David J. Dykeman, Patent Attorney & Shareholder, Greenberg Traurig LLP
Roman Fayerberg, Patent Attorney, Greenberg Traurig LLP

4:30 Welcome drinks reception

<Agenda Overview Next day's Agenda>



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