Program

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October 18, 2022

* JOIN US FOR THE PRE-EVENT HAPPY HOUR on October 17, 2022 FROM 6:00 PM – 7:00 PM

7:00 am – 7:55 am CST

Delegate Registration and Networking Breakfast

8:00 am – 8:10 am CST

Chair's Welcome and Opening Remarks

Design

Nina Goodheart

SVP and President, Structural Heart and Aortic
Medtronic

Product Development

Nicole Young

Director, R&D Program Management, Core Diagnostics, IACC
Abbott

Quality & Regulatory

Jody Powell

VP, Regulatory Affairs, Quality Assurance & Clinical
Stryker

Innovation

Alind Sahay

VP, Research & Development
Pentax Medical

8:10 am – 8:45 am CST

Opening Keynote

Steve C de Baca

EVP, Quality and Regulatory Affairs Enterprise
Cardinal Health

Defining Your Competitive Edge Through Collaboration and Integration

  • Uncovering the latest technologies that improve speed-to-manufacturability while exceeding clinical and regulatory standards in the medical or invitro diagnostic (IVD) device industry
  • Using urgency and agility to fuel device development and authorization
  • A deep dive into Cardinal Health's transformative journey
  • Case study: Looking back on the role that the coronavirus pandemic played in reshaping industry operations: rise in telehealth, managing third party relationships, and addressing regulatory changes and challenges
View More

available:  Slides |  Video

8:45 am – 9:20 am CST

Plenary

Jolanta Zadlo

Director, Program Management Business Model Transformation
GE Healthcare

CREATING A DEVICE-ENABLED DIGITAL ECOSYSTEM FOR BREAKTHROUGH PATIENT OUTCOMES

  • Discussing the key drivers for digital transformation
  • Driving “Product + Service + Edison artificial intelligence platform” based business model transformation and go-to-market strategy across GE Healthcare
  • Examining the roadmap to your device-enabled digital ecosystem
  • Leveraging devices to create unique data and identify unique opportunities to drive patient outcomes
  • Effectively tackling pressing challenges and counterbalancing the bottom line to scale your digital operations
9:20 am – 9:55 am CST

Plenary

Kamel Alzarka

Chairman and Founder
Falcon Group

Building Medical Device Supply Chain Resilience

  • Industry update
  • Achieving effective collaboration: third party inventory ownership and Asset-as-a-Service solutions
  • Leveraging existing commercial terms with suppliers while improving balance sheet efficiency
  • Lessons learned from COVID-19 pandemic supply chain disruptions
  • Innovative methods for mitigating future challenges
  • Identifying vulnerabilities along the supply chain lifecycle
View More

available:  Slides |  Video

10:00 am – 11:40 am CST

Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings

11:45 am – 12:20 pm CST

Sessions

Design

Victoria E. Carr-Brendel, Ph.D.

GVP, Cochlear Implants and President
Advanced Bionics at Sonova

DEVICE TALK: POWERING THE FUTURE OF PRODUCT DEVELOPMENT

  • Leveraging technology transformation for cochlear implant design and development
  • Tips and tricks for getting first-to-market
  • Discussing the value of bluetooth-enables devices: CI sound processors designed for children
  • Ensuring design and manufacturing process transparency
View More

available:  Slides |  Video

Product Development

Vinay Malur

Director, Program Management
Intuitive

From Good to Exceptional: How to build and sustain a successful R&D Organization

  • Mind mapping what a successful R&D organization looks like: Tools, Tech, and Teams
  • How can you find opportunities to lower costs, shorten timelines, and add agility to your work
  • Addressing shorter timelines
  • How to lead and retain high-performing global talent and teams
  • Building a culture of ownership and transparency: Goal planning and review practices
View More

available:  Slides |  Video

Quality & Regulatory

Khaudeja Bano, M.D.

VP, Combination Product Quality
Amgen

Executing Post Market Requirements for Combination Products

  • Enhancing organizational effectiveness in combined pharmaceutical and device vigilance
  • What is expected from medical device regulators when it comes to risk management and how the device is being used?
  • Feedback on DDCP companies related to handling PMS
  • Why risk management is key to the post market phase of lifecycle management
  • Future thoughts: What's next in post market safety?
View More

available:  Slides |  Video

Innovation

Nitya Narayanan

Senior Director, Regulatory Affairs
Bigfoot Biomedical

A ROADMAP FOR LEADING REGULATORY COMPLIANCE AND QUALITY PROCESSES

  • Developing innovative insulin delivery products for people with type-1 and type-2 diabetes
  • Streamlining production, inventory, and increasing speed-to-market without compromising on quality
  • Overviewing tips and success stories to achieve our 510k FDA clearance for the Bigfoot Unity™ System, which features connected smart pen caps for disposable insulin pens that recommend doses for people relying on multiple daily injection therapy
View More

available:  Slides |  Video

12:25 pm – 1:00 pm CST

Workshops

Design

Jackie Leslie

Category Specialist Life Sciences
Esko

Reduce Risk & Gain Efficiencies in Artwork & Labeling with Digital Transformation

  • Learn how technology can streamline artwork and labeling processes
  • Reimagine the change process with content re-use, automation and rules-based processing
  • Achieve End-to-End visibility with integration
View More

available:  Slides |  Video

Product Development

Justin Westendorf

Manager, Product Development
Phillips-Medisize, a Molex company

Jeremy Odegard

Principal Industrial Designer
Phillips-Medisize, a Molex company

Bridging the Gaps - Innovative leaders can smash stereotypical boundaries by fostering a culture of connection over conflict

  • Discovering mutually-beneficial solutions to complex problems will demand courage, creativity, and commitment
  • Studying a problem from multiple perspectives may reveal a more complete vision of success
  • Expecting cross-functional collaboration will encourage diversity of thought and promote respectful challenge
  • An authentic sense of empathy can highlight shared objectives and transform opponents into partners
View More

available:  Slides |  Video

Quality & Regulatory

Kelly Stanton

Director, Quality
Qualio

THE SHIFT TO DIGITAL: LEVERAGING CLOUD-BASED QUALITY MANAGEMENT SYSTEMS

  • Why uniting your teams, processes, and data is the key to get to market quickly and scale successfully
  • Tips for migrating from a paper-based QMS with case studies
  • Audit best practices and gotchas to avoid mistakes with cloud-based quality software
  • Open Q&A on digital QMS best practices
View More

available:  Video

Innovation

Tony Brennan

Commercial Director, Healthcare
CSA Group

International Approvals for Medical Equipment with Wireless Capabilities

  • Advancements in wireless technologies have led to a new generation of medical devices requiring wireless and other radio approvals and certifications
  • Learn about the leading certification schools for radio approvals and how they relate to product approvals and certifications in other countries
  • Gain an understanding of the certification processes in selected markets
View More

available:  Slides |  Video

1:05 pm – 2:05 pm CST

Lunch & Learn Roundtable Discussions and Open Seating Lunch

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers.
Choose from:

Kelly Stanton

Director, Quality
Qualio

Cloud-Based Quality Management: A Deep Dive Into Actual Implementation, Project and Change Management, and Deliverables

Joseph-Richardson Larbi

Medical Device Regulatory Consultant
Celegence

Process and technology efficiency in post-market surveillance documentation for EU MDR

Jennifer Sippel

VP, Strategic Relationships
oneSOURCE, an RLDatix Company

oneSOURCE Document Site, Safer Together Manufacturer’s Program

Nathaniel Henriod

Product Manager
MasterControl

Where can I invest in technology and innovation to have a significant impact on my business?

Ed Walsh

VP, Global Sales
Sigmetrix

Effective Collaboration Across Multiple Functional Groups Throughout a MedDev Product's Lifecycle - Is It a Reality

Corbett French

Laboratory Director
Nova Biologicals, a Tentamus company

Considerations for selecting a third-party quality lab

John Fox

Manager, Sales and Client Success
ResoluteAI

The Hitchhiker's Guide to the Dataverse: A shortcut to better product design and decision making

John Wells

Account Director, Industrial and Healthcare
Locus Robotics

The Right Robot for the Right Job: Selection Criteria for Autonomous Mobile Robots

Elizabeth McCullough

Senior Director, Linguistic Validation Operations
RWS

Putting the patient first: The Impact of recent FDA recommendations on medical device development

Brett Freeman

President
Providence Enterprise USA, Inc.

Medical Device Manufacturing in the East and West

Sabitha Aboo

Director, Regulatory Services
Indegene

Connecting the dots across Clinical Evaluation, Post Market Surveillance & Risk Management for EU MDR Compliance

Maziar Adl

Co-founder and CTO
Gocious

Setting value-based outcomes from within your product strategy

2:10 pm – 2:45 pm CST

Workshops

Design

Ed Walsh

VP, Global Sales
Sigmetrix

Better Medical Devices through Better Understanding and Management of Mechanical Variation

  • Considering variation in FDA 21 CFR Part 820.30, ISO 16142-1:2016, ISO 13485:2016 throughout the entire product lifecycle vs mostly during verification & validation in the design phase
  • Discussing and addressing variation across multiple functional groups in an organization
  • Making the management of variation insightful and valuable to multiple levels of authority in an organization
  • Trends and how this may influence MedDev success
View More

available:  Slides |  Video

Product Development

Jamie Hijmans, Ph.D.

Program Director, Global Regulatory Technology Operations
GLOBAL CRO

Artificial Intelligence and Machine Learning: Facts, Fiction, and Possibilities for the Future

  • Common myths and misrepresentations surrounding artificial intelligence (AI) and machine learning (ML) technologies
  • Setting realistic expectations for current AI and ML technologies
  • Tips for evaluating AI and ML solutions – how to cut through the hype, marketing, and messaging
  • Less may be more: rethinking how we approach the development and implementation of AI and ML technologies
View More

available:  Slides |  Video

Quality & Regulatory

Priya Bhutani

Founder and CEO
RegDesk, Inc.

Pioneering the Use of AI for Regulatory Information Management Software

  • AI applications for regulatory information management software (RIMS); what they are, what they’ve contributed to regulatory affairs so far, and how they will affect the future of the industry
  • How streamlining regulatory processes with AI RIMS has altered the regulatory affairs landscape for pharma and MedTech
  • Overviewing the role of AI in an increasingly automated industry
View More

available:  Slides |  Video

Innovation

Raghvendra Sahai, Ph.D.

President and CEO
ARL-EuTech, a Tentamus company

Ensuring Chemical and Biological Safety of Medical Devices

  • Material Selection and relevant information
  • Chemical Safety including extractable and leachable
  • Biosafety: Sterility and endotoxin testing
  • Biocompatibility
  • ARL-EuTech can help
View More

available:  Slides |  Video

2:50 pm – 3:25 pm CST

Sessions

Design

Deepak Gaddipati

Founder and CTO
VirtuSense Technologies

Accelerating Access to Healthcare Using Artificial Intelligence

  • How VirtuSense's AI-powered fall prevention solutions cater to each patient's needs
  • Using AI to predict which patients are at an increased risk for health complications or negative outcomes
  • Paying for medical AI: reimbursement and funding opportunities
  • Key considerations: pacing your organization with new device technologies along key workflows and data sources
View More

available:  Slides |  Video

Product Development

Maneesh Shrivastav, Ph.D.

Senior Director, Strategic Innovation, Technical Fellow
Medtronic

Developing a Vision and Strategy for Product Innovation

  • Focusing on the art and science of global medical device market development
  • Formulating and implementing long-term strategies with respect to new and emerging technologies that advance organizational goals
  • Commercialization schemes: How do they differ between startups and well-established organizations?
  • Overseeing multiple international product launches
View More

available:  Slides |  Video

Innovation

Valerie Obenchain

Founder and CEO
Advanced Interactive Response Systems (AIRS)

SMALL MEDTECH, BIG IDEAS: EARLY STAGE INNOVATION PLANS FOR SMALL COMPANIES

  • How can you be proactive and have an entrepreneurial mindset as a team-oriented leader?
  • Sharing leadership characteristics that define business success besides resilience (setting by example, compassionate leadership)
  • Key considerations for protecting your intellectual property
  • Finding your niche in a competitive medical device market
  • Case study: Zeroing in on unmet needs in oxygen therapy
View More

available:  Slides |  Video

3:30 pm – 4:50 pm CST

Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings

Sponsored by

4:55 pm – 5:30 pm CST

Innovation Spotlight

John Mastrototaro, Ph.D.

CEO
Movano

Wearables: Powering the Future of Healthcare Innovation

  • Overviewing the intersection of medical devices and consumer devices
  • Redefining personal health to fit seamlessly into existing daily routines
  • Ensuring design, prototyping and process transparency
  • Leading global product management and design operations
  • Navigating the future of health tech wearable devices (chip innovation, AI, connected devices, and more)
View More

available:  Slides |  Video

5:35 pm – 6:10 pm CST

Closing Keynote

Jijo James, M.D.

Chief Medical Officer, MedTech & External Innovation
Johnson & Johnson

The Importance of Closed-Loop Systems: Leveraging Data and Technology to Elevate Patient Safety

  • Driving MedTech innovation with patient safety at the core
  • Strengthening pre and post-market surveillance and risk management of medical devices
  • Proactively sharing data in collaboration with industry organizations to align with industry best practices
  • Working with regulatory agencies (e.g. FDA) on using RWD/RWE to support clinical trial designs that can inform regulatory decisions
View More

available:  Video

6:10 pm – 6:15 pm CST

Chair's closing remarks

Design

Nina Goodheart

SVP and President, Structural Heart and Aortic
Medtronic

Product Development

Nicole Young

Director, R&D Program Management, Core Diagnostics, IACC
Abbott

Quality & Regulatory

Jody Powell

VP, Regulatory Affairs, Quality Assurance & Clinical
Stryker

Innovation

Alind Sahay

VP, Research & Development
Pentax Medical

6:15 pm – 7:15 pm CST

Networking drinks reception

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