This document outlines the agenda for a two-day conference on strategic medical device new product development. The conference will feature presentations and panels from industry leaders on topics such as forecasting future trends, case studies on product development approaches, portfolio management strategies, incorporating regulatory considerations into development, and accelerating timelines without compromising quality. Attendees will learn best practices for successfully developing new medical devices.

1. STRATEGIC MEDICAL DEVICE NEW
PRODUCT DEVELOPMENT
Accelerating New Product Development Timelines through Forward-Thinking Portfolio
Management, Enhanced Product Testing, Verification & Validation, and Effective Project
Management while Integrating a Regulatory Mindset to Ensure Rapid Product Approval
MAY 16-17, 2016 | ARLINGTON, VA
2nd Annual
DISTINGUISHED PRESENTERS INCLUDE:
www.q1productions.com
Brian Lawrence
SVP & Chief Technology Officer
HILL-ROM
Carl Casta
Director, of Project Management
ZIMMER BIOMET
Gilbert Hausmann
Director, Global Program
Management Office
VARIAN MEDICAL SYSTEMS
Mark DuVal
President
DUVAL & ASSOCIATES, P.A.
Jack Kent
Director, of Regulatory Affairs and
Project Manager, Veterinary Devices
CLEAR GUIDE MEDICAL
Stephen Flint
Vice President, R&D
MEDELA
Russell Roman, PMP
Director, Emergency Care &
Resuscitation PMO
PHILIPS HEALTHCARE
Parimal Shah
Director, of New Product Development
Programs
MEDTRONIC
Kristin Robbins
Director, R&D Program Management
& Product Labeling
HOLOGIC
Philipp Stolka
Chief Technology Officer and
Co-Founder
CLEAR GUIDE MEDICAL
Peyton Yu
Director, Global RD&E
GLOBAL RESOURCES INTERNATIONAL
Neeta Mhatre
Senior Director, PMO, New Product
Development
INTUITIVE SURGICAL
Joe Budzinski
Director, Global Development Center
JOHNSON & JOHNSON
Glenn Kanner
VP, Development and Manufacturing
RINOVUM WOMEN’S HEALTH
Aaron Barere
Director, Product Development
ACELITY
Kevin Tanis
Director, Product Development
BIOVENTUS
Morgan Amsler
New Product Development Manager
ACCUTOME
CONFERENCE SPONSORS:
SILVER SPONSORS: DOCUMENTATION SPONSOR:EXHIBITOR SPONSORS:
SURFACE FINISHING & PERFORMANCE COATINGS
TECHMETALS
NO SALES PITCHES
Sales presentations from outside
consultants are prohibited
OPEN DIALOGUE & GROUP SHARE
Each formal presentation is followed by
15-20 minutes of open dialogue
DISTINGUISHED PRESENTERS
More than 17 presenters meld
perspectives of industry veterans
17+

2. 7:00 REGISTRATION & MORNING COFFEE
7:50 CHAIRPERSON’S OPENING REMARKS
8:00 PANEL: FORECASTING FUTURE TRENDS OF MEDICAL DEVICE
PRODUCT DEVELOPMENT
The future of the medical device industry continues to evolve as people experience
longer life expectancies, regulatory scrutiny increases, and healthcare reform drives
industry change. Disruptive technologies such as 3D printing, mobile health appli-
cations, cloud-based software, remote healthcare, and wireless enablement shapes
the medical device industry and how organizations respond to these technologies will
directly impact the failure or success of companies. A discussion identifying best prac-
tices and methods to drive innovation and value within organizations will allow new
product development executives to clearly see where the medical device industry is
headed in the next few years.
• Impact of technology companies entering the device space
• Predicting the next generation of medical devices
• Designing medical devices for future patient needs
• Shifting medical devices from diagnosis to prevention
Brian Lawrence, HILL-ROM
Kevin Tanis, BIOVENTUS
Joe Budzinski, JOHNSON & JOHNSON
Parimal Shah, MEDTRONIC
8:45 CASE STUDY: A HOLISTIC APPROACH TO STRATEGIC MEDICAL
DEVICE NEW PRODUCT DEVELOPMENT
Oftentimes, engineers develop a disruptive technology that stimulates enthusiasm
across an organization due to its product characteristics and market potential; how-
ever, an innovative product can still fall flat at the time of product launch if marketing,
training and distribution aspects are not considered throughout development. Product
development engineers must champion a holistic approach to R&D, ensuring that de-
vice companies meet forecasted product revenue and a high return on investment.
Neeta Mhatre, Sr. Dir., PMO, New Product Development
INTUITIVE SURGICAL
9:30 COFFEE & NETWORKING BREAK
10:00 ADVANCING NEW PRODUCT DEVELOPMENT INITIATIVES THROUGH
ANALYSIS OF KEY METRICS
Measuring the performance of a company’s new product development process allows
medical device organizations to successfully compete and remain innovative within the
industry, as a comprehensive outlook based on metrics can pinpoint areas of improve-
ment within the organization. Establishing a clear set of metrics that evaluates efficien-
cies and identifies gaps within the organization helps managers to align investments
with strategic goals. Metrics include project costs, time, estimated revenue, resource
tracking and other factors that impact the streamlined development of a new medical
device; these may not be entirely sufficient to position an organization to guarantee
business continuity. When developing metrics, attention must be paid to unintended
behaviors driven into the organization.
Gilbert Hausmann, Director, Global Program Management Office
VARIAN
10:45 PANEL DISCUSSION: VALUABLE TOOLS TO SUPPORT EXPEDITED
& THOROUGH R&D PROJECT MANAGEMENT
New product development executives manage a complex web of processes and re-
sources in the research and development of innovative medical devices, prompting the
importance of finding and implementing productive tools to streamline project man-
agement. Ideally, device companies would like to implement a project management
platform that can be customized based on an organization’s bandwidth, budget and
communication preferences. From visual tools to support communication across an
organization to cloud-based lifecycle management platforms to effectively spearhead
various projects, this panel discussion will offer attendees an inside look at how prod-
uct development leaders utilize advanced platforms to monitor ongoing R&D initiatives.
MODERATOR:
Peyton Yu Director, GLOBAL RESROURCES INTERNATIONAL
PANELISTS:
Russell Roman, PHILIPS HEALTHCARE
Morgan Amsler, ACCUTOME
Stephen Flint, MEDELA
11:30 EARLY CONCEPT GENERATION & INNOVATION TECHNIQUES TO
DEVELOP BREAKTHROUGH MEDICAL DEVICES
Developing innovative products in the medical device industry is essential to the suc-
cess of an organization, and effective methods of concept generation and ideation are
crucial to developing breakthrough medical devices. Using the future of the medical
device industry as a backdrop for ideation and brainstorming practices, new product
development executives are better equipped to think comprehensively about how to
invest resources in developing the next generation of innovative medical devices. An
examination of a company’s journey in early concept generation for new products will
illustrate one way to cultivate a pioneering product.
• Fostering product innovation within a medical device company
• Utilizing customer feedback for NPD progress
• Concept generating activities to enhance product development
Morgan Amsler, New Product Development Manager
ACCUTOME
12:15 LUNCHEON FOR ALL SPONSORS, SPEAKERS & ATTENDEES
STRATEGIC MEDICAL DEVICE NEW PRODUCT DEVELOPMENT
DAY ONE | MONDAY, MAY 16
1:15 EFFECTIVE METRICS TO DRIVE EARLY-STAGE PORTFOLIO
MANAGEMENT DECISIONS
In medical device new product development, effective portfolio management is key
to the overall success of an organization, responsible for the maximization of finan-
cial return, increasing market share and competitive positioning, as well as achieving
overall focus for the projects a company undertakes. Ensuring devices an organization
develops will remain relevant 3-5 years in the future is at the forefront of new product
development executive’s minds. A presentation on the various metrics to measure po-
tential success through maximizing customer value and driving innovation will aid new
product development executives in the profitable execution of portfolio management.
• Staying ahead of the curve to ensure product relevance
• Performing voice of the customer surveys
• Benefit-to-cost metrics prioritization
• Implementing a holistic approach to portfolio management
Kristin Robbins, Dir., R&D Program Management & Product Labeling
HOLOGIC
2:00 ZIMMER BIOMET CASE STUDY: BUILDING A WINNING PORTFOLIO
STRATEGY & STRUCTURE TO SUPPORT PROJECT EXECUTION
• Project ideation – How ideas are fed into an organization project pipeline & evaluated
• Project review & selection – How to determine strategic fit & align project selection
with business strategies
• Pipeline development & project prioritization – How to effectively build a winning
portfolio strategy & structure to support project execution
• Portfolio tracking & management – Best practices for effective management of
active projects in your portfolio
• Critical success factors for effective pipeline & portfolio management
Carl Casta, Director, of Project Management
ZIMMER BIOMET
2:45 COFFEE & NETWORKING BREAK
3:15 DEVELOPING & COMMUNICATING A VALUE PROPOSITION FOR
MEDICAL DEVICES DURING THE DEVELOPMENT PHASE
As NPD engineers develop medical devices, the ability to understand and communi-
cate the value and features of a device from beginning to end is crucial to the over-
all success of a device. A comprehensive and strategic product definition will pave
the way for medical devices to quickly move through the regulatory approval process,
garner coverage from payers and equip marketing and sales departments with the
information needed to bring in revenue. The effective communication of product value
to all stakeholders within the organization will allow the speedy adoption of innovative
medical devices.
• Defining product characteristics
• Focusing on the value proposition for a device
• Conveying the product definition internally
Stephen Flint, Vice President R&D
MEDELA
4:00 CASE STUDY: OVERCOMING CHALLENGES & REALIZING
OPPORTUNITIES FOR IN-HOUSE VS OUTSOURCED PROTOTYPING
While there are many benefits to the in-house manufacturing of prototypes, including
reduction of cost and faster access to models for end users, there are also risks asso-
ciated with in-house production, such as managing an organization’s capacity and the
need for properly trained machinists and additional staff. On the other hand, outsourc-
ing prototyping can often reduce time to market and allow for greater manufacturing
flexibility and regional knowledge. With no one-size-fits-all approach for prototyping,
weighing the opportunities and challenges in prototyping based on company resources
and medical device characteristics is of great importance for new product develop-
ment teams.
• Ensuring rapid prototyping internally or with an outsourced partner.
• Analysis of budget for prototype manufacturing
• Assessing overall capacity management for prototyping
Glenn Kanner, VP Development & Manufacturing
RINOVUM WOMEN’S HEALTH
4:45 ANALYZING THE POTENTIAL UTILIZATION OF 3D METAL PRINTING IN
THE MEDICAL DEVICE INDUSTRY
As 3D metal printing becomes more widely available and used in industries like aero-
space and automotive, new product development teams are intrigued by how this tech-
nology can offer a new means to create innovative medical devices. Benefits of 3D
metal printing include the ability to more easily manufacture complex shapes, reduced
waste in comparison to other manufacturing methods, as well as the ability to custom-
ize parts and the uniqueness of a design. While the long-term potential for high-volume
device production using metal printing has not yet been realized, the ability to use
3D metal printing for prototyping, sample production runs, and creating replacement
parts allows new product development engineers to explore if 3D metal printing is a
viable option.
• Methods for using 3D metal printing to streamline new product development
• Identifying ideal applications for use of 3D metal printing
- External wearable devices
- Clinical study devices
- Orthopedics
- Dental
• Benefits of printing prototypes vs. end use products
Joe Budzinski, Director, Global Development Center
JOHNSON & JOHNSON
5:30 CLOSING REMARKS & CONCLUSION OF DAY ONE
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

3. STRATEGIC MEDICAL DEVICE NEW PRODUCT DEVELOPMENT
DAY TWO | TUESDAY, MAY 17
7:30 REGISTRATION & MORNING COFFEE
7:50 CHAIRPERSON’S OPENING REMARKS
8:00 MEDICAL DEVICE DESIGN FOR MANUFACTURABILITY IN EARLY
STAGE MEDICAL DEVICES
Peyton Yu
Director, Global RD&E
GLOBAL RESROURCES INTERNATIONAL
8:45 PANEL: DETERMINING SAFETY TESTING OPTIONS BASED ON
MEDICAL DEVICE CHARACTERISTICS
Many medical device companies choose to perform product safety testing in-house as
new product development teams have better oversight of the testing process which
ultimately accelerates the speed to market. Alternatively, outsourcing safety testing
can allow for experimental testing to be performed on devices, reduce internal costs
by eliminating non-critical functions and increases the amount of time new product
development teams spend on strategic objectives. A discussion on best practices for
determining if in-house or outsourced safety testing is more beneficial to organizations,
as well as challenges related to each, will provide attendees with a blueprint to decide
which option is ideal.
Aaron Barere, ACELITY
Jack Kent, CLEAR GUIDE MEDICAL
Glenn Kanner, RINOVUM WOMEN’S HEALTH
9:30 COFFEE & NETWORKING BREAK
10:00 INCORPORATING HUMAN FACTORS & USABILITY ENGINEERING TO
ENSURE ADHERENCE TO FDA REQUIREMENTS
On April 3, 2016 the FDA will release the ruling for “Applying Human Factors and Us-
ability Engineering to Medical Devices” along with a “List of Highest Priority Devices for
Human Factors Review” that will give medical device organizations clearer guidance on
what the FDA expects during the R&D phase and at the time of submission. Updates
expected within FDA’s final guidance include risk analysis expectations and formative
testing requirements. Identifying the FDA’s revised expectations for human factors and
usability engineering will provide R&D engineers with a roadmap for meeting regulatory
compliance in developing medical devices with the patient in mind.
• Evaluating changes to FDA’s expectations for human factors
• Human factors & usability engineering based on risk analysis
• Identifying what medical devices require human factors testing
Kevin Tanis
Director, Product Development
BIOVENTUS
10:45 SATISFYING FDA EXPECTATIONS FOR BIOCOMPATIBILITY TESTING
IN MEDICAL DEVICE NEW PRODUCT DEVELOPMENT
Each year, the FDA continues to place more scrutiny on medical device evaluations,
in an effort to approve products with certainty based on safety and effectiveness
claims. The recent changes to ISO 10993 and the accompanying guidance document
published by the FDA requires medical device organizations to assess the safety and
biocompatibility of devices in final form in order to mitigate all risks associated with
improper testing. A discussion on challenges present with the updated and expansive
testing standards as well as best practices to satisfy the FDA’s requirements will be
evaluated and addressed to provide clarity for new product development executives
conducting biocompatibility testing.
• Developing a compliant test design for biocompatibility
• Identifying key pitfalls in biocompatibility submissions
• Examining potential justifications for exemptions of testing
• Addressing test failures to meet FDA requirements
Aaron Barere
Director, Product Development
ACELITY
11:30 ENSURING PRODUCT APPROVAL & CLEARANCE: STEERING NEW
PRODUCT DEVELOPMENT INITIATIVES WITH A REGULATORY MINDSET
Although new product development executives do not complete submissions for prod-
uct approval, understanding the FDA’s perspective and incorporating a regulatory out-
look throughout R&D projects can augment the probability of a speedy medical device
clearance process. Vital to market entry is the ability for product development teams to
work in concert with regulatory counterparts, rather than existing in a vacuum where
product approval is an afterthought. Additionally, as R&D engineers serve as experts
on a medical device’s clinical outputs and product features, implementing an ongoing
committee that includes product design, marketing, clinical, regulatory and reimburse-
ment representatives from early product development stages will ensure a collabora-
tive approach to medical device approval.
• Gearing research & development toward the regulatory submission process
• Working hand-in-hand with regulatory to clearly define product characteristics
• Ensuring product clearance through the 510(k) path, avoiding de novo & PMA
Mark DuVal
President
DUVAL & ASSOCIATES, P.A.
12:15 LUNCHEON FOR ALL SPONSORS, SPEAKERS & ATTENDEES
1:15 UNLOCKING MEDICAL DEVICE TECHNOLOGY OPPORTUNITIES IN
VALUE-BASED HEALTHCARE
As hospitals transition to a value-based healthcare system medical device companies
must also adapt to the changing healthcare environment in order to remain profitable
while advancing partnerships with healthcare institutions. New product development
executives are at the forefront of medical device innovation, prompting the importance
of considering how to address shifting reimbursement models and the definition of val-
ue in health. Incorporating an understanding of the impact of value-based healthcare
on stakeholder expectations for outcomes and cost requires the implementation of a
novel approach to R&D initiatives.
• New opportunities through healthcare reform & data
• Varying stakeholder interpretations of value
• Looking beyond 2016 at the future technology ecosystem
Parimal Shah, Director, of New Product Development Programs
MEDTRONIC
2:00 ACCELERATION OF PRODUCT DEVELOPMENT TIMELINES WITHOUT
JEOPARDIZING QUALITY
As product development executives work to quickly release new medical devices into
the market, mitigating potential areas of concern and pitfalls is crucial to a product’s
development and launch success. Factors pivotal to the successful acceleration of
project timelines include effective internal communication, undoubtedly knowing the
features of a product, and keeping an eye on quality throughout the research and de-
velopment of a new medical device. This session will highlight a case study example
in which timelines for a device were accelerated while mitigating risks associated with
streamlining new product development.
• Various techniques for project management acceleration
• Hitting early deadlines to ensure a smooth development cycle
• Enforcing periodic or weekly reviews to mitigate risks
• Analyzing key metrics in forecasting product development timelines
• Anticipating all risks associated with acceleration
Philipp Stolka, Chief Technology Officer, Co-Founder
CLEAR GUIDE MEDICAL
2:45 COFFEE & NETWORKING BREAK
3:00 EXPEDITING TIME TO MARKET THROUGH STREAMLINED PIPELINE
PLANNING & EFFICIENT RESOURCE CONSIDERATIONS
Sustainable pipeline planning is crucial to the ultimate success of a medical device
organization, as deciding which products to devote resources to can be a complex and
multi-faceted process. Factors to consider in effective pipeline planning include acces-
sible resources, internal company expertise, market forecasting metrics, partnership
strategies and available project management tools. Through the implementation of
a streamlined approach to pipeline planning, new product development teams can
expedite time to market for innovative medical technologies.
• Identifying valuable pipeline planning tools & platforms
• Ascertaining key metrics to determine pipeline success
• Evaluating organizational capacity to advance R&D projects
3:45 SUPPORTING A PROGRAM MANAGEMENT OFFICE FOR
OPERATIONAL SUCCESS
There is variation in how program management offices within the medical device in-
dustry are implemented, as job functions and team make-up are dependent on an
organization’s resources and portfolio objectives. Identifying which fundamental roles
an organization’s PMO requires and the type of project support provided to the new
product development sector, are key to the development and success of the program
management office. The implementation of a PMO provides an organization with stra-
tegic focus and improved management of a diverse portfolio and R&D projects, in ef-
fect, driving the profitability of the organization as a whole.
• Identifying PMO functions & responsibilities
• Preparing PMO implementation plans
• Operating as a strategic partner to NPD teams
Russell Roman, PMP Director, Emergency Care & Resuscitation PMO
PHILIPS HEALTHCARE
4:30 CLOSING REMARKS & CONFERENCE CONCLUSION
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

4. STRATEGIC MEDICAL DEVICE NEW PRODUCT DEVELOPMENT
MAY 16-17, 2016 | ARLINGTON, VA
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Director, Regulatory Affairs, ABBOTT DIAGNOSTICS
Director, R&D, ABBOTT LABORATORIES
Sr Dir., R&D Process Design, ABBOTT LABORATORIES
Director, Program R&D, ABBOTT LABORATORIES
Senior Dir., Regulatory Affairs, ABBOTT LABORATORIES
Director, System R&D, ABBOTT MOLECULAR
Systems Engineering Manager, ABBOTT MOLECULAR
New Product Development Manager, ACCUTOME
Dir., R&D, Product Dev., AMERICAN MEDICAL SYSTEMS
Manager, P&PD Program Management, BATELLE
Project/Program Manager, BATELLE
Director, R&D Surgical Equipment, BAUSCH & LOMB
Director, Research & NPD, BIO-DEVICES
Project Manager, BIOMET
Director, Cellular Therapies, BIOMET BIOLOGICS
Senior Design Engineer, BRISTOL-MYERS SQUIBB
Director, Advanced Development, CARL ZEISS MEDITEC
Global Product Manager, COOK MEDICAL
Product Development Engineer, Surgery, COOK MEDICAL
Development Engineering Manager, COVIDIEN
Program Management Office Director, COVIDIEN
SVP, New Product Development, CYNOSURE
Senior Vice President, Engineering, CYNOSURE
Mgr., Advanced Tech. R&D, EDWARDS LIFESCIENCES
Director, Research & Program Management, HOLOGIC
Senior Director, PMO, NPD, INTUITIVE SURGICAL
R&D Manager, KIMBERLY CLARK
EVP, Research & Development, MAQUET
Director, Engineering & Product Development, MAQUET
Director, New Product Development, MEDLINE RENEWAL
Product Mgr., Global Upstream Marketing, MEDTRONIC
Business Development, MEDTRONIC
Director, Product Development, MEDTRONIC
Dir, Advanced Product Development, MRI INTERVENTIONS
Chief Scientific Officer, NEW WORLD MEDICAL
Director, Project Management, NONIN MEDICAL
Director, Research & NPD, ONCIOMED
Director, NPD, PREMIER DENTAL PRODUCTS
Senior Manager, Product Development, RTI SURGICAL
Project Portfolio Manager, RTI SURGICAL
VP, Corporate Strategic Development, TELEFLEX
Director, R&D, New Product Development, TELEFLEX
Director, R&D Vascular Product Development, TELEFLEX
Manager, NPD, THERMO FISHER SCIENTIFIC
Manager, Engineering, THERMO FISHER SCIENTIFIC
Vice President, Engineering, TRIDIEN MEDICAL
Senior Engineer, TYPENEX MEDICAL
Senior NPD Portfolio Manager, US ENDOSCOPY
Engineering Manager, US ENDOSCOPY
Technical Product Development Manager, WELCH ALLYN
Associate Director, Project Management, ZIMMERBIOMET
PREVIOUS ATTENDEES:KEY CONFERENCE SPEAKERS:
Neeta Mhatre
Senior Director, PMO, New Product
Development
INTUITIVE SURGICAL
Gilbert Hausmann
Director, Global Program
Management Office
VARIAN MEDICAL SYSTEMS
Neeta is an accomplished industry leader with over
twenty years of global experience in diverse organi-
zations from startups to large corporations. Neeta
Mhatre joined Intuitive Surgical as Senior Director of
Project Management Office within the New Product
Development team in Feb 2015. Neeta was with
Siemens for 12 years & had various leadership
roles. She has been on a delegation to India as the
Business Head for the South Asia Cluster. She served as the Chief Information
Officer & VP of Information, Communications & Process within the Siemens Ul-
trasound Leadership Team. Before joining Intuitive Surgical, she was the Senior
Director of Product Management for Product, Portfolio & Strategy team at Sie-
mens. Neeta has worked in product management, marketing and IT across medi-
cal devices, in vitro diagnostics, bioinformatics & hi-tech industry. She has worked
with Genzyme Diagnostics, Hewlett Packard, Yodlee and geneticXchange. Neeta
has an MBA (Marketing & IT) from Santa Clara University and a BS in Biomedical
Engineering from the University of Bombay.
Gilbert Hausmann is the Director of the Global Pro-
gram Management Office in Varian Medical Sys-
tem’s Oncology Systems business. In this function,
he has created and matured a global organization
that houses Business Program Managers and has
full ownership of the project management process
in the business unit. With an emphasis on leader-
ship development, he has grown the organization
from an executional entity to a business partner and nucleus of change for the
broader organization. He has introduced new concepts to drive organizational
change through targeted performance indicators.Prior to his career at Varian, he
held positions in various management roles in the medical device and technology
industries. He is a graduate of the Chemnitz University of Technology in Chemnitz,
Germany.
Executives that will find this program of greatest relevance are those currently
working to develop innovative products within medical device companies. Job ti-
tles of those executives that will find this program to be most applicable to their
job functions include:
• New Product Development
• Product Development
• R&D
• Chief Technology Officers
• Project Management
• R&D Process Design
• Systems Engineering
• R&D Program Management
• Advanced Development
WHO SHOULD ATTEND: