2nd Annual NPD Agenda
1 like288 views
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.
2nd Annual NPD Agenda
- 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: