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2nd Annual Strategic Medical Device New Product Development Conference

May 16-17, 2016 | Arlington, VA

DAY ONE | DAY TWO

DAY TWO

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, Director, Product Development, ACELITY

Jack Kent, Director, Regulatory Affairs & Project Manager, Veterinary Devices
CLEAR GUIDE MEDICAL

Glenn Kanner, Vice President, Development & Manufacturing
RINOVUM WOMEN’S HEALTH

 

9:30 COFFEE & NETWORKING BREAK

 

10:00 INCORPORATING HUMAN FACTORS AND USABILITY ENGINEERING TO ENSURE ADHERENCE TO FDA REQUIREMENTS
On April 3, 2016 the FDA will release the ruling for “Applying Human Factors and Usability 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 AND CLEARANCE: STEERING NEW PRODUCT DEVELOPMENT INITIATIVES WITH A REGULATORY MINDSET
Although new product development executives do not complete submissions for product approval, understanding the FDA’s perspective and incorporating a regulatory outlook 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 reimbursement representatives from early product development stages will ensure a collaborative 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 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 development 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

Parimal Shah, Director, of New Product Development Programs
MEDTRONIC

 

2:00 ACCELERATION OF PRODUCT DEVELOPMENT TIMELINES WITHOUT JEOPARDIZING QUALITY
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 accessible 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

Philipp Stolka, Chief Technology Officer, Co-Founder
CLEAR GUIDE MEDICAL

 

2:45 COFFEE AND 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 accessible 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 and 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 industry 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 strategic focus and improved management of a diverse portfolio and R&D projects, in effect, 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 and Resuscitation PMO
PHILIPS HEALTHCARE

 

4:30 CLOSING REMARKS AND CONFERENCE CONCLUSION

 

DAY ONE | DAY TWO

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