Conference — Session 401THURSDAY, FEBRUARY 16
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About the Chair
W. Heath Rushing, Principal Consultant, Adsurgo LLC
A former professor from the Air Force Academy, Heath Rushing holds a master's degree in operations research from the Air Force Institute of Technology. After teaching at the Academy, Rushing was a quality engineer and Six Sigma Black Belt in both biopharmaceutical manufacturing and R&D where he designed and delivered training material in Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE) and Measurement Systems Analysis (MSA). He went on to become the JMP Training Manager for SAS Institute. In addition, he has been a symposium speaker at both national and international pharma and medical device conferences. Rushing is an American Society of Quality (ASQ) Certified Quality Engineer. Rushing is a co-founder and principal consultant of Adsurgo LLC, a company specializing in advanced analytics consulting services and training for enhanced business performance.
Systems Engineering and Requirements Management
About the Presentation
As many medical device companies strive to integrate the latest technological advances in hardware and software into their products, they often find that the processes and tools they once employed to develop less complex systems begin to either break down or prove ineffective. What is needed is an engineering discipline that can help to manage this complexity while maintaining compliance with the regulatory requirements of the medical device industry. Systems engineering is such a discipline. Well-established in other industries, such as aerospace and defense, systems engineering is also being adopted by many successful medical device companies to accelerate the development of complex new products.
We will cover:
- What is systems engineering?
- Systems engineering and the FDA
- The role of the systems engineer in new product development
- Systems engineering maturity models and best practices
- Requirements engineering and requirements management - the foundation of
systems engineering - Tools and methods for systems engineering
- Systems engineering and product quality
- Systems verification and validation
- Accelerating new product development with systems engineering
About the Speaker
Todd Hansell, Director, Design Quality Assurance, Covidien - Surgical Solutions Division
Todd Hansell is the director of Systems Design Quality Assurance at Covidien's Surgical Solutions Division, a leading manufacturer of electrosurgical hardware and instruments. Todd leads a team of 30 engineers and technicians whose primary responsibilities include risk analysis, design analysis/robust design, hardware/software testing, reliability modeling/prediction, and test automation development.
Todd has been with Covidien/Valleylab since 2003. Throughout his 22-year career, Todd has been involved with various aspects of software and systems engineering, including design/development, hardware and software quality assurance, project management, and technical leadership in the medical, automotive, and industrial control systems industries. His former employers include DAI Technologies, Motorola, and Woodward Industrial Controls. Todd holds a BS degree in Electrical Engineering from Purdue University where he graduated in 1989.
Todd resides in Longmont, Colorado, with his wife, Janine, and two sons, Aidan and Julian. He enjoys cooking, hiking, camping, canoeing, creative writing, and reciting long segments of Monty Python films and skits much to the dismay of his family and colleagues.
Design Controls with an emphasis on Design Verification and Validation
About the Presentation
Design Controls are not just a good idea, it's the law. Medical device development is governed by the FDA (CFR 820.30) and ISO 13485. These constraints require striking a blanace between a structured framework and a flexible framework.
This talk will cover broad principles of Design Controls with a focus on verification and validation. Case studies will be used to illustrate key points, drawing primarily on mechanical devices, in particular drug delivery devices.
We will cover:
- When do Design Controls start?
- How do you write solid requirements that you can test effectively?
- What's the difference between verification and validation?
- How do you decide what to test?
- How do you determine sample sizes?
- What happens if you fail verification testing?
About the Speaker
David Maltz, Director, Device Technology, Novartis Pharma
David Maltz is currently Director, Device Technology and head of the Device Development group at Novartis Pharmaceuticals Corporation in San Carlos, California, where he is responsible for leading the design and development of several novel pulmonary drug delivery systems. David is passionate about leading high-performance teams to develop sophisticated technologies into human centric products, and has 18 years of hands-on and management experience in the design of medical devices, drug delivery systems and consumer electronics. His deep understanding of the product development process is seasoned with a strategic perspective and a rich appreciation for the needs of the market and the emotional appeal of any product.
David joined Novartis as part of the acquisition of Nektar''s pulmonary business in 2009. Prior to Nektar, David was Director of Engineering at CoolSystems, a medical device firm developing products for the orthopedic surgery and sports injury recovery markets. Previously, he was a Principal at Bridge Design, a product development consultancy in San Francisco serving medical device and consumer electronics markets.
David holds a BSE (1989), MBA (2001), and MSE (2002) degrees from Stanford University and lives in San Francisco, California with his wife and two children.
DfM Enabling Technologies – A secret weapon against growth flat-liners
About the Presentation
In this highly competitive environment for medical device, Customers are expecting very high Value/Cost ratio for all the new products that are launch with equivalent or better quality. It is important to take an pro-active approach to develop DFM enabling technologies that can drive long-term cost while increasing value and quality for the customers. This presentation will review some of models that have been practiced and were successful in medical device environment. Including model on how to leverage Global capabilities to maximize the speed to market and cost efficiency.
We will discuss:
- Medical Device Market & Environment
- What are DfM Enabling Technologies?
- How can DfM Tech Portfolio prevent Growth Flat-lining?
- Business Process to build a “Solid” DfM Tech Portfolio
- DfM enabling Tech Portfolio Management
- Leveraging Global Eco-system
- Partner Engagement Strategy
- Critical Success Factors (CSF)
- Governance & Legal Considerations
About the Speaker
Sam Onukuri, Fellow, Engineering, Johnson & Johnson
Sam Onukuri is a Fellow with J&J Medical Device & Diagnostics Sector. He has worked with medical devices for over 20 years, and brings wealth of experience and knowledge. He is a thought leader in the areas DFM/DFX, Technology Transfers, New technology development and Global Capabilities for Growth. He is also J&J certified Master Black Belt (MBB).
Process Transfer (Small-to-Large Scale)
About the Presentation
The goal of all product development efforts is to get to market and be successful. With market success comes the need to ramp up production and the challenge of scaling from initial pilot builds to full-scale market release. For complex medical devices, the challenge of building products in large volumes can be as significant as designing and building the first verification unit. This presentation will discuss the challenges, opportunities and techniques involved in the successful production scale-up of complex medical devices from small to large volumes and the importance of considering scale-up requirements throughout the product development lifecycle.
- Scale-up Objectives
- Getting a head start - DFM
- Establishing a Scale-up Plan & Expectations
- Supply Chain Preparation & Management
- Regulatory Considerations Manufacturing
- Flow Automation Planning & Design Risk & Contingency Management
- On-going Process Control & Improvement
About the Speaker
Dirk Smith, CTO, Minnetronix, Inc.
Dirk Smith is the CTO and co-founder of Minnetronix, a medical device design and manufacturing company. Dirk has over 24 years experience in medical device development, including 15 years in electronics and systems engineering and more than 12 years in business and technology development and management. He has been involved in the commercialization of numerous medical devices including infusion pumps, blood pumps, blood analyzers, laser and RF ablation systems and wearable monitors. Dirk has seven patents and has authored and contributed to several papers and articles in the areas of medical device development, outsourcing, and biomedical sensors and signal processing. Dirk holds a BSEE degree from the University of Iowa and an MSEE degree from the University of Minnesota.
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• Research & Development
• Product Development
• General & Corporate Mgmt.
• Manufacturing
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