Thursday, October 23, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)
| Session 301 - Testing Medical Devices for Increased Reliability throughout the Product Life Cycle |
Chair: Randall Nelson, President, Evergreen Medical Technologies
Regulatory Perspective on the Importance of Medical Device: David Mueller and Dean Bruhn-Ding, CVRx
Setting a foundation for good testing practices: Randy Nelson
Reliability and durability testing: Steven Scott, PhysioTest
Role of Biological Testing in the Medical Device and Diagnostic Industry: Krzysztof Karnicki, Medical Laboratory Surgical Services
Preclinical studies: Roy Martin, Jack Risdahl, The Integra Group
Biocompatibility testing: Don Palme, WuXi AppTec
Open forum discussion on testing: All presenters, plus David Mueller and Dean Bruhn-Ding, CVRx
- Testing trends
- Post-market surveillance impact on testing
- Physiological testing Benchmarks
- Q&A
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Abstract
Testing medical devices is an essential part of the full product development cycle. With some of the recent reliability issues that have occurred, correct and complete testing has become increasingly more important for device companies as they strive to increase the confidence in the safety and reliability of their products throughout the market life of the device. Testing takes many forms and, in the best cases, is a process that occurs throughout the product development cycle. This seminar will focus on the different test modes that are required, the complexities of testing, and the increasing importance of testing to provide highly reliable devices based on well-developed requirements specifications and risk management plans. Each presentation will discuss the why, when, how of the different test modes necessary to provide complete testing for a medical device.
Chair: Randall Nelson, Evergreen Medical Technologies
About the Chair/Speaker
Randall Nelson, President, Evergreen Medical Technologies
Randall Nelson is President of Evergreen Medical Technologies, LLC. Evergreen is a development, manufacturing, and technical support company providing full lifecycle project management for class II and class III cardiac and neuro medical devices. Mr. Nelson has developed Class II and Class III medical devices for over 25 years at both emerging and well-established companies. He has been responsible for the development of pacemakers, defibrillators, EP catheters, and angioplasty/stent delivery catheters. Mr. Nelson has brought new technology and products to market and helped develop companies through growing pains and development changes. As a consultant, he has also worked with medical device companies in the LVAD/artificial heart, neurological, urological, and auditory fields. Mr. Nelson has thirteen patents issued to date for medical devices and has written and lectured about medical device technology and product development. He has a Mechanical Engineering degree from the University of Minnesota and an Economics degree from Willamette University in Salem, Oregon.
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Regulatory Perspective on the Importance of Medical Device
Abstract
The speaker will talk about the US and international philosophy for doing testing supporting the regulatory review and approval of medical devices. This will include design and process verification and validation testing of medical devices.
About the Instructors
David Mueller
To be updated shortly
Dean Bruhn-Ding, CVRx
Dean Bruhn-Ding, Vice President of Regulatory Affairs and Quality Assurance for CVRx, Inc. since 2006. Mr. Bruhn-Ding has over 24-years of experience in the medical device industry. He has held positions at St. Jude Medical, Guidant and Angeion in research, product development, regulatory affairs, quality assurance, and clinical affairs. Prior to his current position at CVRx, Dean was the Vice President of Regulatory Affairs for St. Jude Medical (SJM), Cardiology Division and held other Vice President and Director positions at the SJM Daig Division in Regulatory Affairs, Clinical Affairs, and Quality Assurance. Dean earned his undergraduate BS degree in Medical Technology from North Dakota State University.
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Setting a foundation for good testing practices
Abstract
Preparation for successful testing of a device for regulatory submission requires careful planning at the beginning of the project and frequent testing during the development cycle. Thinking about the testing required to provide a safe and effective medical device as you set requirements, design the components and assemblies, and develop new processes will help set the foundation for an efficient and successful test program.
Instructor
Randall Nelson, President, Evergreen Medical Technologies
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Reliability and durability testing
Abstract
The objective of this presentation is to discuss the development of the test strategy relative to the product development process and the end user. Testing is a crucial step in the product development process for medical devices. The key factors, formed during the earliest stages of the product development process, will also be identified.
About the Instructor
Steven Scott, PhysioTest
Steven Scott serves as technical lead for Evergreen Medical Technologies, LLC. He has over 24 years experience in the medical device industry. He has held various leadership positions in the areas of research and development, and manufacturing engineering for companies who manufacture Class II and III medical devices. Steven has four patents issued to date for medical devices and has over 15 publications. He holds a mechanical engineering degree from Boston University.
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Role of Biological Testing in the Medical Device and Diagnostic Industry
Abstract
The session will cover:
- FDA Hematology testing Guidelines
- Blood Contact devices
- Hematology GLP testing - basic overview
- Appropriate study design - what must be done and which mistakes can be avoided
- Protocols and Studies – Basics:
- Good Study design and planning
- Result interpretation (relevant and non relevant tests)
- Test guidance
- Proper sampling
- Bench testing
- Case Studies
About the Instructor
Krzysztof Karnicki, Medical Laboratory Surgical Services
Doctor Krzysztof Karnicki is the Scientific Director for Medical Laboratory Surgical Services Inc.. He is a Scientific Consultant for numerous Medical and Bio-Medical Companies in the USA and Europe. He has authored numerous publications in Scientific Journals.
Doctor Karnicki graduated from the Polish Medical University, and completed his Fellowship at the Mayo Clinic. During his 10 years at the Mayo Clinic he obtained a PhD degree focusing on “Platelet changes during cardiopulmonary Bypass surgical procedure with extracorporeal circulation” (2000). His area of expertise is Coagulation, Thrombosis, Fibrinolysis, Prothrombotic testing, Hematology, Surgery and Visual Imaging technology. He is an active SQA, ASCLS member, participating in GLP and GCP studies and International Clinical Trials. Doctor Karnicki provides client support with scientific audits, product scientific feasibility assessment, and scientific input for FDA submissions.
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Preclinical studies
Abstract
Dr. Risdahl will discuss the unique physiology and considerations for choosing animal species as a models in preclinical evaluations. Dr. Martin will present considerations for preclinical trial design and management and bringing value into studies through the translational research approach.
About the Instructors
Roy Martin, The Integra Group
Roy is a 20-year veteran of the medical device industry and has contributed towards the testing and approval of many diverse medical devices. He holds a BA from St. Thomas and DVM from the University of Minnesota and also attended in a residency program in anatomic pathology there. He has served in leadership positions in both large corporations and "start-up" companies managing preclinical and clinical research programs. His professional focus is on translational research and development of medical devices.
Jack Risdahl, The Integra Group
Jack Risdahl, DVM, PhD brings over 20 years experience in Laboratory Animal Medicine and Animal Research. Following his Ph.D and postdoctoral training, Dr. Risdahl joined the faculty at the University of Minnesota College of Veterniary Medicine as a professor in Swine Immunology and Infectious disease. Additionally, Dr. Risdahl also held a clinical and administrative position with the Laboratory Animal Medicine program at the University of Minnesota Medical School. He joined Baxter Inc. in 1999 and held the position of Director of Veterinary Services and Preclinical studies in the Nextran Division. Most recently Dr Risdahl joined the faculty at the Mayo Clinic in the Department of Surgery. Dr. Risdahl is widely recognized as an expert in swine in biomedical research and has extensive clinical experience with numerous laboratory animal species. He has created a GMP manufacturing facility from the ground up for xentotransplantion products to meet requirements for FDA xenotransplantation products. He was instrumental in obtaining AAALAC certification for the College of Veterinary Medicine at the University of Minnesota and has overseen numerous device and pharmaceutical protocols as the attending veterinarian. Dr Risdahl has been involved in overseeing program, physical animal census >100,000 of species ranging from cattle to mice.
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Biocompatibility testing
Abstract
To be updated shortly
About the Instructor
Don Palme, WuXi AppTec
To be updated shortly
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Open forum discussion on testing
About the Participants
David Mueller
To be updated shortly
Dean Bruhn-Ding, CVRx
Dean Bruhn-Ding, Vice President of Regulatory Affairs and Quality Assurance for CVRx, Inc. since 2006. Mr. Bruhn-Ding has over 24-years of experience in the medical device industry. He has held positions at St. Jude Medical, Guidant and Angeion in research, product development, regulatory affairs, quality assurance, and clinical affairs. Prior to his current position at CVRx, Dean was the Vice President of Regulatory Affairs for St. Jude Medical (SJM), Cardiology Division and held other Vice President and Director positions at the SJM Daig Division in Regulatory Affairs, Clinical Affairs, and Quality Assurance. Dean earned his undergraduate BS degree in Medical Technology from North Dakota State University.
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