Thursday, October 23, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)
| Session 303 - Design Control SOPs |
Morning Session (9:00 a.m. - 12:00 p.m.) - Standard Operating Procedures
Instructors: David Vogel, PhD, and Robert Barrett, Intertech Engineering Associates, Sam Onukuri, Ethicon Endo-Surgery, Inc. and invited industry speakers
This workshop will focus specifically on SOPs related to the design, development, and validation of medical devices. Topics include:
- How to assess your SOPs
- How to detect a broken quality system
- How to structure SOPs to streamline the design and development process while improving the value of the product
- How to deal with human issues when changing SOPs
Afternoon session (2:00 p.m. - 5:00 p.m.) - Design Transfer
Instructors: David Vogel, PhD, and Robert Barrett, Intertech Engineering Associates, Sam Onukuri, Ethicon Endo-Surgery, Inc and invited industry speakers
Defining the Problem
Production Specifications: How much is too much – how little is too little?
- Borrowing Techniques from Software Design and Validation
- Define these terms, describe how concepts can apply to design transfer
- Planning, Life cycles, Identifying Requirements
- Designing, Implementing, Testing & Validation
- Risk Management, Configuration Management
Developing a Design Transfer Process
- Example of a Design Transfer Process
- How to plan it
- How to document it
- How to know if it is working
- What to do if it isn't
Special Considerations for Outsourced Production
- Why is outsourced production different?
- How to mitigate risks identified with outsourcing
Dealing with Legacy and Acquired Products
- Defining the problem
- How does life cycle apply to these devices?
- Developing Design Transfer Processes for these "not so special" situations
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Standard Operating Procedures
Abstract
Standard Operating Procedures (SOPs) for engineering groups can be understated, overwhelming, or just poorly organized. In each case they can result in non-compliance, confusion, wasted time, and focus on unimportant details.
If you’ve ever heard “I’ll do this but it’s a waste of time”, “Why don’t you just let me do my job”, or “All this documentation at the end of the project is just overhead”, you may want to listen in on this session.
A lot of corporate time and money goes into the development and debate over policies, processes, procedures, and plans, i.e. SOPs. There are different incentives for companies to do this, but too often the SOPs themselves become part of the problem, not the solution.
This workshop will focus specifically on SOPs related to the design, development, and validation of medical devices. Topics will include ways to assess your own SOPs, how to structure your SOPs, how to deal with the human issues when changing SOPs. Examples will be liberally used to show how to detect a broken quality system and how to structure or restructure SOPs to streamline the design and development process, while adding value to the quality of the product.
Although the examples used will be from design and development activities, the fundamentals discussed can be applied to SOPs for any discipline.
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Design Transfer
Abstract
Correctly translating a device design into production specifications is always a challenge. It is even more of a challenge when the device is complex or highly technical. Devices which contain software as a “component” present unique challenges that deserve special consideration. Even more challenging are devices whose manufacture is outsourced to a distant plant speaking a different language.
In this workshop we will discuss some of the above challenges for transferring designs to in-house production and to outsourced production environments. Attributes of effective design transfer processes will be discussed. Emphasis will be on the treatment of design transfer as a process of its own and for identifying the requirements for that process, designing and implementing the process, validating the process and managing risk in the process. The concept of a design transfer lifecycle will be discussed. Design transfer process activities will be identified throughout the product lifecycle beginning in the product development lifecycle phases.
Maintenance (legacy) and late lifecycle phase design transfer activities will be discussed as will the issues that are related to legacy, licensed or acquired devices.
Representative medical device manufacturers will participate in the workshop to discuss their experiences in design transfer.
Outline:
Defining the Problem
- Production Specifications: How much is too much – how little is too little?
Defining the Process
- Define terminology: Planning, Lifecycles, Identifying Requirements, Designing, Implementing, Testing & Validation, Risk Management, and Configuration Management
Developing a Design Transfer Process
- Example of a Design Transfer Process
- How to plan it
- How to document it
- How to know if it is working
- What to do if it isn’t
Special Considerations for Outsourced Production
- Why is outsourced production different
- How to mitigate risks identified with outsourcing
Dealing with Legacy and Acquired Products
- Defining the problem
- How does lifecycle apply to these devices
- Developing Design Transfer Processes for these “not so special” situations
About the Instructors
David Vogel, Ph.D., Founder and President, Intertech Engineering Associates, Inc.
David Vogel, Ph.D. is the founder and president of Intertech Engineering Associates Inc., of Norwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Dr. Vogel and his Intertech engineering team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record. Dr. Vogel received a BS in electrical engineering from M.I.T. He earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.
Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates
Robert E. Barrett is a Lead Systems Engineer with Intertech Engineering Associates, Inc., (www.inea.com) in Northern Illinois , with a 20 year progressive track record of leadership, teamwork and results focus, in the areas of software embedded medical device design, systems engineering, quality management and project management. Robert has also spent 18 years with Baxter Healthcare Inc. gaining management experience in a matrix based organization supporting multiple project and process initiatives. Intertech is an outsource engineering service provider to the medical device industry providing services related to product development and validation, validation of quality and production software, training, and management consulting.
Sam Onukuri, Ethicon Endo-Surgery, Inc
Sam is currently a Principal Engineer with Ethicon Endo-Surgery, Inc. a Johnson & Johnson Company (www.ethiconendo.com) . He has over 17 years of experience in Design, development & Launch of Medical Devices. He is a industry thought leader in the areas of Technology Transfer, Emerging Technology Planning & Development and Design for Six Sigma (DFSS). Sam is a certified Master Black belt (MBB) for Johnson & Johnson family of companies. Ethicon Endo-Surgery, Inc. as a part of Johnson & Johnson is a world leader in design, development, manufacturing & distribution of medical devices for minimally invasive endoscopic surgical procedures.
