Pre-Conference Workshops: Monday, May 24, 2010

8:00 - 10:30 Workshop A: Why Process Organization is Key to Compliance and Product Quality

Process can “just exist” for regulatory audits or can be structured such that you can achieve enormous day-to-day benefits such as; efficient business operations, high product quality, and successful regulatory compliance. Many companies have put processes in place for the wrong reasons. They continue to struggle with harnessing the power of an effective process organization and structure for their businesses to thrive. Process architecture really matters. Getting that important checkmark for process existence is merely a small part of what is needed. This workshop will open your eyes to a no-nonsense approach to a process architectural structure that has enormous business benefits to any business – particularly a regulated business.

What you will learn:

• Processing rationale that affects process organization
• Realizing company attitudes that affect process organization
• Reviewing a typical process prevalent in many companies
• Learning an effective process architectural approach

How you will benefit:

• Understand how and why companies get into process trouble
• Maintain high product quality and regulatory compliance
• Achieve successful product repeatability
• Build efficient business operations

Your workshop leader:

F. Alan (“Al”) Goodman
“The Process Guy” Independent Software Process Consultant.

11:00 - 1:30 Workshop B: Jump Out of the Waterfall: Applying Lean Development Principles in Medical Device Software Development

(Lunch Included)

How many times have you heard “You can have your software on time, on budget, or high quality – pick any two” and wished you could break out of the tradeoff? The enemy is not poor practices, inadequate talent, or lack of rigor, but linear/sequential thinking. Recent developments in team organization, design philosophy, and development models have permitted far higher productivity, and lower defect rates, than were ever possible with the “waterfall” mindset.

What you will learn:

• Understanding key elements needed for nimble, customer-responsive software development
• Applying tools for tracking iterative software development
• Learning approaches to ensure that rigorous, auditable deliverables are produced

How you will benefit:

• Understand how to learn the real requirements even as development progresses
• Learn how to demonstrate progress to management and earn trust
• See how by not “freezing” inputs at a project’s outset, a more robust product emerges faster
• Understand how iterative software development, done right, is inherently safer

Your Workshop Leaders:

2:00 - 4:30 Workshop C: Efficient Verification and Validation—Gaining Product Reliability and Satisfying Regulations on a Budget

The verification and validation process had intensified as medical devices become more complex and interconnected. In order to ensure a quality device and fully comply with regulations, companies must make smart decisions and work thoroughly and efficiently through the validation effort. This workshop will help development teams validate devices in a wellorganized, precise, and cost-efficient manner.

What you will learn:

• Understanding what is required for design verification and design validation
• Using a risk-based approach to focus your team’s energies where they matter most
• Applying defect and process economics to decrease wasted effort

How you will benefit:

• Make smart decisions about what to automate and what not to automate
• Detect errors accurately and efficiently
• Improve team effort and methodology throughout the validation process

Your workshop leader:

David James
Principal Engineer
Covidien Respiratory & Monitoring Systems.

5:00 - 7:30 Workshop D: Risk Management Using ISO 14971 and IEC 62304

(Dinner Included)

The management of inherent risks associated with device\software hazards is a very hot topic among regulatory bodies both domestically and internationally. So consequently the design and development of medical devices and the software used in that development process have received disproportionate attention and scrutiny from FDA. Historically, the commission of FDA has been to assess the safety and efficacy of devices that are to be marketed in the U.S. Many manufacturers are puzzled as to how to effectively meet this criterion. ISO 14971:2007 is a “consensus standard” recognized by the FDA to “support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.” Therefore, information submitted to conformance with such standards helps to establish a new device is safe and effective. Moreover, if any premarket submission contains a declaration of conformity to the recognized consensus standards, that declaration, according to FDA “should, in many cases, eliminate the need to review the actual test data for those aspects of the device addressed by the standards.” This workshop will help participants leverage the consensus standards of ISO 14971 and IEC 62304 and implement a risk based approach to design and development of software and medical device.

What you will learn:

• Leveraging best practices outlined in ISO 14971 and IEC 62304
• Using a risk based paradigm in design and development
• Performing risk analysis and evaluation
• Choosing an appropriate technique for managing risk

How you will benefit:

• Design a safer more robust product
• Implement a simplified defensible methodology for regulatory compliance

Your workshop leaders:

Thomas Bento and Erik Rodriguez
Certified Compliance Solutions regulatory consultants
for medical device manufacturers.