Objections to Agile and what you can do about them?

Why Should You Attend:

Agile offers great potential for improving medical device development, but what is Agile really? Why is it so hard to pin down? In medical device companies, it is common for QA and RA (and other areas such as hardware engineering) to object that Agile is not allowed or won’t work.

To answer these objections and unlock the productive power of Agile, we need to understand that the approach is not a single “pure” established method, but the application of several key principles, each aimed at achieving quality. Each company must determine what outputs to require, and how to apply the principles.

This webinar will provide you tools for responding for common objections to Agile, and give real-world examples of what medical device companies are doing about them.

Learning Objectives:

• Overcoming objections to Agile practices
• Being able to discuss the meaning of the Agile Manifesto
• Understanding how Agile is not a method, but a mindset
• Determining your next move to gain the benefits of Agile

Areas Covered in the Webinar:

• Classic objections to Agile, and how to answer them
• Basic principles of Agile, and why practices can and should vary
• Clearing up confusion about what the Agile Manifesto means
• How Agile principles and FDA expectations can work with each other (AAMI TIR 45)
• Examples of device companies currently employing Agile approaches

Who Will Benefit:

Managers looking to establish Agile in their Medical Device company, especially:

• Engineering managers
• Quality Assurance
• Regulatory Affairs
• Risk officers
• Project and Product Managers

Instructors Profile:

Nancy Van Schooenderwoert

Nancy Van Schooenderwoert is among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. She has led Agile change initiatives for s/w and h/w in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods in addition to Scrum.

For three years Nancy led her embedded systems software team to 3x productivity of comparable non-Agile teams, while producing fewer than 2 defects per month on average.

Nancy's experience spans embedded software and hardware development for aerospace, factory automation, medical devices, defense systems, and financial services. Her coaching practice spans delivery teams to middle and upper managers. She is a regular presenter at Agile-related conferences worldwide.

Brian Shoemaker

Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

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