Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Brian Shoemaker

Medical device entrepreneurs often struggle with the classic triangle of cost, quality, and time to market,traditional, document-centered approaches are slow, expensive, and frequently error-prone. Some look to Agile development as the way out, but many are still skeptical that Agile teams can develop rapidly and still be compliant. This presentation will:

– Examine what Agile is, and is not
– Review experiences of medical device companies currently using Agile
– Outline how to translate the Agile concepts into practice
– Illustrate how Agile works well for risk management, usability, and design reviews
– Describe various pitfalls related to Agile and how to avoid them

The intent is to show that, if properly understood and applied, an Agile approach can breathe new life into the medical device industry in all three areas: competitiveness, compliance, and quality.

Why should you Attend: Your last three medical device projects took much longer than planned. Some of your new products don’t fit well with customer workflow, in the lab or the radiology suite. You need to keep the development budget down, but you also desperately need to bring out a series of new products to stay competitive. Your developers have told you that something called “Agile” would allow them to be more productive, better fit the products to true customer needs, and ensure high quality. What is this Agile thing? Would it really help you? Will following it pass muster with the FDA, or get you in trouble? This webinar will outline fundamentals of Agile and discuss how an Agile approach, properly followed, can improve development time without sacrificing quality or regulatory compliance.

Areas Covered in the Session:
– Understand what Agile is, and isn’t
– Real companies ARE using Agile – and benefiting
– Translate the Agile foundation into practices
– Iteration works well for risk, usability and design reviews
– Recognize and avoid the pitfalls

Who Will Benefit:
– Project Managers (Especially for Cross-Functional Teams)
– Regulatory Affairs Specialists and Managers
– Quality Assurance Specialists and Managers
– Product Managers
– Business Analysts
– Requirements Analysts
– Development Managers

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.