The Complexity Threat: Why Medical Device Teams Need a New Approach to Product Requirements

Medical Device, Medical Device Design,
  • Thursday, November 05, 2020

Why focus on product requirements?

New technology development in the medical device arena has led to increasingly complex new products. This trend will likely increase due to the increasing market of IoT, SAaMD (SW as a medical device), AI, Health Apps, etc. With increasing complexity comes the advent of errors and device failures. This industry trend is evidenced by an increase in product recalls and security issues. Projections indicate that both the frequency and severity of these problems will continue to rise.

To keep pace and maintain oversight, this has also led to the updates and increases in quality regulations and standards in the EU, USA and throughout the world. At the heart of these are proper design controls which dictate methods and traceability of how the device was developed from user requirements to final verification and validation. Clear and accurate product requirements at all stages of the project are key. It is not enough to manage them. Designers need to rethink how they are written.

Unfortunately, poorly defined requirements are a common problem with complex devices and software. Indeed, software is the number one reason for medical device product recalls and many of these can be traced to issues with the requirements. Ensuring requirements are concise, testable, and clearly understood is both more difficult, and more important than ever. Fortunately, there are established best practices and attributes of properly written requirements.

Join this free webinar to gain insights into these best practices and how, when applied and automated through software such as QVscribe, they can provide consistency, quick iteration, and coaching. When your team masters this process, you’ll see clear direction, reduced rework, and improved communication throughout the lifecycle of your product.



Verna Rodriguez, Founder and Principal, Manty Medtech, Adjunct Lecturer, Bioengineering Department, Santa Clara University

Verna Rodriguez has over 35 years of experience in medical device design, development, quality and manufacturing. In 2018, she founded Manty Medtech, which provides product development and design control consulting services to the medical device industry. In addition, she teaches at Santa Clara University in the Bioengineering and Engineering Management departments. Her areas of expertise include product development, root cause analysis, risk management, design control and process validation for medical devices. She received her Bachelor of Science in Mechanical Engineering and Materials Science from UC Berkeley. Before embarking on consulting and teaching, Rodriguez spent the previous six years as senior R&D director at PneumRx, Inc., a Bay Area start-up where she focused on leading the engineering team to develop a nitinol (nickel-titanium) implant for treating patients with severe emphysema. Prior to that, she led engineering teams at Boston Scientific and Guidant Corp. (now Abbott Vascular) for development of various cardiovascular devices including stents, grafts, balloon and ablation catheters and delivery systems.

Message Presenter

James Carr, Account Executive, QRA Corp

James Carr joined the QRA Corp team in 2018.  He has a diverse background in consultative sales. He oversees QRA’s relationships with top medical device customers including Abbott, Boston Scientific, and Medtronic. He is passionate about helping teams to optimize their product development by automating and mastering their requirements practices.

Message Presenter

Who Should Attend?

  • Development Engineers
  • R&D Management
  • Engineering System Administrators
  • Quality Managers and Engineers
  • Program and Project Managers
  • Systems Engineers
  • Requirement Writers

What You Will Learn

  • The growing threat of costly errors and recalls resulting from increasingly complex medical device innovations.
  • The importance of well-written product requirements both for regulatory compliance and from a project management perspective.
  • What makes an effective requirement statement and what rules to follow to reduce the risk of miscommunication.
  • How QVscribe requirements software has the potential to accelerate the time to market, reduce the cost and number of revisions, improve product quality and acceptance in the field…all while training your team to write exceptionally clear requirements.

Xtalks Partner

QRA Corp

QRA Corp specializes in software for the early detection of errors in model-based systems engineering and the rapid development of product requirements and company standards. QRA Corp’s requirements analysis tool, QVscribe, works with MS Office and popular management tools like DOORS, Polarion, and Jama to improve the clarity and consistency of requirements statements. It provides authors, reviewers, and readers with the most helpful insights to improve their requirements exactly when they need it.

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