Consiliso
The Blueprint for Integrating Business Processes in Medical Device Companies
by
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Medical devices have been around since the creation of the first surgical tools by the Greeks in the 5th century BCE. Starting in the 1800s, with the advent of modern medical practices, companies started making more diverse medical devices. Products during this time included prosthetics, X-rays, surgical tools and supplies. The modern medical device industry exploded in the 1960s, with help from US space program technology spinoffs. New types of devices included the implantable pacemaker, external defibrillator, the balloon catheter and CT scanner. The companies that developed these products found a huge untapped market in making people’s lives better through technology. Also in 1961, the US Food & Drug Administration (FDA) gained authority to regulate medical device clinical trials and related methodologies. Until the early 1960s, no premarket approval or product review processes existed. Then in 1976, in response to a rash of product field issues, the FDA introduced the medical device Good Manufacturing Practices (GMP) requirements, which gave rise to the concept of regulated product quality for all medical devices. Along with the GMP, the FDA also published the Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), known collectively as GXP. With these new regulations, companies began formal documentation of their business and manufacturing processes and builds.
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About the Book
Consiliso is a concept that will help any medical device company properly design business processes.
Mark Rutkiewicz draws upon his thirty years of experience in the medical device industry to present the framework, which seeks to:
break down preconceived notions on implementing the requirements of applicable laws, regulations, guidance, standards, and internal policies;
provide blueprints for every aspect (what, why, and how) of work at your company;
promote transparent companywide information and the ability to quickly adopt changes;
achieve modular and reusable business processes and master datasets across business functions; and
move management controls to key business process metrics, instead of only financial considerations.
The author synthesizes the best practices from Configuration Management II, Information Mapping, LEAN, Six Sigma, systems engineering, and the Capability Maturity Model for integration into a process-based, flexible architecture.
Discover a new methodology for designing integrated business management processes and systems using a process approach that draws on the best practices of numerous fields with Consiliso.
Visit us at Consiliso.com (snap the QR code) to learn more about Blueprint, read our latest helpful blog posts, see where we are holding events, and to contact us for more information.
About the Author
Mark Rutkiewicz BEE, MALS, PE, CMII, is the vice president of quality at Innovize, a contract manufacturer for the medical device industry. He earned a bachelor of electrical engineering from the University of Minnesota and a master’s of applied liberal studies from Hamline University in St. Paul, Minnesota. He is a Kellogg executive scholar, Configuration Management II certified, and a certified professional engineer. His expertise in the medical device industry includes managing all areas of product development, quality, regulatory, operations, and information management activities for Class I, II, and III implantable and nonimplantable medical devices.