HealthTech Industry Update | Engineering Excellence in Highly-Regulated Environments

Kurt Neubauer

Kurt Neubauer

In a world where medical devices or in vitro diagnostics (IVDs) and health applications are becoming
increasingly complex, so too are the requirements and procedures for developing these devices.
Today’s engineers often struggle to implement new methods and regulations, while also continuing to work as efficiently as possible when they develop novel technology products.

Each system – or system of systems, in some cases – goes through an engineering lifecycle, which is
sometimes referred to as a product development lifecycle. In terms of today’s DevOps and value
chains, these life cycles can range from a very early ideation phase to end-of-life activities for an
obsolete product.

In some cases, key practices are simply added on to existing legacy workflows, whether it is modern
engineering methods or new regulatory requirements:

➡️Agile and Lean Practices in a Regulated Environment

➡️Lean Portfolio Management

➡️Design for Six Sigma / Reliability Engineering

➡️Product Cybersecurity

➡️Data Privacy Engineering

➡️Artificial Intelligence

➡️Computer Systems Assurance

➡️Legacy Quality Management Systems

➡️Truly Integrated Lifecycle

Simply adding spot improvements often results in an inflexible process landscape without an
integrated, consistent end-to-end approach.

The integration from initial policy development to the tool workflow, covering everything from
portfolio management to post-launch activities is key.

Deloitte has developed a process model for building a truly integrated lifecycle…

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