Medical Device Development | IBM Engineering Solutions
Medical device manufacturers face new pressures from many fronts. Devices are becoming more connected and therefore becoming more consumer facing. As consumers become more digitally savvy, they expect a more continuous and progressive release of capabilities delivered to them over time. However, despite the need to deliver fast, medical systems must still address regulatory compliance and ensure that not only do these products address user’s needs, but that organizations can manufacture and sell them.
Many in the medical device industry are looking to lean-agile product development principles and practices to address these challenges. Organizing around value, aligning on a common cadence, building quality-in, as well as continuous integration and delivery practices provide the ability to learn faster, deliver more frequently, and still address compliance concerns.
Important Standards to ConsiderThere are several important standards for compliance in medical device manufacturing.
Produce high-quality products that meet rigorous standards
Today’s electronics and their software environments are evolving at an increasingly rapid pace. Nowhere is that more evident than with advanced medical devices that touch our lives when we are most vulnerable. IBM ELM makes it easier for companies to meet the rigorous medical device standards by addressing the joint challenge of managing simultaneous system and software development.
Learning PathIn this learning module we'll discuss how lean-agile and scaling principles support medical device development and how to build them using IBM’s Engineering solution.
(Part 1) Medical Device Solution Overview
In this module you will learn about IBM’s medical device development solutions
(Part 2) Manage Change & Collaboration
Learn how to manage change, collaboration and configuration management using IBM Engineering Workflow Management (formerly Rational Team Concert).
(Part 3) Testing Quality Assurance & Traceability
In this module we will discuss Testing Quality Assurance and Traceability using IBM Engineering Test Management (formerly Rational Quality Manager).
(Part 4) Agile Model-Based Development for Medical Devices
Learn how to use Agile Model-Based development techniques for medical device development.
(Part 5) MBSE using Rhapsody and Design Manager
In this module you will learn how you can use Model-Based System Engineering (MBSE) using Rhapsody and Design Manager for Medical Device development.
(Part 6) Automating Requirements
In this module you will learn how to automate requirements and provide traceability using IBM Engineering DOORS (formerly DOORS Next Generation).