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.

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An Introduction to AAMI TIR45 | Use of AGILE Practices in the Development of Medical Device Software

An Introduction to AAMI TIR45

Now a FDA Recognized Consensus Standard, AAMI TIR45, provides recommendations for aligning the concepts of Agile Software Development with regulatory requirements and expectations. In this video, we will describe the fundamental concepts of TIR45 and explain the recommendations that medical device manufacturers should address in their use of Agile methods.

Important Standards to ConsiderThere are several important standards for compliance in medical device manufacturing.

IEC 62304

IEC 62304 specifies lifecycle requirements for medical devices and medical device software.

ISO 14971

ISO 14971 is the risk management standard for medical devices.

ISO 13485

ISO 13485 specifies the quality management requirements for medical devices.

FDA Regulations

Several FDA regulations are also applicable to medical devices, including 21 CFR Part 11.

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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).

Whether you already have an implementation in mind or are just getting started, our technology experts focus on your business goals and desired outcomes first. Not sure where to start? We’ll work with you to design and implement the right solution for your team.

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Whitepaper: Optimizing the Engineering lifecycle requires Digital Transformation

Customer and market demands are driving the need for companies to overhaul their old methods for newer, more agile processes that optimize the entire engineering lifecycle. Learn how to overcome modern engineering challenges by downloading this whitepaper.