Delivering truly innovative products quickly and inexpensively—without compromising on quality—is difficult. Developing new products that meet these criteria for highly regulated industries like healthcare, automotive and aerospace is an order of magnitude more challenging.
Products in these markets must pass a variety of audits and compliance tests to ensure they can be operated without compromising the safety of the operator and others who might be negatively affected by the product’s failure.
The more global your product’s reach, the more national, regional and local standards you must exceed, often spawning new regional product variants and development tracks in response. As product complexity has increased, so too have the depth and complexity of the certifications themselves, in an effort to keep pace with rapidly changing features and functions.
Addressing these collective compliance and audit requirements takes a toll on the manufacturers trying to bring products to market, often by stifling innovation and slowing the time to market and development cost targets manufacturers need to ensure profitable growth.
Step One: Embracing Application Lifecycle Management
The complexity of products has exploded over the last decade or more as they’ve become increasingly reliant on software to operate properly. In 2010, the average passenger vehicle rolled off the assembly line with 10 million lines of software code onboard. By 2016, that number had grown to an average of 150 million lines for the most popular pickup truck in the U.S.
As hardware-based products have become more software-centric, product developers are adopting Application Lifecycle Management (ALM) solutions created to aid the development of software applications.
These ALM platforms are far superior to the highly manual and disconnected legacy approaches that preceded them. Not only can they increase process efficiency and individual productivity by seamlessly supporting the specific needs of each phase of the software development process, but their ability to unlock the potential for end-to-end traceability is essential in highly regulated industries.
For example, IBM’s Enterprise Lifecycle Management (ELM) is one of the most trusted ALM solutions available, due in part to its ability to automate the creation and maintenance of relationships throughout the development lifecycle, including relationships between requirements, work items, architecture, design, and test plans.
When compliance audits take place, ELM users can deliver specific reports detailing every aspect of the software’s development, including what users were involved, what exactly was changed, and when. Critically, these results are delivered instantly with 100% completion and accuracy, since each action had been logged by ELM automatically, across all phases of development.
Step Two: Accelerating Compliance with Industry-specific Templates
For product developers targeting the automotive industry, ELM offers specific support to accelerate compliance with the Automotive Process Improvement and Capability Assessment Model (ASPICE) standard, including:
- Templates: repeatable, compliant patterns that simplify the ASPICE compliance process
- Asset libraries: ELM comes pre-populated with ASPICE-compliant sample data, offering real-world examples to reference.
- Project dashboards: ELM’s built-in data visualizations include ASPICE-specific modules with essential KPIs and metrics, ready to be customized for your specific needs.
- Agile process guidance: including process definitions, guidelines and descriptions for systems engineering that support both Agile and ASPICE.
- Detailed reports: dedicated reporting to deliver insight into ASPICE compliance status for assessments.
For products intended for the aerospace and healthcare markets, ELM works in concert with and supports a variety of leading manufacturing processes, standards, methods and models, including:
- Aerospace & defense: ARP4754 and DO178C
- Healthcare & medical: Federal Drug Administration (FDA), 21CFR part 11, IQ, OQ, PQ, PV, GAMP, EU GMP Annex 11, HL7, HIPAA, LOINC, ANSI X12, ICD-9/10, and DICOM
IBM ELM accelerates the adoption and implementation of industry-specific regulations and standards by making it a natural by-product of work outcomes, rather than a dedicated task.
Step Three: Incorporate ALM-adjacent tools
As product complexity has increased, developers and engineers have adopted a variety of additional development tools to help them meet rising innovation speed, quality and cost targets. Project management and issue tracking tools like Atlassian’s Jira® have quickly become essential elements of the development ecosystem, along with open source initiatives like Git for code management.
When these tools function independently from the ALM platform, they blunt the effectiveness of each tool and the processes they support, due to the lack of free-flowing data which limits productivity and end-to-end visibility. More importantly, for highly regulated industries, this disconnect may limit the traceability of critical information needed for compliance audits, which can force the need for costly and time-consuming manual tracing.
To allow product developers to maximize the value of tools like Jira and Git without compromising their productivity or the traceability of their product development effort, the industrial integration experts at Persistent Systems have developed the Persistent UNITE integration foundation.
Persistent UNITE is a family of lightweight integration plugins that tightly integrates IBM’s ELM tool set with Atlassian Jira, Git—including GitLab, GitHub and BitBucket—and soon, ENOVIA®, the product lifecycle management (PLM) platform from Dassault Systèmes®, the world leader in 3D design and engineering software.
UNITE leverages Open Services for Lifecycle Collaboration (OSLC) to create relationships between artifacts, enabling integrations with IBM ELM tools without the need for data synchronization.
The tight integration delivers a “single version of the truth” anywhere in the organization, and when compliance audits are conducted, ELM’s reporting is able to automatically incorporate Jira’s issue tracking and project management data, Git’s source code repositories, and CAD-native files and more from ENOVIA’s hardware development processes.
Fully integrated products demand integrated product development ecosystems
As hardware-focused products have become more software dependent, the complexity of the products themselves has exploded, along with the regulatory requirements in safety-critical industries like healthcare, automotive and aerospace.
Successfully developing and delivering innovative, robust products for these regulated markets quickly and cost-effectively demands a new class of innovative, robust development solutions. Solutions that seamlessly link the end-to-end processes and data needed for hardware development and software development alike, allowing developers to quickly access the tools and information they need – anywhere and anytime – and that ensure industry-specific compliance every step of the way, automatically.
Let the industrial integration experts at Persistent Systems help you bring this integrated ecosystem to life in your organization, unlocking breakthrough performance for your employees, processes and products. Visit to find out more.
ABOUT THE AUTHOR
Bertrand Raillard
Offering Manager, Persistent Integration Platform
Persistent Systems, Ltd.
Bertrand Raillard is responsible for leading the Integration products and services offerings at Persistent Systems, enabling customers to create truly end-to-end digital solutions using their preferred engineering platform.
To accomplish this, Bertrand relies on 25 years of experience in the software industry, with the last two decades focused on supporting a variety of industries and manufacturers of everything from blast furnaces and grain silos to jet fighters and chewing gum.
Bertrand holds a bachelor’s degree from ISTEC, the Institute of Higher Education in Marketing and Commerce in Paris, France.
