Tag Archive for: regulated industries

Tag Archive for: regulated industries

Global research and consulting firm Frost & Sullivan recently released a report on the product development landscape and the challenges that those in heavily regulated industries face. And while the findings were not at all surprising, they were illuminating.

The report, titled “Safeguarding Regulated Products Amidst Growing Complexity,” found that those developing products in regulated industries — such as automotive, aerospace, medical devices, industrial technologies, and semiconductors — faced many challenges to efficiency, including stringent regulatory compliance, an influx of competitors, and significant and increasing product complexity.

The Tension Between Compliance and Innovation

The report states that many organizations continue to struggle with the tension between adhering to strict regulatory compliance standards and innovating. And while innovation and compliance aren’t mutually exclusive, without a process to help balance the two, many organizations feel forced to choose.

So, what’s holding these organizations back?

According to the Frost & Sullivan report, it’s the outdated systems and processes organizations have invested in that aren’t equipped to keep up with the speed of innovation.

“These antiquated systems are often static and spreadsheet- or even paper-based,” writes Frost & Sullivan. “And while they may offer a (possibly false) sense of reassurance against the costs and risks associated with a live digital system, they end up creating more costs and causing more harm.”

Learn how Alight Solutions transformed requirements management for its clients by downloading the case study.

The Consequences of Outdated Systems for Those in Regulated Industries

In addition to throttling innovation, the report found that these legacy systems can also lead to increasing compliance costs due to the inability to stay up to speed with changing regulations. The report also details issues with version control, errors, silos, and inhibited collaboration as outcomes of using outdated, document-based requirements management solutions.

The report was clear in its solution to this issue. Teams in highly regulated industries must use a modern, platform-based solution to manage requirements, risk, and testing in product development. And in addition to risk management and accelerating innovation, the report says, the benefits of switching to a modern requirements management solution are plentiful. More efficient and smarter systems allow for cross-organizational collaboration, the ability for key stakeholders to review and weigh in, and end-to-end traceability to easily prove compliance.

Download this recent report by Engineering.com to learn more about the gap between the increasing complexity of products and requirements management.

The report not only strongly suggests that organizations in heavily regulated industries make the switch to a modern requirements management platform, but also names Jama Connect™ as a top solution. And they provide proof.

The report outlines two case studies which highlight the power of upgrading from an outdated, legacy requirements management solution to Jama Connect.

Here’s a recap of one of the case studies.

Semiconductor Company Removes Errors While Speeding Product Development

One of the oldest semiconductor companies in the world found that to remain competitive, it was increasingly building more complex solutions that integrated software and hardware. Products and projects were getting bigger and more complex, as were the teams designing and building them. Along with more complex solutions, the company also needed to be fast to market to remain ahead in an increasingly competitive space. Hence, parallel product development was also critical, though difficult, as the company had various functions spread across global geographies.

The company used Jama Connect to create a system that enabled these teams and disciplines to work concurrently, with living documents that kept the large volumes of data needed for product development constantly up to date and manageable. As noted earlier, eliminating errors is a fundamental driver for both time to market and regulatory compliance, and Jama Connect meets that need as well.

To see the second case study and access the full Frost & Sullivan report, “Safeguarding Regulated Products Amidst Growing Complexity,” download it now.

As in the majority of industries today, the complexity of avionics products is rapidly expanding. In contrast, budgets and development schedules are shrinking as teams work to ensure that product safety remains the first priority.

To help Jama’s avionics customers develop safe, quality products on expedited timelines, we’ve teamed up with the safety-critical experts at AFuzion. The result is our Avionics Services offering, which provides teams with an out-of-the-box configuration of Jama Connect specifically tailored for avionics development along with customized training and documentation templates.

Given the forward-thinking nature of our avionics customers, we knew we needed a trusted partner and thought leader to put together this comprehensive package. With offices in New York and Los Angeles, as well as more around the world, AFuzion offers safety-critical certification and consulting for innovators on the cutting edge of avionics, in addition to training and workshops.

Vance Hilderman, CEO and cofounder of AFuzion, calls his team “senior aviation and safety-critical engineers with an average of 20-plus years of engineering experience – plenty of gray hair and hopefully gray matter.”

We spoke with Hilderman to learn more about how Jama Connect customers can leverage AFuzion’s services to develop stronger avionics products.

Q: Can you talk briefly talk about AFuzion, the industries you serve, and the value you offer your customers?

A: Most of our work is aviation, but we also do automotive, satellites, ground systems, spacecraft, missiles, civil aircraft, and military aircraft. Our engineers have worked with 95 of the world’s 100 largest aviation companies. Though most of our work is engineering development, we also do certification, mentoring, and training. Interestingly, we’ve trained 22,000 engineers in aviation development standards, which is more than all 30 of our competitors combined. We also have a large library of safety-critical whitepapers, all developed by us.

Q: Why is requirements management a central concern for your customers?

A: AFuzion teaches that good requirements and good requirements management are key to avoiding erroneous assumptions and creating project success. Project success is created, planned, executed, and measured. You need great tools for that, and such is our reason for standardizing on Jama Connect.

What are examples of weak, satisfactory, and great avionics requirements? Learn more in our white paper, “Aviation Requirements for Airborne & Ground-Based Software/Hardware.”

Q: What AFuzion solutions or services are currently available with Jama, and what benefits do they deliver for our customers?

A: AFuzion’s safety-critical checklists and templates are hugely popular, especially for aviation. Companies get a working solution out of the box and can avoid rework and delays – it’s a huge jump-start to success, especially when used in conjunction with Jama Connect. And AFuzion can provide standards training while Jama provides the corresponding requirements management training. For the clients, it’s a win-win-win.

Q: What’s the best way to leverage Jama to comply with DO-178, DO-254, and ISO 26262 or IEC-61508?

A: First, get training in requirements management from Jama and the relevant standard from AFuzion. Then initiate Jama deployment and AFuzion’s processes and templates. Consider a gap analysis from AFuzion to show how to best minimize rework and optimize successful project certification and compliance.

Q: What are some of the biggest mistakes or misconceptions you see avionics professionals make when they’re first starting to develop safety-critical products?

A: One: Proceeding without a written plan and alternatives. Two: Outsourcing. Engineering is incredibly complex already and it helps when you are all in the same room, same time zone, and speaking the same language. Outsourcing without a CMMI level 4 compliance playbook increases risk. Now, we don’t mind when companies try that: Over half of our clients come to us after they fail at that. But we’d rather see them reduce costs by succeeding first and avoiding failure.

Q: Are aerospace companies doing their best to keep their products secure? What are the cybersecurity threats facing the aerospace industry?

A: Great question. In fact, the FAA and EASA just escalated cybersecurity to the highest level and mandated that all aviation companies deploy proven solutions based upon DO-326A (ED-202A in Europe) before year-end 2019. AFuzion’s aviation cybersecurity whitepaper is very popular and available for free download at our website.

Companies need training, frameworks, and cybersecurity tools throughout development and product deployment/operations, and AFuzion handles all of this. Our new aviation cybersecurity DO-326A / ED-202A training is proving hugely popular: We just had a sold-out class in Munich during Aerospace Tech Week. Threats are rapidly increasing worldwide, so the solutions need to keep up. AFuzion will help ensure that happens.

Q: What are some success stories you’ve heard from people using AFuzion’s services?

A: In just the past three months, we’ve helped companies certify 20-plus aviation products; taught 1,500 engineers how to succeed with DO-178C, DO-254, and ARP4754A; co-developed 10 aviation airborne- and ground-based systems; and have maintained a 100% client repeat rate, where clients call us back for additional work or say they intend to. That’s honestly the greatest reward. Many people think aerospace is staid and boring. Actually, it’s quite the opposite. Aerospace is real technology, real money, real results.

View our datasheet to learn more about Jama Software’s Avionics Services package. And, to see more information specific to the aerospace and defense industries, we’ve compiled a handy list of valuable resources for you!