Tag Archive for: collaboration software

requirements managementEditor’s Note: This post about moving beyond legacy systems for requirements management was originally published here on DevOps.com May 12, 2020, and was written by Josh Turpin, Chief Product Officer at Jama Software. We’re always proud to share great thought leadership and this informative post from one of our own is no exception!

Getting Past Legacy Software Pains in Requirements Management

If you feel like you have outgrown your requirements management (RM) software, you are far from alone. From complex systems, such as IBM Doors, to document-based tracking through Microsoft Office, legacy RM tools are having a hard time catching up to the innovation occurring in highly-regulated industries. As we see the line between hardware and software become increasingly blurred, development methodologies are evolving faster than ever before. Sometimes, these changes happen day-to-day or even hour-to-hour, making project traceability feel impossible.

No matter how complex the software or notable the reputation, RM providers don’t always deliver a system that matches the goals of teams that need to quickly adapt, innovate, and grow. This misalignment can create several pain points that interfere with productivity. While some can be attributed to shifts in the marketplace, others are directly rooted in the software tools you are using to meet compliance.

Here are some common snafus and how to work your way out of them.

Multiple Stakeholders, Multiple Problems

From avionics to automotive to Medtech, highly-regulated industries see many different stakeholders and players, and that is a good thing. In order to reach peak public and functional safety, it’s crucial to value the input of multiple roles and skillsets. But, what happens if one or some of these folks don’t know how to use your RM software? At best it’s a shame that they can provide their two cents and at worst this begins a recipe for compliance disaster. To sidestep this conundrum, opt for software that seamlessly flows with multiple roles. More so, make sure whatever software you choose integrates user-friendly traceability. It’s crucial that each and every individual on the project be able to see the progress made from beginning to end.

So, You Missed a Deadline…

It happens to the best of us. You were asked to provide feedback on a requirement and you missed your shot to chime in. Whether a colleague left a comment for you in a Word or Google Doc or shot over an email to glean your opinion, the mode of collaboration you have in place failed you. That’s right, this isn’t all your fault. Review processes are too complex these days and they require collaboration software that sets the intentions of the users clearly. This requires real-time editing and notifications to help keep you and your team on track. To prevent falling into this trap, look for an RM tool that prompts the next steps, and sends timely notifications with clear instructions. Conversations about “who dropped the ball” aren’t productive or fair, the RM software you integrate should fill this gap in human error.

You’ve Been Blocked

You are frantically trying to enter crucial data into the system but you are somehow locked out. You can’t get a hold of the person who manages access and you are beginning to feel frantic. This isn’t just frustrating for you, it also poses some substantial risks to the company. On top of losing a couple of hours trying to break into the system, this clunky process inevitably chips away at the desire to provide feedback with any regularity or confidence. This goes against the entire purpose of collecting data in the first place. To facilitate continuous growth and data collection, your RM tool should be open, accessible, and intuitive. Only then will you encourage the kind of constant input and collaboration from stakeholders that is necessary to keep up with breakneck innovation.

When an Upgrade Spells Doom

Back in the day, we all used to get skittish when an iPhone software upgrade notification popped up on our screen. Will I lose all my photos and contacts? What about all those passwords I saved to log-in to my favorite apps? With the advent of the Cloud, much of this fear has dissipated. When it comes to your RM software, your team shouldn’t be afraid to upgrade the system to fix issues, improve security, and access the latest features.

Yet, these systems are often so customized or patched-together that an upgrade could mean disaster. Because the products you are building change and improve over time, you should have an RM system that can adapt quickly. When it’s time to purchase legacy software, weigh the opportunity costs of investing in something so stale. Ultimately, is the pain of being locked-out or unsupported on various platforms worth the headache?

Pain points aside, we are living in an age that has bred the most disruptive and creative products to date. From ultra-fast and sleek electric cars to life-like prosthetics to self-piloted spaceships, we have some of the best and brightest minds toiling away on how to propel us into the future. At the same time, the regulatory environment has become even more stringent to meet both the demands of the marketplace and public safety. It is going to take synced and streamlined teams to decrease time-to-market and meet the ever-increasing demands of compliance. To pull this off, you need collaboration infrastructure in place that keeps your team organized and catches mistakes often missed by disconnected individuals.

If you’re interested in learning more about requirements management, we’ve compiled some great resources for you here.


Editor’s Note:  In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we’re proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by Jama‘s VP of Customer Success, Clay Moore.

Medical device

How Effective Collaboration Can Expedite Medical Device Design

Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.

Weeks after the COVID-19 lockdown, medical device companies continue to face challenges as they manage remote engineering teams working rapidly to keep up with a changing environment. Now that the initial shock has passed, companies are becoming more well-versed in their new workplaces and identifying how to keep remote engineering teams working successfully.

Teams are under pressure to meet quality and compliance standards while staying on pace to hit delivery dates, and optimizing the efficiency of remote engineering teams as they develop complex devices can be difficult. Normally, products can undergo multi-month-long review cycles, which tie up valuable resources. Technology, when properly leveraged, can reduce that review cycle by as much as 75%—a vast improvement.1

Effectively streamlining collaboration is key to expedite design reviews and medical device product launches. The following is how companies can use collaborative technology to maximize output while meeting critical health standards.

Reduce Dependency on Documents

Medical device companies have been forced to come to terms with their current processes to see if they work for remote engineers. Most know that helpful technology exists, but platforms that promise to streamline lengthy processes can be intimidating. Companies that delayed digital adoption are especially disadvantaged.

The document-based requirements management approach often used by medical device companies limits visibility into the design process across teams. This makes it difficult to scale across multiple product lines and versions, especially with teams working remotely, and it increases expenses.

Collaborative requirements management software can help engineers easily communicate and smoothly define, review and validate information digitally to ensure projects are tracking and a clear path to compliance and launch is visible. Effective software reduces manual processes that limit innovation and add time to development.

Medical device companies should seek collaboration tools that help their engineers clearly communicate the path to launch, tasks and ownership, and current status and action items needed. Remote work on complex processes requires seamless communication and understanding where work is being bottlenecked so teams know how to direct their attention.

Stay On Top of Compliance

In the medical device industry, understanding current product regulations is key to shape the product development process. In recent weeks, the FDA has issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.2,3 Companies who have a centralized approach and real-time access to requirements and design can minimize the added overhead of regulatory requirements, streamline development, and minimize risk.

When companies lack resources to efficiently locate regulatory standards and swiftly communicate them to engineers, they’re wasting time and limiting the ability to mitigate risk. Using traditional collaboration tools or Word documents to manage the product development process isn’t effective, leading to teams spending days or weeks to pull together documentation in preparation for an audit. Ensuring compliance requires context and visibility throughout the design process, and innovative tools that structure collaboration and put compliance and regulation at the forefront can provide both.

Good requirements management software uses a lifecycle approach to make sure compliance is integrated into the design process. Team members are held accountable, and workstreams keep track of when signoffs occurred.

Getting compliance right can be a challenge with engineers working remotely—but it is too important and too costly to get wrong. It can cost $600 million to recall a product.4

Remote Collaboration Sets Medical Device Companies Up for Success

Companies forced to embark on their digital transformation journey during this pandemic can save valuable time and money on product launches by embracing requirements management software to help streamline communication, structure collaboration, and ensure compliance.

This level of collaboration is more prevalent than ever, especially considering the state of work may change as we know it. In fact, a Gartner, Inc. survey revealed that 74% of CFOs and finance leaders will move at least five percent of their previously on-site workforce to permanently remote positions post-pandemic.5 Engineering teams need to make remote collaboration an effective part of their normal operating routines, starting now.

By embracing the right technologies, medical device companies are not only investing in supporting their teams at this crucial time but also they are investing in the success of taking products to market, as the world conducts more and more business online.

  1. Case Study: Healthcare Leader Grifols Uses Jama Connect to Cut Costs and Speed Development”. (June 2019). Jama Software.
  2. FDA Relaxes Rules on Ventilators for COVID-19”. (April 2020). The Regulation Review.
  3. EU MDR: Parliament Overwhelmingly Backs One-Year Delay”. Regulatory Affairs Professionals Society.
  4. The Business Case for Medical Device Quality”. (October 2013). McKinsey & Company.
  5. Gartner CFO Survey Reveals 74% Intend to Shift Some Employees to Remote Work Permanently” Gartner, April 2020

Take a look at some of our other resources around collaboration that we’ve compiled for easy review here: