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Innovative Dental Equipment and Technology Company, Convergent Dental, Selects Jama Connect® For Its Quick Adoption and Live Requirements Traceability

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Convergent Dental

In this blog, we partially recap this customer story, “Convergent Dental Selects Jama Connect,® For Its Live Requirements Traceability” Read the entire story HERE.

In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.

In this customer story, we examine how Jama Connect helps Convergent Dental increase efficiency and manage complex product development subject to regulatory compliance. Read the full customer story to find out how Convergent Dental has shifted from cumbersome document-based processes to a more modern requirements management solution, resulting in:

  • Audit preparation decreased from three weeks to one day
  • Streamlined review cycles
  • Plans for leveraging Jama Connect for test management

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Convergent Dental chooses Jama Connect to manage compliance through in-depth reviews and to save valuable engineering time.

ABOUT | Convergent Dental

  • Headquartered in Needham, MA
  • Expertise: Creating breakthrough laser technology that completely changes how people think of dentistry.
  • Awards: The Company’s flagship product, Solea®, was voted a Gold Winner for innovation at Edison Awards 2016.

Headquartered in Needham, MA, Convergent Dental, Inc., is the creator of Solea, the world’s first computer-aided hard, soft, and osseous tissue dental laser.

With an isotopic CO2 beam of 9.3 µm, Solea cuts significantly finer and faster than any other dental laser, with virtually no noise or need for anesthesia. Their unique system, with patented technologies and controls, nearly eliminates the need for the drill – the thing that many dread about going to the dentist.

CONVERGENT DENTAL CUSTOMER STORY OVERVIEW

CHALLENGES

  • Manual, cumbersome processes were slowing teams down significantly
  • Difficulty compiling necessary documentation for compliance
  • Proving all requirements are tested

EVALUATION CRITERIA

  • Easy-to-use platform with a low barrier to entry
  • Out-of-the-box configurations
  • Automated traceability

THE OUTCOME AND THE FUTURE

  • Audit preparation decreased from three weeks to one day
  • Streamlined review cycles
  • Plans for leveraging Jama Connect for test management

RELATED: Eight Ways Requirements Management Software Will Save You Significant Money

CHALLENGES

Manual, cumbersome processes were slowing teams down significantly

As a small team, the development team’s motto is that no one has the option to be “dead weight.” So, when their engineers were forced to spend hours manually editing requirements and tracking traceability using Word and Excel documents, it wasn’t great for team morale, or for their pace of development.

While using Word and Excel, they found themselves tracking across multiple documents, all with their own trace matrix tables relating to different requirements. The fallout from this process is that even a single word or letter change in a low-level subsystem requirement led to updating the corresponding requirements documents and their trace matrix tables. So, a single letter turns into not one change but potentially six changes across five different documents.

This manual method of digging through Word documents led to cumbersome requirements management and traceability tracking from engineers whose time should be devoted to systems engineering for product development.

We have a small team with a large amount of features and updates to perform on an ongoing basis. We all work really hard here, and there’s no option to be dead weight. Getting rid of that wasted time in Word and Excel, and getting our test engineers back to work, is the ultimate goal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Difficulty compiling necessary documentation for compliance

In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.

They knew their requirements were tested, but in order to show proof, they had to go through hundreds and hundreds of pages. They tediously combed through all their records, which took weeks, significantly impacted productivity, and slowed time to market.

“So instead of just being able to reference the reports and say, ‘Look, they’re here,’ I had to put together the list and then ask a team member to go dig down those. And that took him a couple of days to dig up all that testing. So that was the loss, time from our test engineers.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Preparing for the De Novo Submission was a catalyst for this in-depth review of their requirements. If they continued down the path of Word and Excel, an auditor — if they decided to pull on any small little string — would have resulted in more time trying to track down the requirements. This experience was the deciding factor that led them to understand that the Convergent team needed a better tool.

RELATED: A Guide to Good Systems Engineering Best Practices: The Basics and Beyond

EVALUATION

To solve the above challenges, and in order to save valuable time in the development process, the Convergent team knew they needed to move to a modern and proactive requirements management tool.

Many team members had shared their past experience with Perforce Helix, however, when they began evaluating new solutions, they realized they needed more robust configurations and a more intuitive interface than what those could offer.

“When comparing Jama Connect and Helix, ease of use and the interface played a large role in that decision. While Perforce has many strong applications, this specific area is one where Helix fell short.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

The evaluation process for selecting a modern requirements and test management solution ultimately came down to Intland codebeamer and Jama Connect®.

The following capabilities and features were ultimately why Convergent selected Jama Connect:

Easy-to-use platform with a low barrier to entry

Throughout the evaluation process, it was important to the Convergent team that they found a platform that was easy to use, allowing all team members to easily get started without spending significant time learning a complex platform.

As a small team, Convergent needed a platform that would allow them to move quickly and be agile. They didn’t have time to waste when looking for the requirement management tool that would solve their challenges. After completing trials of both Jama Connect and codebeamer, they knew they needed to make a timely decision. They gathered as a team for an internal review where they asked each other questions such as, “How easy was it to learn?”, “How good and intuitive did it feel to use?”, and “How fast can we be onboarded?”

During their evaluation, Jama Connect’s online training videos demonstrated just how easy the platform was to use. After watching tutorials, critical team members felt they already knew how to use the platform and that Jama Connect would provide a good level of support. After their trial, they discovered that the low barrier to entry and quick adoption helped Jama Connect stand out from other platforms and made their team excited when they received approval to start using Jama Connect.

Out-of-the-box configurations

Implementing a new system is a big deal for any company, and while the team knew onboarding a modern requirements management solution would greatly improve the team’s efficiency, they knew that they were facing a relatively significant change. To save time for their quality team, they prioritized finding a solution with out-of-the-box configurations aimed at the design control process.

While evaluating Jama Connect, they found preconfigured design rules that closely matched what they currently used.

“You can’t beat it. It’s too easy. Using the out-of-box configurations, I can just click and view the trace matrix. That was phenomenal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Automated traceability

When evaluating solutions, Convergent knew that a key component of their search revolved around a platform’s ability to automatically — and proactively rather than reactively — create traceability from design, all the way through to verification and validation.

What they found was that Jama Connect was the only platform that could create Live Traceability™, the ability to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans.

The Convergent team knew that this level of traceability would allow the team to work faster, simplify their process, and improve the quality of their project management.

After importing user needs and requirements, creating relationships, and running tests in Jama Connect, the Convergent team realized that traceability became semiautomatic.

“We don’t have to manually maintain traceability because Jama Connect does it for us. Once requirements are in place, Jama Connect just says ‘if you make a change, then here are all the things it affects.’” – Craig Woodmansee, Electrical Systems Engineer, Convergent

To read the outcome from Convergent Dental’s choice of Jama Connect, read the entire customer story here: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


Decoteau Wilkerson
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