Customer Spotlight

Vave Health Decides to Migrate to Jama Connect® to Accelerate Development and FDA Clearance

By |

In this blog, we partially recap this customer story, “Vave Health Migrates to Jama Connect® to Accelerate Development and FDA Clearance” Read the entire story HERE.

Vave Health is committed to revolutionizing the physician-patient experience through innovative, industry-transforming technologies. Their innovative handheld ultrasound device packs the ability to wirelessly connect with your Android or iOS smartphone or tablet.

After initially selecting Matrix Requirements, Vave Health found themselves constrained by the tool’s limited functionality and were ready for a change. Following a requirements management market analysis, Jama Connect® was selected and onboarded due to its ease of use and industry-leading functionality.

Read this customer story to see how now, with more confidence in their processes, Vave health has achieved the following outcomes:

  • Accelerate the release cadence from what previously took a couple weeks, down to a day or two
  • Decrease generation of trace matrices from 30 days to one per project
  • Scale development process with the ability to run multiple projects in parallel
  • Maintain traceability and instantly identify coverage for verification and validation of requirements to respond to action items sooner in development

VAVE HEALTH CUSTOMER STORY OVERVIEW

CHALLENGES WITH MATRIX

  • Reports, such as a traceability matrix, were taking too long to generate
  • The steep learning curve caused most people to revert to working in Word and Excel
  • Inability to develop parallel projects and reuse data between releases, contributed to duplicated work and slower-than-desired release cadence

SELECTION CRITERIA

  • A solution that would scale with their growth
  • Quick-to-adopt and easy-to-use 
  • Strong market presence
  • Ease of data migration

OUTCOME + FUTURE

  • Accelerate the release cadence from what previously took a couple of weeks, down to a day or two
  • Decrease generation of trace matrices from 30 days to one per project
  • Scale development process with the ability to run multiple projects in parallel
  • Maintain traceability and instantly identify coverage for verification and validation of requirements to respond to action items sooner in development

RELATED: 2023 Predictions for Medical Device Product Development

CHALLENGES

In the early days of Vave Health, the development team originally selected Matrix Requirements due to its low cost. While the tool was sufficient for managing their requirements in the preliminary stages of development, as the company began to scale, it became apparent that they needed a more mature, enterprise-grade solution with more robust capabilities.

The main challenges that Vave Health had which led them to seek out a new solution were:

  • Reports, such as a traceability matrix, were taking too long to generate
  • Steep learning curve caused most people to revert to working in Word and Excel
  • Inability to develop parallel projects and reuse data between releases, contributed to duplicated work and slower-than-desired release cadence

As a small team, they did not have dedicated staff to manage requirements – it was a shared responsibility. With Matrix Requirements, the learning curve was so steep, only a few people were able to use it. Even then, it was used similarly to an Excel spreadsheet.

“Matrix Requirements was difficult to use, and it limited our ability to easily extract reports and quickly show traceability. The whole process just took too long,” said Craig Loomis, Vice President of Product at Vave Health.

“One of the deliverables in getting our product released is generating the trace matrix. With Matrix Requirements, it was very cumbersome,” said Sandhya Mitnala, Head of Quality and Regulatory at Vave Health. “We realized that something that should have taken one or two days, and managed through the project, took us almost a month. It was a very manual process.”

Additionally, as the team grew and the development work went from singular to multiple projects, the team ran into limitations using Matrix Requirements.

“One thing we didn’t initially think about when selecting Matrix Requirements was the ability to have multiple projects in motion at the same time,” said Loomis. “Although it was technically possible, there was no good way to extract the trace matrix and manage revisions across different projects at the same time in parallel.”

RELATED: FDA Updates to the Medical Device Cybersecurity Guidance

SELECTION CONSIDERATIONS

In order to overcome the limitations of their current tool, the team set out to find a solution that could meet their current needs and grow with them as they expanded in the market.

“The startup world is unique in that you’re trying to do so much more with fewer resources. Sometimes you do need to leverage technology to automate things that larger companies would be
able to throw bodies at,” said Loomis.

When it came time to evaluate the available solutions in the marketplace, things moved quickly.

“From my experience working with Jama Software® at other companies, and my coworkers’ similar experiences, we wanted to move to a more automated solution and Jama Software was on everyone’s mind,” said Mitnala. “It was a very easy choice for us. All of the solutions we looked at, outside of Jama Connect®, were ruled out quickly,” shared Loomis.

During the evaluation process, the Vave Health team was able to access a sandbox account created specifically for them, so they could test out the solution to make sure it was the right fit.
Because there were so many things already in motion, the team wanted to ensure that data migration would not be an issue, so they could keep moving quickly.

“Before we even signed a contract, we spent time in Jama Connect and had a lot of confidence in moving forward. We knew that our data would be migrated easily, and we wouldn’t be putting our projects at risk,” said Loomis.

Although Matrix Requirements supported some initial needs, the team knew that in order to derive the value they needed, it was time to up-level their tool for requirements management and systems engineering. The return on investment for Jama Connect, a robust, yet easy-to-use platform (which comprised the feature set and functionality they required) would increase efficiencies, simplify compliance, reduce risk, and ultimately speed time-to-market, paying dividends in the long run.

“As a startup, the one thing you must ensure is that you are able to move fast. You’re learning the market, you’re working against your competitors, and speed to market is critical. Especially where there are things that can be automated – that’s where you want to invest,” said Loomis.

To read the entire outcome from Vave Health’s choice of Jama Connect, read the entire customer story here:
Vave Health Migrates to Jama Connect® to Accelerate Development and FDA Clearance
McKenzie Jonsson
Latest posts by McKenzie Jonsson (see all)