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Tecres Success Story

Tecres turns more of its innovative research projects into viable products

Orthopedics specialist builds an ultra-efficient project management organization with requirements management from MatrixALM.

ChallengeTo empower internal project management teams to turn their ideas into viable products, Tecres looked for a way to manage requirements, risks and test cases.
SolutionTecres uses automated workflows in MatrixALM to support its requirements management activities from end to end.

Results

Ultra-responsivesupport from Matrix Requirements during implementation
Enhancescollaboration on testing, review, and approval stages
Acceleratespreparation for MDR approval process
Device type:Single use, Implantable, Surgical and laboratory instruments
Device class:Class I, II and III
Medical specialty:Orthopedic
GeographyItaly
Solution Components:MatrixALM

Promoting innovation

Founded in Italy in 1981, Tecres offers a wide range of solutions for orthopedics, vertebral augmentation and cranioplasty. The company specializes in bone cements and pre-formed spacers, and delivers its products in more than 70 countries around the world.

For Tecres, research and development has helped deliver more than 40 years of success in the orthopedics sector, and the company continues to invest in product innovation. The company identified an opportunity to bring more of these product innovations to market by improving collaboration and promoting standardization.

Erika Andreetto, Project Manager at Tecres, explains: “To help ensure that more of our development projects made it to the market, we decided to form a dedicated project management department to support research and development activities across Tecres.”

Looking for a new approach

The new project management organization initially relied on a custom-developed software tool to support product development.

Marco Milani, Project Manager at Tecres, explains: “Our former tool was not designed to address the most important aspects of medical device development: the management and validation of requirements through effective risk analysis. To meet our research and development needs, we looked for

a solution that was designed from the ground up with these imperatives in mind.”

Selecting an agile solution

After reviewing a number of leading requirements management solutions, Tecres selected MatrixALM—a simple but powerful solution that allows teams to manage specifications, tests, risks and more in an agile way.

“The Matrix Requirements solution stood out from the crowd in a number of key areas,” recalls Milani. “Unlike some of the other platforms we considered, MatrixALM is hosted in a secure data center located in Europe, which helps us to ensure that we meet requirements such as the European Union General Data Protection Regulation [GDPR].”

He continues: “MatrixALM addressed all our core technical requirements, and we were also very impressed with the Matrix Requirements team. From the start, they went out of their way to help us understand how MatrixALM could address our needs—and after one year of working with them, we’re confident that we made the right choice.”

Supporting requirements management from end to end

Working closely with experts from Matrix Requirements, Tecres deployed MatrixALM and configured the solution with traceability matrices to support its requirements management activities from end to end.

Andreetto comments: “We started with two licenses for MatrixALM while we familiarized ourselves with the solution, and we’re now training other team-members to use it. When we first started with MatrixALM, the Matrix Requirements team was a massive help. Whenever we had a question or needed support, they were extremely responsive—typically, we received answers in just 30 minutes!”

Embracing standardized workflows

Today, Tecres creates new projects in MatrixALM for each research and development initiative based on pre-configured templates.

At the beginning of the lifecycle, the project management team uses the Matrix Requirements solution to gather requirements and identify risks, and employs a standardized digital workflow to produce test plans and create design outputs.

“By standardizing our development workflows using MatrixALM, we can promote best practices across the organization and help ensure that more products will make it through validation and onto the market,” explains Andreetto. “We also greatly value how the Matrix Requirements solution enabled us to start small and scale out at our own pace.”

Boosting accuracy and efficiency

Since integrating MatrixALM into its project management workflow, Tecres has dramatically improved its ability to manage complex product development projects across its international business. Today, the company’s researchers and project management experts can see the status of projects in real time, and seamlessly collaborate to rapidly advance through testing, review, and approval stages.

“One of the biggest benefits of MatrixALM is that it forces everyone involved in developing a new product to do things in the proper order and following the correct procedures,” says Andreetto. “If a document or an approval is missing, the Matrix Requirements solution highlights that for us automatically. The solution also preserves a full audit trail, which means we can see everything that has changed between different versions of a requirement or specification at the touch of a button—it’s really fast and easy to use.”

Accelerating product development

Tecres is already experiencing the benefits of the new way of working. Using MatrixALM, the company can generate key documentation for notified bodies in Europe automatically— accelerating the process and reducing the risk of human errors during the all-important product validation stage.

“One of the first projects we managed using MatrixALM cleared the first stage of the Medical Device Regulation [MDR] approval process without a single non-conformity,” states Milani. “With the Matrix Requirements solution, we passed an initial MDR audit in just six months—significantly faster than the same process would have taken us in the past.”

Extending the benefits

Looking ahead, Tecres plans to extend its use of MatrixALM significantly. The company is training new users to review and electronically sign documents within the solution, creating opportunities for self-service. And in the future, the organization plans to extend the solution to its sister companies in Germany, promoting greater harmonization across the wider organization.

Milani concludes: “One of the key benefits of MatrixALM is that we can now manage medical device development projects in a more detailed, controlled and efficient way. Having clarity around requirements brings us a step closer to getting a new product on the shelf, and we’re very optimistic that the Matrix Requirements solution will help us achieve this goal.”

MatrixALM addressed all our core technical requirements, and we were also very impressed with the Matrix Requirements team.”

Erika Andreetto, Project Manager, Tecres