Jennifer Moore has more than 15 years of experience in Business Transformation across different industries. Her extensive experience includes helping companies navigate complex regulatory requirements through software solutions. She has been developing and deploying large, multi-faceted enterprise software project, driving revenues as well as market adoption.
World-Class Medical Device Manufacturers Trust Minerva
What do they know that you should?
For too long Medical Device companies have struggled with inefficient data management and documentation processes. Operating in a regulated industry brings added challenges as there are many processes companies need to strictly follow.
As an example, the FDA requires medical device companies to keep extensive project and design documentation in a regulated repository. These documents are part of the Design History File and must record the revisions and approvals per the phase-gate process of a project.
Every medical device company knows this, but what many may not be aware of is that these processes could be executed more efficiently. A few examples are how to automatically capture changes to a product throughout its life cycle, how to manage external collaboration with partners, or how to capture changes made to the DHF and DMR.
Multiple, world-leading medical device companies have chosen Minerva’s specific PLM solution for Medical Device. In this blog, I will show why they have done so and how your company could also benefit from our solution.
Force-fitting procedures to solution capabilities
Minerva has provided solutions to the medical device industry for more than 15 years. We have worked with many different solutions, from Oracle Agile to Aras Innovator and now our own solution, Minerva PLM, powered by Aras.
We have also worked with large global companies, small companies with less than 100 employees, and everything in between. Through the years, we noticed that most solutions on the market were force-fitting procedures and workflows of each unique company into the feature set and capabilities in the solution. The result often left employees with a multitude of workarounds, manual processes that should have been automated, and worse – shadow systems to stand up the gaps. When you break out of the system of record to complete daily work, the possibility for errors, missed documentation, and incomplete audit trails grow exponentially.
We decided to turn things around. Through continuous feedback with leading medical device companies, we identified the challenges, needs, and ways these companies would like to operate. That feedback enabled us to design feature sets and capabilities specifically targeted towards the medical device industry while the inherent flexibility we’re known for remains. More PLM with less work.
With Minerva PLM for the medical device industry, we have helped companies like Carestream Health, Teledyne, Biotronik, Dräger, Ottobock, and Valtronic with their challenges by optimizing their processes and providing industry-tailored system support. Below, you will find three detailed descriptions of how we helped improve the user experience, operations, and business results with our solution.
How Carestream Health manages Projects and DHF using Minerva PLM for Medical Device
Historically a heavy user of Lotus Notes and other systems, Carestream began their journey in 2016 when Minerva PLM for Medical Device was implemented on top of Aras Innovator to improve collaboration and project management across global sites. This improved the management of deliverables for both medical and non-medical device projects as well as made New Product Development more efficient.
After migrating a vast amount of data from the former platform into the Medical Device solution, Carestream Health now has all their DHF information inside Minerva PLM.
Now, the solution supports:
▪ The Design and Development Plan (DDP) contains documents for design inputs and outputs, design review, design verification and validation, design transfer, regulatory and several others.
▪ Project management functionalities like Project Record that allows rapid project definition and the Deliverable Matrix that defines deliverables associated with the project phases and automated creation of submission documentation vs the previous manual process.
▪ Automated document change management and PLM driven change control
▪ FDA Title 21 CFR Part 11 compliant document structures and sign off
Ottobock was seeking a platform to enable a single source of truth for product data, and boost future growth
Ottobock, a global market leader in prosthetics, embarked on an IT digital transformation initiative, with a product lifecycle management (PLM) strategy at the forefront. As part of this effort, Ottobock underwent an assessment that looked at their current business landscape in R&D and identified key areas to strengthen the organization. Ottobock was managing documents and data in several different systems. Most processes were document-based – whether physical paper documents or documents stored in several shared databases. Ottobock was looking for a more sustainable way to move forward by eliminating manual processes, transforming non-digital data, and breaking down both data and organizational silos.
Full lifecycle traceability
Together with the Aras platform, Minerva PLM for medical device provides full lifecycle traceability, strong data integrity, and overall increased operational efficiency. By basing its digital transformation strategy on an open platform, Ottobock can make decisions throughout every aspect of the product lifecycle and improve communication and collaboration across the enterprise – resulting in the development of better products with a shorter time to market.
Design History Files (DHF) and Device Master Records (DMR) are managed with the Minerva PLM medical device templates for both DHF and DMR.
"At Ottobock, we work hard every day to improve the quality of life of our patients and users. To achieve this goal now and in the future, our focus is on innovation and outstanding technology," said Erik Albrecht-Laatsch, Director Engineering at Ottobock. "The combined Minerva/Aras platform provides us with a resilient way forward by migrating our data and processes into one central system, allowing us to accelerate product innovation and growth."
Establishing the digital thread across Engineering, Manufacturing and more at Valtronic
Seeking a solution to optimize the digital thread across the company, earlier this fall Valtronic selected Minerva PLM, powered by Aras to boost future growth.
The Minerva PLM solution will provide an integrated environment where Engineering data (part BoM, MCAD, ECAD) will be integrated with SAP and combined with quality and regulatory information (DHF, DMR, Risk Management, QMS). All rolled together with strong processes and automation to enable optimized design control and configuration management across data in the digital thread.
With Minerva and Minerva PLM, ”…we found a partner who had a deep understanding of the industry challenges. Their solution featured a deeper and wider level of out of the box functionalities for our industry than we had seen with any other vendor.” said Jean-Philippe Ruch, IT Director at Valtronic. “On top of that the Aras Platform underneath also provides the flexibility to support our highly specialized needs in some areas and at the same time being upgradeable”.
Valtronic is dedicated to medical devices, from design and development to manufacturing and full assembly of machines with increasing complexity. This means delivering the highest quality for devices encompassing electronics, mechatronics, fluidics, and software to name only a few fields of expertise. BOMs are also getting larger and more complex thus requiring optimized Product Life Cycle Management. Valtronic is now able to optimize its way of operating and streamline the digital thread all the way from design inputs, to design outputs, verification, and validation.
Want to benchmark your own processes against these world-leading medical device companies?
If you wish to benchmark your own medical device practices and processes against these leading companies to see if you stack up, please contact us. Our dedicated Medical Device team can help you pinpoint areas that are working well and those that would benefit from improvement. There’s no cost for the benchmark.
If you want to know more about how Minerva can help improve the processes in your Medical Device company, please contact me at firstname.lastname@example.org