Medical Devices and Diagnostics | Modis

Medical Devices and Diagnostics

Wim Willems Posted 10 August 2020

A revolution in science and technology is changing the Life Sciences industry. Start-ups and experienced providers are unleashing the power of smart, connected objects and AI-powered big data to bring a step change to medical diagnosis and treatment. Meanwhile, pharma labs are busy developing a new generation of personalized medicine and other drugs to compete against the rising tide of generics.

At Modis Life Sciences Belgium we have mature E2E services funneled into the Fast Launch to Excellence solution which dovetails perfectly into the current and future market needs in the broader MedTech domain, with a special focus tailored to Medical Devices and Diagnostics start- & scale-ups.

We help our customers going from science to operations by providing profound expertise in every stage of this process and beyond. By applying our methodology, we realized the following results at one of our clients in one year:

Our services can be offered as an E2E packaged solution for the start & scale- up market and/or as expertise in one of the below areas to medium- and large-sized companies

Are you looking for a challenging new opportunity within our Modis Life Sciences community?

At Modis, we prioritize your professional development. By putting your talents and ambitions first, we can offer you projects that inspire, challenge and reward you – all in line with your unique profile. It’s a win-win.

Then check out our careers portal!

Process Excellence

Industry 4.0

Changing customer behavior is forcing manufacturers to become more flexible and react more agile. The industrial scenario is evolving to one where resources (plants, people, information) are increasingly interconnected and interdependent. Therefore, innovative technologies are forming the foundation of Industry 4.0. Some of our successful projects are:
  • Upscaling MES to 4.0 via an Electronic Batch Record
  • Set-up, test and deploy of an interconnected system between the client’s ERP and 30 European verification systems
  • Unlock trapped production capacity by identifying value drivers and applying operational excellence

Capacity upscaling and implementation of manufacturing line improvements are a huge challenge for many companies. Thanks to the Modis Project Management expertise we were able to approach these challenges in a methodical manner. The Sr. Project Manager from Modis helped us greatly to build and evaluate business cases, define requirements, drive the project execution in a diligent and efficient way, in constant agreement with the stakeholders’ expectations. Thanks to this excellent support from Modis, we could efficiently introduce new business capabilities and have made an important leap forward to reach our strategic objectives.

Sarah BaudenelleLife Cycle & Operations Lead at BiocartisTweet this

Digital Identification and Traceability

Traceability in the production process is of utmost importance to uniquely identify each finished good produced, and to trace back all materials used to manufacture it. We can help you in setting up a paper-based or digitized batch record, label design and provide Project Management to guide your serialization, traceability or labeling project to success.

Thanks to the Project Manager from Modis we were able to connect and test successfully with the 30 National Databases in Europe in light of the FMD. This involved stakeholder management across 30 markets and several functional departments (IT, Data Management, Regulatory Affairs, Supply Chain, ...). To implement this innovative process against a strict due date, without direct authority, required a great deal of interpersonal and change management skills through a diversity of cultures and additionally the ability to understand a high conceptual complexity. The Project Manager from Modis was excelling in all of this and I especially appreciated the very crisp and clear communication, both verbally as written

Dirk Van Den WouwerEMEA Serialization and Traceability Leader at Johnson & JohnsonTweet this

Product Life Cycle Management

A Tech Transfer is a complex multi-stakeholder process that requires management by experienced consultants and PMs. Inadequate Project Management (i.e. unrealistic timing, poor communication, lacking risk visibility, no budget control and financial insight, ...) is the recipe for project delay that causes negative financial impact for both sending and receiving parties. Modis can lead you efficiently through this trajectory by providing vigorous Project Management, applying our PMBOK based Fast Track To Value methodology.

Regulatory & Compliance Management

Due to the fast-changing regulations in the Medical Devices & Diagnostics industry it can be a challenge to remain compliant. Modis has a proven track in supporting customers in the roadmap to certification and/or compliancy in:

  • Quality Management (System) & Product certification: QMS, ISO13485 & CE mark
  • MDD & MDR (EU): Complying to Medical Device Regulation requirements
  • Good Laboratory Practices / Good Manufacturing Practices

Content & Data Management

Bringing an idea to market does not only rely on efficient and good-quality production, it also requires streamlined Content & Data Management. Modis can help you manage your regulatory data from the start, provide support in QMS documentation, and assist you in setting up trial and submission data:

  • eTMF (electronic Trial Master File)
  • RIM (Regulatory registration, submission, publishing and archiving)

Digital Solutions

It is no secret that start- & scale-ups have many activities running in parallel, resulting in large amounts of data. Modis can help to structure data, and to handle and maintain it. We can for example build tailor-made data repositories through SharePoint. Modis also has a broad expertise in data analysis and visualization, turning data into information, enabling you to make the right strategic decisions. Our success stories in Data Management, Analytics & Visualization include custom dashboards and cloud reporting solutions such as PowerBI, Tableau and VEEVA.

Modis’ Project Managers and Subject Matter Experts have profound experience in bringing your business from science to operations. In close collaboration with your team, Modis will be your partner to tackle your challenges and lead your projects towards successful implementations.