2022 is almost here and the holiday season is in full flight!
As another turbulent year comes to an end, the team at Innovit took a moment to reflect on the past year while also looking ahead with zeal and optimism.
Though agility and adaptability are nothing new to us seasoned veterans in the healthcare industry, the past 20 months has seen unprecedented and tectonic shifts in the global healthcare value chain from supply of medical products to health services delivery.
COVID-19 has created tremendous disruption, uncertainty, economic instability, and political volatility. Locally, nationally, and globally, healthcare is top of mind for everyone. Patients and clinicians demand safety and transparency of accurate information, throughout every interaction. This also applies to medical devices within the healthcare supply chain.
Although the effects of the COVID-19 pandemic were still present throughout the year, the focus of 2021 was on EUDAMED and GUDID compliance for medical products suppliers, and advancements in Master Data Management (MDM) for eHealth delivery and strategic supply management for healthcare providers.
Innovit accomplished many achievements in these areas. Here are just a few that we are most proud of!
Although the EUDAMED system release encountered multiple delays as a consequence of the pandemic and European Commission operational issues, Innovit was able to push forward several EUDAMED initiatives, tools and solutions to help Medical Device manufacturers successfully navigate their journey toward compliance, including the launches of:
- The EUDAMED Leadership Council (ELC) – A representative advisory body that provides informed guidance, advice, and/or recommendations on the European Commission’s EUDAMED data requirements under MDR and IVDR which includes participants from a number of leading medical device manufacturers including Arthrex, B. Braun, Bio-Rad, Medtronic, 3M, Molnlycke, Ascensia Diabetes. The formation of this Leadership Council represents a commitment on the part of Innovit and its ELC members to their share expertise & practical experiences, and to leverage the strengths of each participant towards this common goal.
- ELC LinkedIn Group …was also launched to help socialise the shared knowledge and experience of our EUDAMED Leadership Councilors for the EUDAMED user community at large.
- EUDAMED.cloud – A cloud-based solution, providing free access to Innovit’s EUDAMED M2M testing environment for medical device manufacturers to gain visibility into master data requirements for MDR, train employees to begin gathering and validating product data, establish regulatory data review and approval processes, and much much more.
- The EUDAMED Reference Center – A one-stop knowledge center comprising all the documentation and training videos necessary to successfully prepare for and comply with EUDAMED.
With 2022 upon us, FDA’s postponement of GUDID compliance for Class I medical devices until September 24, 2022 must now be met with urgency.
Thus, Innovit launched our GUDID.cloud system – a cloud-based solution that’s designed for validating regulatory data for the FDA’s GUDID and is loaded with online tutorials and audio-visual training materials to help you get started right away. Be 100% prepared for GUDID data compliance before September 2022, and check it out today. Again, in the spirit of making regulatory data compliance simple, we offer free access to try Innovit’s GUDID.cloud testing environment.
Innovit launched our multi-tenanted version of the Genesis platform, codename ‘MDM.cloud’ in March of 2021 with a pilot group of early adopter customers. On October 15, 2021 this systems for made available to all Australian and New Zealand customers, and we’ve seen a majority of customers using the iICE Validator system migrated over to this new & modern platform.
In November, Innovit’s private cloud version for Genesis MDM went live with several early adopter customers to begin their transition from the iICE MDM platform.
And, that brings us to 2022!
Looking forward to the year ahead, Innovit has planned a bunch of exciting initiatives in the works!
New Product Offerings
In addition to our EUDAMED.cloud and GUDID.cloud solutions, Innovit will be adding GDSN.cloud and PIM.cloud – as well as the expansion of our MDM.cloud solution to customers globally. Our tentative timeline for these exhilarating launch events as follows:
- GSDN.cloud – February 2022
- MDM.cloud (global launch) – Q2 2022
- PIM.cloud – Q3-Q4 2022
- Genesis MDM (private cloud). We expect to have all legacy iICE MDM customers migrated to Genesis by the end of 2022.
Knowledge & Reference Centers
The landscape of regulatory compliance is diverse, growing and ever-changing. It’s a monumental task to keep up – for any Regulatory Affairs, Quality Assurance, Master Data and IT professional.
Over the past year, Innovit has been working hard to collect data, develop content, and set up our website infrastructure to communicate the latest information through specific knowledge-based reference centers for EUDAMED, GUDID, GDSN and a Global UDI reference center for UDI.
The first of these knowledge bases – the EUDAMED Reference Center – was launched on December 17, 2021!
Online User Chat Forums
With the launch of our Genesis platform, we’re very excited to announce a series of user community initiatives that include:
- User Chat Forums. These forums will be lead and owned by our user communities – and moderated by Innovit’s iSupport team – as a way of sharing product knowledge, domain expertise and user experience for the benefit of all Innovit users, customers and partners. We want to foster the sharing of industry knowledge, domain expertise and experience in an accessible and open environment.
- User FAQs. Innovit already provides comprehensive and extensive FAQs across all of our cloud-based systems and website Reference Centers. In 2022, we plan to open up our FAQ for our user community to contribute their list of frequently asked questions and contribute to authoring the answers to these FAQs – again, in the spirit of making knowledge and expertise available easily & openly.
- User Q&A. Add new channels for each of our ‘ iii.cloud ’ systems for our users to interact in real-time with one another to exchange ideas, solve master data problems, and help each other with the power of collective knowledge, experience and wisdom!
Updates and additional information about our new products and knowledge centers will be communicated soon!