Happy New Year!
As the dust settles from the holiday madness and end-of-year celebrations, we thought we’d take a quick look back and reflect upon our 2019 journey.
We’re so fortunate to work with an amazing roster of customers and partners whose relationships are invaluable resources for quality feedback, support and industry needs. Customer and market collaboration are instrumental in helping us drive innovation, and the results are evident.
What are we most proud of in 2019?
Enabling direct submissions to GUDID with Innovit’s new GUDID Connector
We’ve had great success with our GUDID Connector as many customers are transitioning from using the GDSN for UDI submissions (GUDID) to our Innovit solution for direct submission. Here’s our detailed write-up that outlines the specifics.
Partnership with B. Braun
B. Braun selected Innovit as strategic global partner for UDI Regulatory Data Submissions, building on our longstanding partnership as the solution provider for global data synchronisation across all markets. Innovit has been the solution of choice for B. Braun since 2012 for commercial data syndication to hospitals and GPOs via GDSN (Global Data Synchronisation Network) – using the Atrify, GHX and NPC data pools
EUDAMED Testing Success
Earlier in July 2019, the EUDAMED ‘playground’ was released for both GUI-based access and M2M data exchange for Actor and Device/UDI submission modules. Innovit was one of only ten organisations selected and tasked with testing this process and reporting back to the EUDAMED DTX Workgroup.
At the conclusion of the initial testing period, we were the only solution provider able to complete all the test cases for Device Registration. Those test results were published by the EU Commission. Based on these initial findings, MedTech Europe requested Innovit to provide a summary of tests and recommendations to the Commission.
And though the European Commission recently announced that the new EUDAMED will not launch until May 2022, the Medical Device Regulation (MDR) will still go into effect in May 2020 as planned. Given this postponement, medical device manufacturers and suppliers now have the opportunity, and ample time, to properly prepare for implementing M2M data exchange with EUDAMED.
Due to the rapid growth of our European business, we decided to bring additional focus and resources to support our partners and customers by expanding our presence in the Netherlands and Germany. Our goal is to help support the Healthcare industry’s transformation towards a more efficient digital ecosystem and regulatory compliance framework. More importantly, we recognise the need to be close to our valued customers.
Our Plans for 2020
As we kick-off the new year, we are excited about launching new products that have been in development over the past 2-3 years. Scheduled for release in Q2 is our MDM.cloud platform, followed by the much anticipated MDM “Genesis” release, and finally EUDAMED Connector, an end‑to‑end solution for both structured master data submissions (BUDI and DI data); and unstructured regulatory data submissions (FSCA, FSN, MIR, PMCF, PSUR, trend reports, Clinical Investigations). We also have a few surprises in store that we will share early in Q1.
We wish you and your teams a very successful 2020!
The Innovit Team