Talosix provides solutions to device makers using their Real World Evidence platform to get the data they need to be in compliance with regulators, satisfy payers, and gain access to markets.
EU MDR goes into effect May 26,2020, affecting all medical devices sold in the EU. Part of the regulation requires medical devices to have a proactive post-market surveillance mechanism in place. Talosix’s PMS for EU MDR solution provides ongoing data collection appropriate for the level risk of the device.Learn More
Payors today demand evidence to establish coverage and to maintain coverage for procedures. Talosix has a proven track record of providing RWE to CMS that restored coverage forVertebral Augmentation for VCF procedures after publications of RCTs showed no difference between treatment and sham.Learn More
Provider gatekeepers such as Value Analysis Committees where access to sell depends on high quality evidence. Talosix can provide the RWE that shows clinical differences when using a company’s differentiated devices.
Medical Device companies have a narrow view of how their devices are used in the field and anecdotal feedback from sales is inadequate to make informed decisions on next generation features. Companies are blind to opportunities for improved outcomes and acquisition or partnership opportunities are missed.Learn More
Data has always been an important part of the product lifecycle in the device maker industry and randomized controlled trials (RCTs) have been the gold standard for delivering high quality data. Increasingly, however, the limitations of data from RCTs are being recognized by healthcare decision makers and there is an increased appetite for evidence of device performance in the real world. The reason for this simple:
RCTs establish if a product can work.
Real World Evidence establishes that a product does work.
Compliance - Solutions for post market surveillance
Reimbursement - Support to keep payors paying
Market Access - competitive information to gain market share
Market Insights - Insights to plan future products
Talosix works with the largest medical device makers in the world to help meet their compliance, reimbursement, market access & market insights needs for Real World Evidence.
To learn more about how Talosix can help you unlock the power of technology and artificial intelligence for your patients, please contact us.Contact Sales