The full potential of digital health is unlocked when medtech companies move beyond simple apps to sophisticated digital health solutions such as artificial pancreas systems, connected infusion pumps, anticoagulation systems and more.
While adding digital to these types of solutions moves the product into a more regulated category, you can also unlock tremendous opportunity in terms of automating interventions and business insights, improving patient adherence and engagement, unlocking new value-based care services and improving patient outcomes.
It’s critical to contemplate your solution roadmap and what type of regulatory strategy you need to support your current and future regulated digital health products. Most medical device data systems (MDDS) or unregulated platforms can not support digital health solutions with regulated features or functionality.
In order to future-proof your investment in an underlying digital health platform, you need a regulated platform that allows you to offload the additional regulatory burden as you deploy more advanced digital health solutions.
Our medical-grade BrightInsight™ Platform uses software and services to capture, transmit and analyze data from CE-marked and FDA-regulated medical devices, combination products, apps and Software as a Medical Device, in compliance with security, privacy and regulatory requirements.
As a regulated digital health platform built under a stringent Quality Management System, BrightInsight can support regulated, connected medical devices all the way up to Class II and III medical devices, Combination Products and Software as a Medical Device intended uses.
The BrightInsight Platform can accelerate time to market for medtech customers, reduce the cost of implementation and maintenance versus developing a custom solution, and scale across products and global markets.
BrightInsight offers connectivity and management for regulated apps, algorithms, devices or combination products.
BrightInsight can aggregate data from multiple sources and can integrate with EHRs and other IT systems.
Clinical, operations and patient engagement dashboards provide valuable insights in real-time.