Distributed Trials and Tribulations

Abstract
Medtech developers are looking to make their product development process as effective as  possible and are facing conflicting requirements when it comes to meeting regulatory requirements and reimbursement opportunities.

For example – generation and collection of clinical evidence needs to come from well-designed controlled clinical studies on one hand and  on the other hand needs to be provide generalizable data from near-real-life usage.

The latest developments in wearables, connected medical devices, mobile medical apps, cloud services and APIs (and any combination thereof) present a challenge and at the same an opportunity to revisit traditional clinical trial design management tools and processes.

This has particular significance for clinical operations people in the field who are accustomed to using pen and paper technology.

In traditional trial design, a nurse or physician performs manual monitoring of patient compliance to the trial protocol.

Patients with connected and distributed medical devices can be anywhere – at home, on the street, jacked into a network in an airport – with a plethora of unexpected events from patient surprises to connectivity issues. – traditional monitoring breaks down.


About this talk
This talk will discuss trends in connected medical devices and the  challenges  in assuring patient compliance to the study protocol. 
 
We  will present a novel  approach for real-time monitoring and response, using models of modern cyber-security monitoring.
 
Who Should Attend
Medical device developers, mobile medical device developers.
 
Why to Attend
In this talk, you will gain the knowledge and tools that will save you 6-12 months in your next medtech trial. You will not have to invent the wheel.
 
About the Speaker
Danny Lieberman - Physicist by training, medical device security expert, serial tech entrepreneur and founder and CEO of flaskdata.io and Clear Clinica.