How to improve patient compliance in your medical device study
Here’s an idea that will make you slap your forehead. You can just stop transcribing case reports on paper. FDA eSource guidance recommends direct data entry into your EDC. The eCRF becomes electronic source and you eliminate source document verification. You save money, systems, time and you get to go home early. Don’t let people confuse […]
Treating EDC Induced Dissociative Panic Disorder
There is considerable online discussion about real-world data in clinical trials, virtual trials, digital trials, medical IoT, wearables, AI, machine learning for finding best candidates for treatment and digital therapeutics. From the EDC vendors’ web sites – everything is perfect in a perfect world. Medidata Rave – for example: Run Your Entire Study On A Unified, […]
Killed by code in your connected medical device
Are we more concerned with politicians with pacemakers or families with large numbers of connected medical devices? Back in 2011, I thought it would only be a question of time before we have a drive by execution of a politician with an ICD (implanted cardiac device). May 2019, with mushrooming growth in connected medical devices (and […]
4 strategies to get connected medical devices faster to FDA submission
Introduction Better designs, site-less trials, all-digital data collection and PCM (patient compliance monitoring) can all save time and money in connected medical device clinical trials. This article will help you choose which strategies will be a good fit to help you validate your connected medical device and its intended use for submission to FDA. What […]
Putting lipstick on the pig of electronic CRF?
Good online systems do not use paper paradigms. In this post – I will try and entertain you with historical perspective and quantitative tools for choosing an EDC system for your medical device study. Decades of common wisdom in clinical trials still hold to a paper-based data processing model. One of the popular EDC systems […]
Israel Biomed 2019-the high-social, low stress STEM conference
Impressions from Biomed 2019 in Tel Aviv This week was the annual 3 day Biomed/MIXiii (I have no idea what MIXiii means btw) conference in Tel Aviv. The organizers also billed it as the “18th National Life Science and Technology Week” (which I also do not know what that means). This was a particular difficult […]
Living off generic solutions developed in the past
I recently read some posts on Fred Wilson’s blog and it was impressive that he writes every day. I’ve fallen into the trap of collecting raw material and then waiting to find time to write a 2000-word essay on some topic of importance to me. But, I think it was Steve Jobs who said the […]
Perverse incentives
The perverse incentive for the high costs of medical devices and delay to market The CRO outsourcing model and high US hospital prices result in higher total CRO profits via higher costs to companies developing innovative medical devices. These costs are passed down to consumers after FDA clearance. We’ll take a look at the cost […]
Teetering on the precipice of medical device/digital health clinical trials
Danny teeters on the edge of the precipice of privacy and security. Step on the brakes not on the gas and don’t look down. Take a 500m leap of faith into the chasm of medical device clinical trials. Validate digital therapeutics. Venture into uncharted territory of medical cannabis trials. At some stage in my “let’s […]
When is patient compliance important in medical device clinical trials?
In this post, Danny Lieberman, founder of flaskdata.io , discusses when patient compliance is crucial for your medical device clinical trial and when patient compliance is a negligible factor to success of the study. From adverse events to patient compliance My original goal for Flaskdata.io was to use machine learning to predict onset of adverse events […]
