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 […]
How to become an insights-driven clinical operations manager
In my post Putting lipstick on a pig of eCRF I noted that good online systems do not use paper paradigms. In this post – I will develop the idea of using digital / mobile /automation to become an insights-driven clinical operations manager. Insights-driven clinical operations practices are more important than ever if you want […]
The golden rule for digital therapeutics and connected medical devices
He who has the gold rules. That’s all you need to know when it comes to privacy compliance. In the past 5 years, a lot has happened in the digital health space. Venture funding in 2018 was close to $10BN and a lot of work is being done in the area of digital therapeutics and […]
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 […]
Patient compliance – the billion dollar question
The high failure rate of drug trials The high failure rate of drugs in clinical trials, especially in the later stages of development, is a significant contributor to the costs and time associated with bringing new molecular entities to market. These costs, estimated to be in excess of $1.5 billion when capitalized over the ten […]
Killed by code – back to the future
I hope that the code in your digital therapeutic for treating autistic children, doesn’t look like this. 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). In Jan 9, 2017 FDA reported in a FDA Safety […]
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 […]
