How to measure clinical response in medical device clinical trials
It is 19:15 and daylight savings time. It is too hot to go out and run or bike. Time to write. Today we were helping a customer with hardware issues. At the end of a long day, I started thinking that even hardware issues are valuable data to the decision-making process of measuring efficacy of […]
Bionic M2M: Are Skin-mounted M2M devices – the future of clinical trials?
There is a lot of hype about wearables. One of the best ways to correlate patient compliance with patient biometrics is for the patient to wear the sensor on her skin. I started thinking about skin-mounted devices again after reading the press release about the BioSerenity Series B, so I dug up an essay I wrote […]
The gap between the proletariat and Medidata (or should I say Dassault)
We need a better UX before [TLA] integration The sheer number and variety of eClinical software companies and buzzwords confuses me. There is EDC, CTMS, IWRS, IVRS, IWRS, IRT, eSource, eCOA, ePRO and a bunch of more TLAs. For the life of me I do not understand the difference between eCOA and ePRO and why […]
Obsessed with patient compliance
Obsessed with patient compliance I’m watching a series of short videos done by Techstars founder Brad Feld. Brad talks about founders needing to be obsessive. I am totally obsessed with patient compliance. The key to speed in medical device trials is eliminating non-value-added activities and automating everything else. There are a lot of smart people working […]
How to annoy your eClinical platform vendor
Every question is a cry to understand the world. There is no such thing as a dumb question. Carl Sagan In this guest post, my colleague Tigran Arzumanov asks questions about questions. Tigran is an experienced and highly talented business developer for life science companies and he’s been around the block a few times. What […]
Good strategy bad strategy for study monitors in connected device studies
Friday is an off-day in Israel and I try to work on projects or read. I am now reading Richard Rumelt’s book Good strategy Bad strategy: The difference and why it matters. The core content of a strategy is a diagnosis of the situation at hand, creation or identification of a guiding policy for dealing […]
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 […]
Improving patient compliance to medical device protocols with threat models
To paraphrase Lord Kelvin – “You cannot improve what you cannot measure”. I have about 10′ before Shabbat and I wanted to offer 2 possible approaches for improving patient compliance to medical device clinical protocols. One approach considers the patient as an attacker to the study data. This approach considers social, cost, adverse events, personal, […]
