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 […]
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 […]
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 […]
Invisible gorillas and detection of adverse events in medical device trials
What is easier to detect in your study – Slow-moving or fast moving deviations? This post considers human frailty and strengths. We recently performed a retrospective study of the efficacy of Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on […]
Strong patient adherence in real life starts with strong people management
Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device. Like any other industry – success in clinical trials is all about the people. The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians […]
What real-time data and Risk-based monitoring mean for your CRO
A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data. RBM methods used by a central clinical trial monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from […]
The 3 tenets for designing a clinical data management system
Abstract: This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t). Enjoy! The trend of DIY: good for […]
Using AI to assure patient compliance in heart failure patients
Can AI be used to help patients with heart failure? Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in the European Union (EU). CVD accounts for 45% of all deaths in Europe and 37% of all deaths in the EU. In 2015, almost 49 million people were […]
A word to Teva on firing employees and assuring data security
To be able to do something before it exists, sense before it becomes active, and see before it sprouts. The Book of Balance and Harmony (Chung-ho chi). A medieval Taoist book In early December 2017, the Israeli pharmaceutical generics company Teva announced it would lay off about 1,700 of its employees in Israel, who make up […]
The pay-off for reducing cycle time in medical device clinical trials
Well – it certainly isn’t science and technology innovation or even the FDA.At a recent executive roundtable, according to Tufts University’s Center for the Study of Drug Development director and associate professor Ken Getz, it is that many pharma corporations and CROs have not yet fully embraced the newest, most efficient technologies, and this has been […]
