Doctor-Patient Communication – the key to success and the struggle to succeed.

Katherine Murphy, Chief Executive of the Patients Association London once said, “The huge rise in complaints in relation to communication and a lack of respect are of particular concern. Patients are not receiving the compassion, dignity and respect which they deserve.” As clinical trial technology guys, you would assume that we love code more than […]

Urban medical legends

Because I was trained as a solid-state physicist I am skeptical of many medical claims – including the efficacy of digital health apps.  Gina Kolata wrote this post last week.  I’ll let you decide for yourself. You might assume that standard medical advice was supported by mounds of scientific research. But researchers recently discovered that […]

What takes precedence? GCP or hospital network security?

This is a piece I wrote a while back on my medical device security blog – Cybersecurity for medical devices. One of the biggest challenge of using connected medical devices in clinical trials is near real-world usage of devices that are not commercially-ready. We have a couple of customers that are performing clinical trials of […]

Why Microsoft is evil for medical devices

Another hot day in paradise. Sunny and 34C. Not a disaster but still a PITA We just spent 2 days bug-fixing and regression-testing code that was broken by Microsoft’s June security update to Windows operating systems and Explorer 11.    Most of the customers of the FlaskData EDC, ePRO, eSource and automated detection and response […]

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 […]

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, […]

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 […]

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 […]