medical devices

10 free ways to reduce risk in your medical device clinical trial

You cannot outsource quality in your medical device clinical trial Collecting low-quality data means that your trial is likely to fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time. You cannot outsource quality, you have to build it into …

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Temperature excursions and APIs to reduce study monitor work

I did a lot of local excursions the past 3 days – Jerusalem, Tel Aviv, Herzliya and Haifa.   For some reason, the conversations with 2 prospects had to do with refrigerators.   I do not know if this is Freudian or not, considering the hot weather of July in Israel. The conversations about refrigerators had to …

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patient compliance in medical clinical device trials

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 …

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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 …

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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 …

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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 …

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Medical device clinical trials – not for the faint of heart

Patients in medical device clinical trials are on their phones.  On their phones for WhatsApp and for monitoring chronic conditions and reporting outcomes at home, at work and in the middle of a call to their friends. Medtech developers are looking to make their product development process as effective as  possible and are facing conflicting requirements when it …

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