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3 Secrets to Capturing Reliable Clinical Data at Home

clinical strategy market driven innovation regulatory strategy Apr 06, 2022
rwe reliable clinical data home

Written by Eric Sugalski and Ulrich Herken

True story.

A medical device manufacturer developed an at-home wearable defibrillator for populations at high risk of sudden cardiac death. This device was intended to be a bridge – worn for approximately one month until a permanent defibrillator was implanted.

Patients were expected to wear the devices continuously, except while taking a shower. Again, they were at high-risk of sudden death.

A clinical study was conducted to evaluate the effectiveness of this device in reducing mortality. The final analysis showed that 25% of patients wore the device for less than 4 hours per day. 36 patients died not wearing the external defibrillator at the time of their death.

The trial did not meet its primary endpoint of mortality reduction.

With more procedures moving from the hospital to the home, there are new challenges for medical device companies regarding use and data collection.

The Fundamental Challenge

When conducting a clinical trial within a hospital environment, medical devices are typically operated by healthcare professionals. The operators are credentialed, well-trained, and led by clinical management teams to ensure that procedures are routinely performed, the device is accurately used, and resultant data is thoroughly documented. In short, hospital based clinical studies allow for tight control of the study parameters.

Not so when moving clinical studies into the home.

Devices may be used by patients and/or relatives. Training is provided, but the frequency, accuracy, and documentation are all at the discretion of the home user. As you would imagine, the quality and reliability of the data in home-based studies is significantly lower than comparable data captured in hospital-based studies.

Enter RWE

While it may seem that clinical data captured in the home is at a disadvantage, the reality is that this data is more accurate and indicative of real-world use. Clinical efficacy, as demonstrated by a controlled clinical study in a hospital setting, is not representative of what would occur outside of the controlled study. Clinical effectiveness, as demonstrated by introducing the real-world factors that influence device adherence, operation, and reporting is real indeed.

Hence, FDA and CMS have both adopted and encourage the capture of Real-World Evidence (RWE) to assess medical devices and their real-world applicability and effectiveness. This data is now being required in many cases to achieve market access, satisfy post-market surveillance requirements, and open reimbursement coverage.

As trends continue to push medical procedures from hospitals to the home, this trend of RWE will only become more important. There is a significant market opportunity for medical device companies to capitalize on this trend. But it requires a deep understanding of RWE and how to ensure its reliability users in their home environments and the factors that lead to use, non-use, and misuse.

Following are 3 secrets to reliable clinical data collection at home:

SECRET #1: Optimize the User Experience

Patients in home environments expect medical devices to work like consumer products.

Consumers buy and use things that make their lives easier and more comfortable. When foreign devices are imposed on their daily routines, they are avoided, forgotten.

Think weight loss. You are supposed to track what you eat, how much exercise you get, and step on a scale on a regular basis. You are supposed to record your activity in a calorie tracker -- maybe in a notebook, perhaps in an app. That works well for a few days. Then life happens.

Contrast to a smart watch. It shows time, reminds of errands and does other useful things. Some also record activity, heart rate, even oxygen saturation – all without requiring any user action. And if you meet goals, you get rewarded by encouraging messages. A bit of endorphin flows, you are happy, and keep going. Self-reinforcing feedback loop.

Your device needs to be like a smart watch, not a calorie tracker .

From the unboxing experience to the instructions, general operation, cleaning, and any other step – you need to identify and implement the rewards that bring immediate satisfaction – the things that will encourage users to feel the victory in the daily task.

SECRET #2: Embed Accuracy Detection

Users can be trained. You can even require them to listen to audible instructions before every use – probably not a good idea though, if you’re seeking regular adherence. Even with the training and regular instructions, users will still screw-up the device operation and generate unreliable data.

Sure, your training should be thorough, and your instructions should be clear and simple. But in addition to those things, you should embed some type of detection method to determine whether the device is being used properly. This could be, for example:

- Conductance sensors to ensure proper skin contact
- Accelerometers to detect device orientation and movement with the patient
- Algorithms to identify data outside of a plausible range

In addition to detecting improper device use, it’s even more critical to help users understand when the device has been used properly. Remember the endorphin release caused by a smart watch congratulating the user for meeting their exercise goal? You want to reward them for doing the right thing.

It’s more important to provide confirmation when a user has done something right than correction when they have done something wrong. Too many corrections will only increase the odds of non-compliance.

SECRET #3: Integrate Monitoring and Nudging

In addition to accuracy detection, your medical device should integrate some means of determining if too much time has elapsed between events. The events could be usage, charging, calibration.

Gentle nudges indicating when it’s time to perform an activity with the device can help users stay regular and adherent. There’s a careful balance here though – too many reminders can introduce the device to a deep, dark closet where those reminders can’t be heard.
It’s ideal if the data is automatically uploaded into a repository, where clinical management teams can realize any lapses. However, this does add additional steps and costs for wireless connectivity via Bluetooth connections to phones or embedded cellular modems. Determining the right method depends on the patient group, criticality of data, on-call care team availability, and pricing thresholds.

If the data is available, then it may allow a care team to reach out with a slightly more forceful nudge. Perhaps by text, then email, then phone call. If users know that others are reviewing their data, it is more likely that they will adhere to the device and its use. Of course, this is a last resort – it’s much better to create the user experience that implicitly motivates users.

So, Remember...

If you are pursuing an opportunity to move a medical procedure from the hospital to the home, then RWE will be a vital component of your business strategy. However, you need to think this through from the start.

Your RWE home-based data collection strategy will be more successful if you optimize user experience, embed accuracy detection, and integrate monitoring and nudging capabilities. However, bear-in-mind, these features are core elements of your device design, and they need to be conceived, tested and refined at the early stages of product development. Attempting to bolt them onto a design near completion will almost always result in a clunky architecture and poor user experience.

If you need help with RWE the strategy and the product design that will help you collect reliable data, reach out to us at Archimedic. We can help you put the right strategy design in-place and execute to meet your business needs.

Guest Contributor

Ulrich "Uli" Herken is the founder and principal of Quorad – a consultancy focused on medtech research and strategy. Uli has spent over 30 years in medical device research and development, managing pre-clinical and clinical research activities in several start-ups as well as in a corporate environment.

He is a physician by training and worked clinically in emergency medicine, intensive/critical care, and internal medicine. Uli has also held various management positions in medical device companies in the areas of diagnostic and therapeutic ultrasound, and acute critical care (monitors and sensors, defibrillators, ventilators). Uli has worked with US and international researchers on projects ranging from exploratory studies to multi-center clinical trials.

Find more on Uli and Quorad here.

 

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