WatchBP, EBM based Solution Product serving for VBC

Vance Chang
Medical Device Practitioner’s note
6 min readMay 1, 2023

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中文版

This is an important milestone in the history of Microlife. Even amidst changes in ownership, it is worth looking back at its history. Many people think that measuring blood pressure is simple, but healthcare professionals who can measure it correctly may not be as abundant as people think. In short, this product provides reliable blood pressure measurement using standards similar to ISO requirements, which can lead to accurate and systematic management of hypertension, avoiding unnecessary waste in medical resource.

Preface

The founder of Microlife has always been concerned about the ineffectiveness of healthcare and wastage of resources. In addition to participating in healthcare reform activities, the WatchBP solution-type product was also created in response to this context. Currently, no similar product with this concept has been seen in the market.

At the same time, the founder foresaw early on that consumer medical devices would become commoditized and fall into low-price competition. This product was created to differentiate itself in the market.

The foundation of this solution is guideline-based, based on medical guidelines, and is a manifestation of Evidence-Based Medicine (EBM).

Evidence Based Medicine

According to wiki of the following,

Evidence-based medicine (EBM) is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients”. The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management.

And the most concrete manifestation of Evidence-Based Medicine is the creation of guidelines.

Guidelines are developed based on the spirit of Evidence-Based Medicine, using the strongest evidence to provide guidelines applicable to populations, which is also a consensus among all doctors.

However, guidelines are sometimes a process that cannot require healthcare professionals to memorize every step or use a notification to prompt them. Therefore, the most practical way is for medical device companies to automatically integrate these procedures into the device, making it easy for staff to operate, saving time, and providing efficiency.

This product is developed based on the guidelines of the European Society of Hypertension.

2018 ESC/ESH Guideline

Example

According to the current ESH guideline: https://academic.oup.com/eurheartj/article/39/33/3021/5079119?login=false Blood pressure measurement in the clinic requires measuring the blood pressure of both arms, and in the future, measuring the blood pressure of the arm with the highest blood pressure. Blood pressure also needs to be measured three times, with an interval of 1 to 2 minutes between each measurement, and the average of the last two measurements is used as a reference.

ESH Guideline for Office BP measurement

This process may not seem difficult, but if using a regular blood pressure monitor, measuring three times on each arm, a total of six times, would take at least 15 minutes, and there is also a risk of calculation errors. This is also the reason why this process is difficult to execute. If using WatchBP Office, a dual-arm blood pressure monitor, this goal can be easily achieved.

https://www.microlife.com/uploads/media/800×800/05/1335-WatchBP%20Office%20AFIB_front_cuff.png?v=2-0

Accurate measurement is the core

From a technical point of view, integrating these processes into a microcontroller is easy, and many companies can do it, but the most important performance of an instrument is to provide accurate measurement, and this is the main reason why major manufacturers win out. Therefore, the WatchBP series continues Microlife’s accurate measurement algorithms, which not only meet the requirements of basic regulations but also have been clinically validated for accuracy through multiple studies.

In addition, the cuff is also one of the sources that affect accuracy. For larger arm sizes, larger cuffs are needed, and clinical studies have also been conducted to validate different sizes of cuffs.

ESH guideline requires larger and smaller cuffs for larger and thinner arms

From Accuracy to VBC

VBC (Value-Based Care), which is care based on value, is a strategy proposed in recent years in response to the heavy burden of national health insurance and the declining quality of medical care. Relevant discussions can be found in the following link.

In terms of hypertension management, inaccurate blood pressure measurement will lead to a waste of medical resources in subsequent treatment decisions. As mentioned earlier, in the case of dual-arm blood pressure measurement, if the arm with the highest blood pressure is not used, there may be misjudgment and delay in treatment timing, leading to the assumption that blood pressure is controlled within the range. In addition, home blood pressure monitoring is the most important basis for medication adjustment. 722 protocol was prospsed by Taiwan Hypertension Society based on the medical evidence.

When it comes to hypertension management, inaccurate blood pressure measurements can lead to wasted medical resources in terms of subsequent treatment decisions. As mentioned earlier, if blood pressure is not measured on the arm with the highest blood pressure using a regular blood pressure monitor, there is a possibility of misjudgment and delay in treatment. Furthermore, home blood pressure measurements are the most important basis for adjusting medication.

In addition to the difficulty of achieving accurate measurements with a regular blood pressure monitor, accuracy of measurement is the most important factor. In managing hypertension, both clinic and home measurements are necessary. Therefore, three types of blood pressure monitors are used in conjunction: one is the Office BPM used for initial blood pressure measurements during diagnosis and to determine which arm to measure, the second is the Ambulatory BPM used to measure 24-hour blood pressure and diagnose hypertension, and finally, for confirmed or pre-hypertension, home measurements are used for continuous monitoring or to adjust medication based on the data obtained.

2018 ESH Guideline

The specific combination is as follows, and at the time, the opinion of Dr. Thomas G Pickering, a doctor from the American Heart Association (AHA), was also taken into consideration.

Up to this point, it also explains the origin of the product name, “WATCHBP,” which stands for “Whole Aspect for Treatment and Caring for High Blood Pressure.”

Conclusion

This product has been on the market for 16 years and was adopted by the UK’s National Health Service (NHS) because it complies with guidelines. It has undergone modifications, such as the addition of an AF measurement function to alert patients who may have AF, which can cause measurement inaccuracies. Products like this that target VBC are best suited for public healthcare systems such as the NHS or Integrated Delivery Networks (IDNs) that offer both insurance and medical services. In 2011, the author discussed this concept with innovation expert Clayton Christensen, but unfortunately, due to personal career planning and Mr. Christensen’s passing in 2020, the product’s fundamental spirit aligns with Christensen’s views in his book.

It is believed thate such solution will be popluar at the right timing.

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Vance Chang
Medical Device Practitioner’s note

Over 25 years experience in medical & biotechnology industry involving RD, product management, business development, and regulatory affair/quality management.