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NIHON KOHDEN (日本光電) Life Scope monitoring history from the 1990s; In this article we look at the company-wide confusion prevalent in November 2002 such that a new biphasic defibrillation discharge design was launched for export sales without ascertaining its clinical efficacy on human patients. NIHON KOHDEN could not obtain approval from Japan Regulatory Authority for sales of her first biphasic defibrillator in Japan until December 2005 (i.e. three years later).
NIHON KOHDEN Life Scope Patient Monitors Struggling The Disruptive Digital Revolution (IV)
What Not To Do Is Essence Of Strategy
The essence of strategy is choosing what not to do - Michael Porter
| NIHON KOHDEN was stumped by another game changer! |
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The next major export after patient monitors is defibrillators for NIHON KOHDEN CORPORATION. Neurology, ECG, Cell counters etc. only accounted for a small percentage of the export sales for the manufacturer.
In May 1997 Nihon Kohden released a new defibrillator with a semi-automatic AED mode for export using mono-phasic defibrillation. The details of this TEC-2200K series can be found in the 1997 Product Guide.
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| The monophasic CardioLife TEC-2200K series was launched for export in May 1997 |
This was a mono-phasic model using the non-proprietary Edmark single-phase pulse as illustrated and the use of rechargeable battery for energy made it very inconvenient for public use.
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| Edwark, Single Phase Pulse defibrillation waveform used by monophasic CardioLife TEC-2200K series in 1997 |
Just a few months after the TEC-2200 series was released in May 1997, Hewlett Packard made announcement to acquire Heartstream Inc. in a stock-swap deal.
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| Heartstream ForeRunner |
Biphasic defibrillation waveform was becoming the new preference as it allowed for a smaller and lighter defibrillator design; more importantly it uses less current and this means less damage defibrillation will do to the heart. With the deal with Heartstream, HP acquired the Heartstream biphasic technology and also expanded the line of external defibrillators to include lay responders users.
There was zero interest in the monophasic TEC-2200 series defibrillators offered by Nihon Kohden for ex-Japan market and the products had to be withdrawn from exporting.
| The basic concept of a bi-phasic shock energy is to add a negative follow-up phase to the conventional mono-phasic shock to achieve the same defibrillation result using lesser energy |
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| The global shift to biphasic defibrillation technology was an unexpected market disruption for NIHON KOHDEN |
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After more than four years, NIHON KOHDEN remained unable to offer biphasic defibrillators and the company had no choice but to look for a suitable partner with biphasic technology for the Japanese domestic market when the demand for biphasic AEDs emerged. A strategic OEM distribution agreement was announced in January 2002 that Nihon Kohden would market Cardiac Science's line of AEDs under Nihon Kohden's trade name. This arrangement was a big success and many AED-9200 and AED-9231 were sold in Japan as reflected in annual reports and presentations.
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| NIHON KOHDEN CardioLife AED-9200 and AED-9231 were highlighted to have very good sales in FY2006 financial results presentation |
The Cardiac Science STAR biphasic waveform (see white paper) was validated by researchers at Cleveland Clinic and Cedars-Sinai Medical Center in accordance with US FDA guides for Safety and Effectiveness |
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It was however not possible for Nihon Kohden to get any success outside of Japan as it was cheaper for distributors to buy directly from Cardiac Science the original models.
Instead of licensing the design from Cardiac Science, a few engineers in NIHON KOHDEN started to experiment with biphasic defibrillation on pigs and came up with the proprietary Acti-Biphasic defibrillation shock. It was done with minimal external collaboration, the company thus had great difficulty securing the necessary clinical support to advance the number of investigated cases for proper clinical validation. To date, there is not a single clinical paper published on Acti-Biphasic defibrillation.
The Acti-Biphasic waveform is seen as operating in an open loop during the first phase and in a closed loop during the second phase. It is a positive pulse during the first phase and of variable duration dependent on patient impedance. In a closed loop during the second phase, the duration of the width is therefore constant and being set to 3.4ms; it is not clear why 3.4ms constant width during second phase is optimal and why 270 Joules maximum energy is sufficient.
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| The first phase is positive and a wider pulse than the second phase |
The first to use the Acti-Biphasic waveform were the TEC-7700 series defibrillators |
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| The first Acti-Biphasic defibrillators |
| Output of CardioLife TEC-7700K series is consistent with the declared waveform |
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The output waveform of the CardioLife TEC-7700K series on a recorder is as shown below. The recording correctly shows the first phase is a positive pulse.
The recording shows the voltage first swings to the top (positive saturation), then to negative saturation after some time; this is fully consistent with the official description of the Acti-Biphasic waveform.
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| Output of CardioLife TEC-7700K series is consistent with the declared description |
How can we know if the Acti-Biphasic defibrillation shock actually works? |
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| The margin of error is high for data from a small 75 investigated cases |
| Outside of the US market, we must ask what is the point of buying such critical treatment devices and placing them on standby to save lives? It is so unfair to the patients needing immediate treatment in a life-threatening situation! |
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Before proper completion of clinical validation, the company was bold enough to go ahead with exporting the first newly-designed Acti-Biphasic defibrillators from November 2002, relying solely on reputation of being an existing supplier of mono-phasic defibrillators. The November 2002 export launch was three long years from the date Japan MHLW officially approved its use for the domestic market.
The desperate action was taken in response to the rapid changing preference for biphasic defibrillators in the market but the process totally overlooked the seriousness of mandatory successful clinical studies before marketing; the fact that Ministry of Health, Labour and Welfare (MHLW) had not yet approved the sales of TEC-7700 series defibrillators in Japan domestic market reflected the disturbing absence of internal safeguards in corporate conduct.
Up to this point, the company had never exported a new product before first launching it in Japan, showing the company was in complete disarray. It is not just loss of credibility in overseas markets as a leading defibrillator exporter from Japan but a ticking time bomb waiting to explode with important issues left unaddressed.
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| Before completion of proper clinical validation, Nihon Kohden began exporting proprietary Acti-Biphasic defibrillators in 2002 |
| It took Japan Regulatory Authority three (3) long years to finally grant approval for the TEC-7700 series to be allowed for sales in Japan |
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The long three years period implied the application was turned down several times and serious doubts by the Regulatory Authority to grant its use. What prompted the decision to clear it after three years' wait is something we should know. By the time of receiving approval to sell in Japan, many CardioLife TEC-7700 series defibrillator were already exported.
NIHON KOHDEN was only able to announce the launch of TEC-7700 series defibrillators for sales in Japan market on December 1st, 2005.
| When the TEC-7700 series defibrillators had not even obtained approval from MHLW to sell in Japan, a new defibrillator series was launched with undisclosed Acti-Biphasic waveform flipped vertically upside down! |
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Yes, before the TEC-7700 series defibrillators were allowed for sales in Japan, Nihon Kohden had incredibly gone on to launch another Acti-Biphasic TEC-5500 series defibrillators for export sales in August 2004. Why was the need to launch the TEC-5500 series when it was crystal clear the TEC-7700 series application with Regulatory Authority would take time for approval? This made the urgent launch of TEC-5500 highly suspicious and illogical.
| We only learned later that for some unknown reasons, the manufacturer had surreptitiously decided not to continue with the original waveform! |
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This was the series later found to have Acti-Biphasic waveform flipped vertically upside down from that of the TEC-7700 series and it was happening right before Japan MHLW granted approval for the TEC-7700 series.
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| CardioLife TEC-5500K series started to be exported from August 2004, when Japan MHLW had not approved the sales of CardioLife TEC-7700 series |
The Timeline
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| Export of CardioLife TEC-5500K series started in August 2004, more than one year before Japan MHLW actually approved the TEC-7700 series |
| The reason CardioLife TEC-5500 series defibrillators were quickly approved for sales in Japan was based on the principle of declared substantial equivalence with the newly-approved TEC-7700 series |
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Current TEC-5600 series, TEC-8300 series output waveform are similar to TEC-5500 series defibrillators, how about submission documents for foreign regulatory approval which are all based on the TEC-7700K series? We also could not help wondering if the domestic and export versions of the Acti-Biphasic shock energy are currently identical?
A prestigious University Hospital in Taiwan was the first to find the polarity of TEC-5500K output waveform inverted from the original shown on the manual
In the image below, we were greatly puzzled to learn of an adverse report from a competent Biomedical Engineering Team in National Taiwan University Hospital (Taipei City) that the polarity of measured waveform from two tested CardioLife TEC-5500K series defibrillators were inverted (i.e. opposite in polarity) from what the manuals had described. The tests were a result of investigation after a serious performance failure incident. The investigation raised many questions and only the IEC60601-2-2:2002 electrical safety compliance was put to rest.
There was no doubt since they had tested both models TEC-5521K (S/N 09xx4) and TEC-5531K (S/N 05xx4) to arrive at the same conclusion; the suffix K is for export models using English language as interface (for example the suffix J is for Japan domestic models), indicating more than 9000 units of TEC-5521K and more than 5000 units of TEC-5531K had been produced before the two tested units respectively. Detailed comparison was also done with defibrillators from another manufacturer (Philips) using the same testing equipment (Fluke Impulse 7000DP with 7010 Selectable Load) and the polarity was consistent with the manual descriptions of Philips.
This was an input from professionals that the Acti-Biphasic output waveform from the CardioLife TEC-5500K series defibrillators starts with a negative polarity and ends with a positive polarity; it is the exact opposite of what were shown on the operator and service manuals. As far as we know, there is no known manufacturer with a biphasic waveform that starts with a negative polarity, NIHON KOHDEN is unique in this approach but there is no clinical research done to validate its use on patients!
The next image showed the illustration from another distributor (Thailand) sending in a Nihon Kohden defibrillator analyzer AX-103VK (OEM device) for repair.
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| The AX-103VK defibrillator analyzer has a wave output on the rear panel for oscilloscope display |
The analyzer was concluded by their technical staff to be defective because the display on the oscilloscope was inverted; the analyzer was of course working fine. Said distributor had sold the highest number of CardioLife TEC-7700K series defibrillators in the world and knew too well the "Correct Graph", confident of the defect conclusion. The conclusion turned out to be erroneous because the service manual wrongly informed them a TEC-5500K series defibrillator has similar output as a TEC-7700K series defibrillator.
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| Changing "Evaluation machine" from a TEC-7700K defibrillator to a TEC-5500K defibrillator |
| Does the inverted waveform only apply to production batches meant for export? |
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Trying hard to prolong the life of the legacy Multi-parameter Unit
| Why the pain of two missing connector sockets to gain the use of one flexible socket? |
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In 2001, a popular Life Scope BSM-2301K (also known as Life Scope i) was launched and many customers bought it for standalone applications not restricted by system compatibility. It was popular because the Life Scope BSM-2300K series range of monitors were the first in the industry to adopt the new-generation type 8.4-inch high-resolution touchscreen introduced by the electronics industry. The new touchscreen display was a huge jump in touchscreen technology and made for highly-intuitive operation.
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| The portable 8.4-inch Life Scope i (BSM-2301K) |
In a puzzling move, the Life Scope BSM-2301K monitor makes use of a MULTI-parameter Unit with only one yellow MULTI socket for three types of measurements, namely:
a. Invasive Blood Pressure
b. Thermistor Respiration
c. Digital self-contained mainstream CO2 serial kit sets.
The MULTI socket does not mean flexibility because you can only do one of the above parameter at any one time. Common sense tells us three dedicated sockets is far superior; why suffer pain of two missing sockets to gain use of one flexible socket?
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| Life Scope-i does not have enough connector sockets |
| NIHON KOHDEN could not justify use of the MULTI sockets |
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The flexible MULTI socket argument is downright unconvincing when the monitor comes with one dedicated Temperature socket. Why is the monitor not using the MULTI socket to access the Temperature hardware if sharing is good? It tells us the manufacturer is fully aware sharing makes for inflexible monitoring.
There are two parts to the hardware in the Life Scope BSM-2301 bedside monitor.
(a) The hardware sharing the one yellow MULTI socket in the Multi-parameter Unit:
- 1 channels of IBP
- Thermistor Respiration
Note: The mainstream CO2 comes in the form of a self-contained serial kit set, utilizing the MULTI socket only as a serial port
(b) The hardware using dedicated connector sockets, external of the Multi-parameter Unit:
- 1-ch TEMP
- ECG
- SpO2
- NIBP
The reality was the flood of complaints from users insisting the single MULTI connector socket on the BSM-2301K was not enough. The manufacturer was pressured to respond with an updated model (BSM-2303K) with an isolated MULTI socket added. The isolation was done so as not to disturb existing Multi-parameter Unit with an additional MULTI socket. It means the additional MULTI socket is not a functional MULTI socket.
The isolated MULTI socket is solely for IBP monitoring, effectively relieving the MULTI socket of existing MPU to only measure either Thermistor Respiration or act as serial port for the mainstream CO2 kit set. The solution was only partial, and it reduced two missing sockets to one missing socket; a total solution would have been just using dedicated sockets as there is no need for socket sharing.
There was no actual demand for additional IBP channel, but the BSM-2303 bedside monitor was camouflaged as an upgraded monitor with 2 channels of IBP.
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| Under pressure, an additional isolated MULTI socket acting solely as an IBP amplifier had to be introduced |
You will find important facts being withdrawn from later monitor manuals |
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BSM-2301 (Life Scope-i) Service Manual is clear on the design; manuals for later models stop providing details.
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| Block diagram on BSM-2301 (Life Scope-i) Service Manual |
The success of the BSM-2300 series was short-lived since touchscreen technology was not proprietary and it just prompted every patient monitor manufacturer on earth to respond to the popularity of touchscreen technology, with Philips as the most aggressive. Philips product range is wide, most models also had a non-touchscreen version preferred by some users; the approach by Philips greatly segmented the patient monitors market and presents a major challenge for Life Scope monitors with only a limited product range. The problem is even larger if other range from Philips such as Goldway, Efficia etc. are taken into consideration.
The configured Life Scope BSM-2300 series was succeeded by the 10.4-inch Vismo series configured multi-parameter monitors, as well as configured Life Scope VS (BSM-3000) series monitors using bigger 12-inch and 15-inch screens. The later series monitors stubbornly keep the MULTI sockets, for a reason that will become clearer later in this article.
Steer Clear! There is no customer value created by time-sharing cheap connector sockets
Elaborate time-sharing are applied to things that are expensive (therefore rare), and not worth the efforts for things that are cheap (therefore plentiful) like connector sockets! It only makes economic sense to see productive efforts being made to time-share a CPU, a car, a hotel room, a yacht, an airplane but not a calculator, a pencil or a pair of scissors. The legitimate resources for a patient monitor to time-share are obviously the amplifier hardware and not the connector sockets or switches; this way there would not have any idling costly hardware leading to inefficient use of valuable resources!
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| Time-sharing of an expensive hotel room creates value for the customers but time-sharing of a cheap connector socket does not |
The next picture shows another manufacturer time-sharing one channel bio-amplifier hardware between IBP and Temperature measurements, but not any connector socket; this is exactly the opposite of what Nihon Kohden is doing. The said manufacturer merely ensures physically it is not possible to make use of both the PRESS and the TEMP socket at the same time.
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| Time-sharing of expensive hardware, not the cheap sockets |
| The dangerous use of semi-quantitative estimation data for uncertain measurements and concurrently displaying a flawed CO2 waveform |
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NIHON KOHDEN lacks side-stream CO2 sampling expertise and buys OEM units to offer them as expensive standalone. The AG-400 CO2 unit as shown, for example, is technology from Oridion Medical. For monitoring such as post-surgery recovery, integration of the side-stream CO2 into the monitor is a mandatory requirement because an external unit requires additional power socket besides necessitating the use of a trolley.
For some unknown reason, Nihon Kohden monitors could not offer integrated side-stream CO2 unit.
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| The inability to integrate the sidestream CO2 unit into the patient monitor main unit |
Nihon Kohden solution was to offer miniaturized mainstream cap-ONE TG-920P CO2 sensor kit (order code P907) that can be used on non-intubated patients.
The cap-ONE TG-920P CO2 sensor kit (order code P907) has very small sensors because semi-quantitative measurement is adopted, the method is not commonly seen and many are not alerted to the risk of using data from semi-quantitative etCO2 kit sets for critical measurements and true CO2 waveform display.
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| Nihon Kohden cap-ONE P907 (TG-920P) mainstream CO2 sensor kit |
| Is it easy to remove the disposable adapter from the two tiny transducers after use? |
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When the sensors become smaller, it also means the disposable adapter becomes relatively much bigger as seen in this below picture. When trying to remove the disposable adapter from the transducers, it is difficult to separate the two because of the latching mechanism. A small size transducer means anything that latches onto it must be even smaller.
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| It is not easy to separate the disposable adapter from the Cap-ONE transducers after use |
When removing disposable adapter from the mini sensors, users tend to just pull from the cables and this action quickly weakens the joint holding the sensors and cables. The action will cause stress to the two joints and quickly degenerate the performance of the transducers.
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| Users just doing the inevitable |
Shown below is another TG-900P etCO2 kit set (order code P903) that makes semi-quantitative CO2 measurements; the TG-901T3 kit set (order code P906) is the same thing using a different connection plug. The medical devices from same manufacturer that uses semi-quantitative etCO2 kit sets for patient CO2 waveform monitoring have Life Scope patient monitors, Vismo patient monitors, Cap-STAT OLG-2800, CardioLife defibrillators and Neurofax EEG machines etc.
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| Nihon Kohden semi-quantitative etCO2 kit sets |
| A highly relevant question: Can users accept estimated measurements for patient monitoring? |
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To save costs, the semi-quantitative kit sets do not make measurement during the inspiration phase, the measurement duty cycle is as shown. This means semi-quantitative CO2 measurements are not made continuously.
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| Semi-quantitative means there is a duty cycle, and measurement is not continuous |
Semi-quantitative measurement is also of low-accuracy type, performed using one IR detector instead of the usual two to save cost. This is reflected in the measurement tolerance.
Contrasting, quantitative measurement delivers high accuracy for critical care. To ensure the necessary high accuracy, quantitative measurement employed two IR detectors for simultaneous CO2 measurements at different wavelength for results comparison. CO2 measurements are also being made continuously.
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| Quantitative measurement employs two detectors to make continuous measurement at different wave-lengths to compare readings for high accuracy |
NIHON KOHDEN specification for TG-901T CO2 sensor kit shows even the specified low accuracy of CO2 measurement using semi-quantitative method no longer holds true once CO2 is present during the inspiration phase.
This is because actual CO2 value will be more.
| As seen from the duty cycle, there is no measurement being made during the inspiration phase; how can users know specified measurement accuracy is valid? |
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| Measurements are invalid when CO2 is present during inspiration, but CO2 is not measured during this period; can you have confidence in the measurements? |
The users are also not alerted on screen there is no CO2 measurement being made during the inspiration phase, and unknowingly made to take an unnecessary risk.
| Semi-quantitative methodology means cost-effective estimations and the design cannot be used in a general way, only on a selective basis with known risks |
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For example, semi-quantitative methodology can be used as a simple estimation tool for obtaining the numerical value of End-tidal Carbon Dioxide level (etCO2).
Below picture shows the semi-quantitative method in the way it was intended for, estimating only the etCO2 numerical value for purpose of airway tube placement confirmation. It is not for continuous waveform display.
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| A hand-held semi-quantitative etCO2 estimation tool (with SpO2) for airway tube placement confirmation |
| How is it feasible to display a true continuous CO2 waveform when the semi-quantitative measurement kits do not have the ability to make continuous measurements? |
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NIHON KOHDEN also allows data from semi-quantitative measurements to be displayed on screen with the non-measurement period reset to zero level. The insistence to display a continuous waveform using discontinuous measurement data from semi-quantitative mainstream CO2 estimation kits is unacceptable; the manufacturer is just subjecting the monitored patients and users to dangerous misinterpretation risks.
A zero CO2 reading on the waveform means zero measured value. No measurement can only mean a defective sensor, not by design!
Note the etCO2 value shown is also not alerted as estimated etCO2 only.
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| A flawed CO2 waveform with non-measurement intervals reflected as zero measured CO2 value |
| As seen from the two true CO2 traces below, expiratory upstrokes do not always start from zero CO2 level! |
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| Quantitative measurements confirming expiratory upstrokes do not always start from zero CO2 level |
Check the latest updated table to make sure you only use quantitative method for critical measurements and true CO2 waveform display on screen.
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| Use only quantitative method for waveform display; the quantitative TG-950P (P905) shown here was already discontinued. |
| How about fully-quantitative type miniaturized mainstream CO2 sensor? |
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| The miniaturized CO2 sensor is easily broken by the bigger and stronger adapter |
In addition to the dead space problem, they had not foreseen miniaturized mainstream CO2 sensors could be easily broken by the disposable adapters. This happened because the disposable adapters are now relatively bigger and stronger!
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| These are common defects of a TG-970P CO2 sensor kit (P909). The design is impractical. |
| Undeniable confirmation the fragile miniaturized CO2 sensor is of poor design, and easily broken |
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| Key point is, it does not last |
^^^