The document discusses the author's experience with medical device regulation in Germany and their work introducing various new cardiac devices. It describes how the author helped companies obtain certification for devices under the new German regulations and sometimes took on distribution roles. Several early cardiac devices and technologies are discussed, including pacemakers, catheterization, ablation, and lesion mapping systems. However, some projects faced challenges, such as issues with patents, clinical adoption, or company acquisitions. The author's work in this area eventually led them to found their own medical device company.

1. Self Employment:
After having finished the employment with Medtronic Northern Europe I continued to work for
almost 2 years as a consultant to Medtronic. In these years I did all the certification jobs
required by the new regulation MedGV (medical device regulation). This included not only
the pacemakers, defibrillators but also all the new products Medtronic was introducing in the
market. There were mechanical and biological heart valves and angioplasty catheters. In
order to get into this high priced catheter market Medtronic had to acquire a company. This
was part of the diversification process started by Medtronic, Minneapolis.
The certification process was essentially a technical test procedure.
Remark: As stated before I was in contact with the initiator of this new regulation. He didn't
want to get the TÜVs involved knowing that the procedure used in the US (the GMP)
reassured the customer that the companies producing those products really cared very much
for quality. However, in order to get the regulation approved by the parliament he had to go
this route. He knew in advance that the TÜVs would never be in a position to really test those
products.
My approach was different. Instead of delivering those products to the technical departments
of the TÜV I invited the responsible TÜV engineer to accompany me to the respective
facilities of the manufacturer to get acquainted with the procedures used to reassure the
quality of the products. Thus, I had to travel quite a bit. This cooperation with the TÜV
continued for quite a while. In course of the years the german medical device regulation was
considered as a valid tool to be used in all of Europe. This led finally to the Medical Product
Law which is now valid in the whole of Europe. However, in order to get all the countries to
sign in to this law the requirements had to be lowered compared to the original regulation.
That - on the other hand - led to the situation that the German authorities considered this law
to be too weak and thus Germany introduced the "Betreiberverordnung" (a supplemental
regulation requiring the consumer to check (or get checked) the medical devices being used
in a hospital on a regular basis).
The regulation did hit especially the american manufacturers of medical devices. Thus, I was
approached by a lot of companies to achieve the certification mark. Therefore, I decided to
move my office near to the TÜV I was cooperating with - the TÜV Bavaria. The place I
picked was Herrsching at the Ammersee.
Due to my job with Medtronic I knew most of the top cardiologists of Germany and of the
part of Europe I was responsible for. Many of them had a cooperation going on with a
medical device manufacturer from all over the world. Due to this new regulation it was not
possible anymore for a german physician employed by a hospital to continue to cooperate
with this manufacturer without a certification issued by one of the TÜVs authorized by the
respective board of the german economy ministry.
As a consequence I was contacted by a lot of those physicians asking for help. I was really
surprised to find out how much was going on on cooperation with german physicians. I just
knew the ones cooperating with Medtronic and that was already a lot. Thus, I was in a very
special position. I got informed about a lot of very interesting new products unknown to the
cardiology community.

2. During my time with Medtronic I had already started to develop accompanying technical
devices to the Medtronic line of products. One of them was a battery powered device to read
a certain signal from the dual chamber pacemakers - the marker channel.
Pacemakers started out as a life sustaining device. They were designed to help people with
a complete AV block. People with this problem have a low ventricular heart rate and
therefore are forced to be very inactive. The first pacemaker solved this problem by
supplying a brief shock to the heart muscle of the ventricle every second (heart rate 60
beats/minute). This type of pacemaker is called a VOO (where "V" stands for ventricle, the
first "O" stands for nO sensing and the second "O" stands for nO inhibition). The market for
this type of pacemaker is quite low and therefore not really a business. There are however a
lot of cardiac problems aside from total AV block which needed to be addressed. However,
those cardiac disturbances needed a different type of pacemaker; one which could sense the
intrinsic signal of the heart and then inhibit a pace. This type of pacemaker is called a VVI (it
means the pacemaker can pace the ventricle, it can sense the intrinsic heart rate in the
ventricle and it can inhibit the pace into the ventricle). This type is still the most often used
type of pacemaker worldwide. (Note; the electrical signal is delivered to the heart by a
conductor placed in the apex of the right ventricle).
A pacemaker has to be controlled on a regular timescale. There are several reasons for that
(e.g. observing the end of life criteria and regular check-ups). In order to do that the ECG of
the patient has to be recorded. It is simple to realize the function of such a VVI pacemaker.
The manufacturers of pacemakers developed new more sophisticated pacemakers for the
treatment of other cardiac problems. The german heart surgeon Hermann Dietrich Funke
developed the dual chamber pacemaker manufactured by Medtronic. This pacemaker has in
its modern version the code DDD (that stands for pacing and sensing in the ventricle and in
the atrium and inhibiting).
The dual chamber pacemaker is usually used in patients who don't get the natural ignition
spike delivered to the ventricles. Those patients do suffer from a temporary or complete AV
block with a well functioning sinus node. The sinus node is located in the right atrium and
determines the heart rate. The spike is usually conducted to the ventricle via the Atrium-
Ventricle border. The function of such a pacemaker can be quite complex and very often the
cardiologist examining a patient with such a pacemaker cannot realize the way the
pacemaker functions. There is especially one problem which can create a life threatening
situation - the activation of a pacing action due to the recognition of a retrograde excitation.
The retrograde excitation can cause the pacemaker to stimulate at a high heart rate leading
to a ventricular tachycardia which can be deadly.
The Medtronic dual chamber devices had a feature - the marker channel - what clearly
showed how the pacemaker functioned. The signals sent out by the pacemaker distinguished
between pacing and sensing in both chambers (atrium and ventricle), however this feature
was not accessible with the programmer supplied by Medtronic to the customers. In order to
push the sales figures of those dual chamber devices I developed a device which could get
this channel out and print it out simultaneously with the ECG tracings. With the help of the
marker channel it was much easier for a cardiologist to understand the ECG produced by a
dual chamber pacemaker. It needed a lot of work to convince Medtronic to incorporate the
marker channel in their programmers but the positive feedback from the customers
convinced the responsible managers in Minneapolis to incorporate the marker channel in the
new generation of programmers. Medtronic introduced in the '80s a dual chamber

3. pacemaker with anti- tachycardia functions. Without the possibility to extract the marker
channel an interpretation of the ECG created by this type of pacemaker would have been
extremely difficult.
Anyway, I had helped some cardiologists and heart surgeons in realizing their ideas by
developing external devices. This was known in this market and thus it was not too surprising
to be contacted by physicians to help them.
One of those projects was a device manufactured by a small company Corazonic located in
Oklahoma City. A physician from the university of Heidelberg introduced me to the product.
He had spent some time at the university hospital of Oklahoma City and was a friend of Dr.
Berbari. Dr. Berbari had researched a special cardiac situation - the silent myocardial
infarction. Whenever a patient has a myocardial infarction (a silent one or a recognized one)
which isn't treated within 3 hours after the event will have a scar (dead tissue) left in the heart
muscle. The propagation of the excitation wave (coming from the sinus-node) has to go
around this scar and sometimes this situation can lead to the result that a retrograde
excitation starts leading to the situation known as "sudden death". He had initiated the
construction of a device to detect traces of such an event - the high resolution and high
amplification ECG system called Predictor. The device treated the ECG signal as a physical
signal. It was recorded with a resolution of 2000 bits per second. This signal was completely
different from the regular standard ECG. By using the Predictor system he found weak
signals at the end of the regular QRS complex. These signals were called "late potentials"
and were caused by the "detours" the excitation wave has to take in cases with an untreated
myocardial infarction. The technique fascinated me right away and I visited Corazonic in
Oklahoma CIty. I started a clinical trial according to the MedGV regulation. The success was
very good. Prof. Breithardt, head of the Internal Medicine at the university of Münster
promoted the use of the device. However, there were real problems with the device and the
software. The technical realization wasn't optimal to put it mildly. I initiated a complete testing
of the product leading to the result I had already guessed. The use of the device could cause
bad side-effects due to the missing safety features required in a system to be connected via
single-use electrodes to the chest of the patient. In addition, the patent issue with respect to
the software was not clear. There was another physician, Michael Simson, who had
developed in cooperation with the company ART a device allowing to do a Late Potential
Analysis. However, the patent issue was never clearly resolved and several companies later
on incorporated a Late Potential Software in their devices. The company Corazonic went
broke over the patent issue with ART. However, the idea of finding out about the detection of
a critical heart condition by using a device capable of doing a high resolution and high
amplification ECG triggered me to develop such a device which would meet the safety
requirements needed to use the device without running the risk of being pursued by the
authorities. The name Predictor perfectly fitted the name of the device and since Corazonic
hadn't protected the name I used it - after having achieved the legal protection (TM) for the
device built by me. This device became a standard in almost all university hospitals of
Germany and in those hospitals specialized in cardiology. Due to the variety of devices being
offered to the customers Prof. Breithardt and the important researchers of late potentials
published a standard for the measuring and evaluation of late potentials. This standard was
based upon my Predictor system. We improved the system over the years and added
several software packages e. g. Heart Rate Variability, Baroreceptorreflex-Analysis etc.
Most of those companies which approached me for getting the approval to sell their devices

4. in Germany didn't have a distributor in Germany. Thus, quite often I got asked to take over
the distributorship. In some - technically ambitious cases - I took the distributorship.
The german federal tax institution reminded me that the main part of my business had shifted
from consulting to selling and that therefore I should change to the appropriate business
form.
Thus, I founded the company Dr. Kaiser Medizintechnik GmbH in 1991. This company
existed 11 years. During this time I introduced several high tech products in the market;
among others a mapping system based upon the work of Mark Josephson, one of the
outstanding cardiologists alive
The university of Münster did buy such a device (Cardio Mapp) and whenever a procedure
had to be done I was called in to handle that system. Using the system properly did allow to
locate the focus on the heart muscle what caused the life-threatening tachycardia. This
device needed single-use jackets. Every one of them was hand-made and thus quite
expensive. Since I had the distributorship (Prucka Houston, TX, was the manufacturer) the
use of this device could have developed into a real nice source of income. However, in one
of the academic sessions during the European Cardiology Congress in Barcelona 1992 this
technique was abandoned in favor of the implant of a defibrillator.
The same company had introduced a device to do electro-physiologic investigations (Cardio
Lab). There were only a few really good centers doing this kind of investigations (among
others Prof. Breithardt and coworkers; Prof. Kuck and coworkers). These groups used
systems partly modified by the users and kind of clumsy. The Prucka system was highly
sophisticated and needed time and effort to get used to it. This prevented the fast success. I
could only sell a few devices. As it is quite often happening in that business the small
companies with the original new ideas impress the big companies and very often the small
companies look for a company which takes them over and pays a substantial amount of
money to the owners of such a company. That happened in case of Prucka and another
company got the distributorship. These events are disappointing but normal. It didn't change
my opinion of the field. Cardiology always fascinated me and it is still important for me.
The swiss cardiologist A. Grünzig - working in Atlanta, Georgia - developed a method to
open partly occluded coronary arteries. This happened in the late '70s. This method had
enormous potential. The use of the new method reduced substantially the number of
surgical bypass procedures.
He inserted a special catheter (balloon catheter) into the coronary artery and moved the tip
of the catheter through the part of the artery which was occluded. Then he pumped up the
balloon and the plaque occluding the artery was pressed into the wall of the artery. This
method was soon used all over the world and it is still the most often used procedure in
cardiology. However, this method could only be applied if the artery was partly occluded. It
didn't work in a completely occluded artery. Patients with completely occluded arteries didn't
profit from this method.
This disadvantage triggered the search for a technique which could open completely
occluded arteries by means of a catheter. I still remember the presentation of a physician
using an Argon Laser to open up a totally occluded artery in a leg. The presentation was
given at one of those world congresses like American Heart or American College.. The name
of the company supplying the Argon Laser was GV Medical located in the Twin Cities,

5. Minnesota). The pictures shown in that presentation were impressive. The laser removed the
material blocking the artery quite easily. I had a long conversation with this physician and he
convinced me that this laser could also be used in the coronary arteries. I got in contact with
the company and I got the job to get this laser being certified. I was really interested in the
use of this laser. I achieved the certification of this laser and I introduced this laser to a
cardiologist at the university of Heidelberg whom I considered to be qualified enough to use
the laser correctly. I invited the physician who gave the presentation to Heidelberg to
demonstrate the use of the laser (unfortunately I don't remember the name of this physician
anymore). He did some procedures and all the cardiologists were quite excited. The hospital
decided to get this laser. I financed in advance the laser. This was one of my worst mistakes
as a business person. In case the cardiologist I had in mind doing the work would have used
the laser I am sure it would have been a success however someone else higher in the
hierarchy took the laser and used it. He wasn't qualified to use the laser. He tried to use it in
the coronary arteries and he did burn holes in the arteries putting patients at risk. He made a
publication stating that the use of such a laser isn't recommended for treating patients with
totally occluded coronary arteries. That was the death sentence for the device. It was never
used again in Heidelberg and I was stuck with an enormous debt almost leading to the
bankruptcy of my company.
There was another company - Neuromed - located in Fort Lauderdale, FL, which approached
me to get their line of products - neurostimulators - approved. I achieved the MedGV
approval and I was again asked to take over the distributorship. I accepted the offer and
started to sell the devices. This put me in a somewhat awkward situation because Medtronic
had also a line of neurostimulators. However, I had never to do with this line of products as
long as I was employed with Medtronic. Therefore, I had no problem selling those products.
Many neurosurgeons knew the products of Neuromed and considered them superior to the
Medtronic equivalents. It turned out that selling those products assured a steady flow of
income. Unfortunately, those situations are not going on forever. Neuromed got into a
problem with the FDA (Food and Drug Administration - american control institution). This
organization is extremely powerful and can initiate the closing of a firm which tries to mislead
this organization. Neuromed did that and was closed permanently.
The boss behind Neuromed was a real clever entrepreneur. After having lost the company
Neuromed because of misleading the FDA he started a new company called NICE. He
approached me again for the approval of this product. NICE produced an implantable
neurostimulator similar to the system TIME produced by Neuromed. However, the really
fascinating issue was the usage of this device. It was designed to be part of a surgical
procedure called Gracilis procedure. There are many patients who have a non-functioning
sphincter due to the removal of some colon material. Those patients need a STOMA pouch.
The really exciting aspect of this procedure was to train one muscle - the Gracilis muscle - to
act as the new sphincter muscle. The training was done in the body of the patient. The
surgeon had the task to locate this muscle near the knee and stimulate this muscle for a
couple of weeks constantly that this muscle changed its property. Once that was achieved
the muscle was cut at the knee and was wrapped around the sphincter. The NICE stimulator
was abdominally implanted and used to stimulate this muscle. In the event of needing to
open the sphincter the patient just had to place a permanent magnet on top of the NICE
stimulator and the stimulation was stopped. I started selling this procedure and it was a really
successful business (especially at the Charite Berlin, the St. Marien Krankenhaus, Berlin,
and at the university hospital Heidelberg) They achieved fantastic results. However, FDA

6. stopped this business, too. I had realized that the cooperation with these companies
contained some risks. Therefore, I had started to develop a neurostimulator. I cooperated
with a known specialist working at the university hospital Cologne. It was a stimulator which
consisted of two parts - one had to be implanted and the other part was outside the body and
contained the energy source - a 9Volt battery. The handheld part contained the software and
an induction coil. The implantable part had an induction coil, too. By placing the handheld
part over the implanted part the patient could initiate a train of stimuli found by testing in the
hospital to be effective. The stimuli had to be delivered to the spinal column by means of an
electrode. I had founded a company in Arizona called Neuroconcepts LLC. This company
should actually produce the stimulator. Then I run into an unforeseeable problem. The
electrode needed to conduct the stimulus to the spinal cord needed a tube like insulation. My
choice was silicon. However, just at the time I was pursuing this project silicon got into the
news due to problems with breast implants. I needed an approval by the german testing
institutions. Otherwise it wasn't legal to sell the product. Due to the public scare the use of
silicon had caused the german testing institutions got extremely cautious and they wanted to
do all possible test procedures. I got the feeling that none of these testing places dared to
come to a positive decision. However, of course they appreciated the business. All of these
tests were extremely expensive. Thus, I made the decision to stop the project. I had invested
a lot of money and had to concentrate on other options.
In addition, the high time of non-invasive investigations in cardiology were over, too. The
invasive techniques had taken over because they didn't take as much time as the non-
invasive ones and these techniques got much better reimbursed. Nevertheless, there are still
a remarkable amount of physicians using our equipment.
The switch from 1999 to 2000 was a somewhat good period of the business due to the many
replacements of PCs to be done. Despite this improvement in business success Ihad
already adopted a resolution to terminate this type of business and to start something
different. Thus, the Dr. Kaiser Medizintechnik GmbH was liquidated in 2002.
My plan was to open up an office on the island of Rügen located in the Baltic Sea which
should conduct health checks using the non-invasive techniques I was very familiar with. The
island of Rügen was the top vacation spot of the DDR before Germany got reunified. After
the reunification a lot of inhabitants of the western states of Germany spent their vacation on
Rügen - approximately more than 3 Million people per year. Assuming that more than 40
percent of all the visitors - usually families with kids - suffered from high blood pressure I
thought that the ones concerned with their health would take the chance to do such a test. In
order to install this office I needed a lot of approvals by government organizations and
professional bodies. It was difficult to achieve but finally I succeeded. I opened my first office
in Binz, the center of activities on the island of Rügen. I called the company "Herz-Kreislauf
Computerdiagnostk. The legal form was a GmbH. (Herz-Kreislauf Computerdiagnostik is
best translated as Heart and blood circulation analysis by means of computer controlled
medical devices equipped with problem oriented software)
I advertised the institution in different ways and we had customers using the facility. I am still
very proud about the results achieved in the years we operated this office. We helped many
people to get the right treatment. We diagnosed the sickness and depending on the nature of
the sickness we advised them to contact hospitals I was known in.

7. Although we had convincing results the number of people consulting us stayed far behind my
expectations. In order to finance this "hobby" of mine we had to sell something else.
I once was visiting Prof. Meinertz at the university hospital Eppendorf (Hamburg). I was
approached by one of his assistants who asked me whether I would be able to configure a
system allowing to conduct a tilt-test procedure in a more qualified way than what was
available at that time. He told me that almost 2 % of our population is affected by a difficult to
diagnose sickness - the sudden unconsciousness (medical syncope). It can happen to
almost everyone that he/she collapses suddenly where ever he/she may be. This is caused
by the fact that the baroreceptors suddenly stop to control the diameter of the arteries and as
a consequence the blood gets into the legs and the brain is empty causing the
unconsciousness. Most patients suffering from this problem get the wrong treatment. This is
even understandable. Falling down that suddenly usually goes along with an injury like head
cuts which have to be medicated by a surgeon specialized in treating accidents. Thus, these
patients seldom see a neurologist or cardiologist who would be better qualified to recognize
the reason of this event.
From a technical aspect the tilt table test is the right thing to do. (Explanation: a tilt-table test
needs a table which can be tilted. The patient is fastened to this table n an upright position
and the table is tilted a little bit backwards. If a patient once had a syncope and he does the
tilt table test it can be expected that after staying in this position for around 30 min the patient
runs into a syncope. In order to minimize the damage to the patient the conducing physician
is tilting back the table into a position with the head below the horizontal level thus allowing
the blood to flow back into the brain). However, this test is extremely time consuming and the
reimbursement by the health agencies is low. In addition, it requires the use of a beat-to-beat
blood pressure measuring device. Some hospitals did a remarkably laborious procedure by
measuring the beat-to-beat blood pressure using the invasive technique usually only used
during a severe surgical procedure. This procedure can only be done by a team consisting of
an experienced physician and well trained nurses. One of these hospitals is the DKD
Wiesbaden.
I attended once some of those tilt-tests to recognize the problems. The worst case is that the
patient running into the unconsciousness acts unpredictably and may hurt himself. Thus, the
use of the invasive technique isn't really advised.
I checked the market searching for a device which allowed to register the beat-to-beat blood
pressure in a non-invasive fashion. I found a device manufactured by the Japanese company
COLIN. The company offered two models which allowed to do that. However, those systems
were designed for a different purpose. The systems were accepted (e.g. by the FDA as the
only system to do that) as a replacement for the invasive beat-to-beat blood measurement in
intensive care units. The critical point using this device for a tilt test was that the sudden drop
in systolic blood pressure caused the device to calibrate. This in turn caused that the
recording of the blood pressure was interrupted thus leading to a valueless recording. It took
me more than a year of intense communication with the technical department of that
company to convince them to modify the software for the application I wanted to use the
device for. I finally succeeded and I got a software which didn't calibrate at the instant the
blood pressure dropped. Thus, it was possible to record the change in blood pressure very
accurately. I did an experimental setup at the DKD using the non-invasive COLIN system at
the same time as the invasive blood measurement was executed. The result was extremely
positive. That lead to the sale of such a system to that hospital. The tilt-table investigation is

8. not only time consuming it also requires a recording of the values measured. Usually, the
time isn't available to do a correct manual recording of these values. Thus, we developed a
software which recorded the ECG and the course of the beat-to-beat blood pressure on a
hard disk. In addition, the software is capable to produce a clear picture of the measurement
allowing a physician to come to the correct diagnosis. The combination of this blood pressure
device and the Predictor ECG system did reduce the time of the physician being at the site of
the test. The test can now be conducted by a trained nurse thus saving valuable time of the
physician. Unfortunately, as happened before to me, the company COLIN got broke and I
couldn't get those devices anymore.
The fact that the health check wasn't accepted as expected and that the availability of the
COLIN blood pressure measuring devices was terminated led to the decision to liquidate the
company founded on the island of Rügen - the Herz-Kreislauf Computerdiagnostik GmbH in
2008. In order to satisfy the requirements formulated in the "Betreiberverordnung" - the
German supplement to the MPG (Medizin Produkte Gesetz) and enforced by governmental
agencies led to the foundation of a succession organization of the Herz-Kreislauf
Computerdiagnostik GmbH. This succession organization is doing the maintenance and
service on the medical systems sold by the companies directed by me to hospitals. There are
no sales activities anymore and I am now officially in retirement. I am now spending my time
with different but still challenging new projects outside of the medical field.