Cardiac Control Systems, Inc. page 2
After spending a month in the British Isles we flew back to Florida. I recall talking to Simon at 30,000 feet above the Atlantic saying, “You’re carrying a briefcase worth 5.75 million dollars, add that to the 1.5 million that we raised before and we are now worth something in the neighborhood of 7.25 million dollars. Our responsibility to the shareholders is awesome. We come to the investors with a slideshow presentation; they listen to it and give us money in return for a stock certificate. They do it because they have faith in us and they expect a profit on their investment. Simon, we have to do everything in our power to make cardiac control systems a first-rate company.” The dedication and responsibility that the Board of Directors has to the investors is a heavy weight to carry. There is a tendency to become giddy when you realize that you’re raising millions of dollars with nothing but an idea and a promise. That feeling evaporates quickly under the burden of responsibility.
Once we had the money, the next two items on the agenda were to get the building finished and to start work on the custom designed microchip that would run the pacemaker. I was made Chief Executive Officer with Simon Fuger, Executive Vice President. Simon and I took charge of construction and Bob Brownlee, Executive Vice President, Engineering, took over the microchip development. Bob brought a team of players from State College, Pennsylvania, among them, Paul Neff, engineer, Clair Harper, master machinist, Beri Shimmel, technical writer and Jim Skelly, computer guru. Bob Brownlee spent the next 12 months at Harris Semiconductor Company in Florida. Chip design was a major problem in our timeline and kept expanding from month-to-month. Every time we thought the chip was ready, it had to go back for another iteration, which meant another month delay at work in process.
In contrast, the construction of the building went rather smoothly. We dug out the floor, added 5 feet to the height of the building and added a second story. In a small way, we were victimized by the progress of technology. At the time, all companies manufacturing cardiac pacemakers did so in a “clean” room. We designed a “clean” room" for our facility. “Clean” rooms are an extraordinarily expensive proposition. About three months after we had the building open and running, word hit the industry that “clean” rooms were no longer necessary for the manufacture of cardiac pacemakers. We ate the bullet on that expenditure but we did have a functioning “clean” room.
Keep in mind that we were almost 2 years with no income. Our balance sheet was naked on the income side and all we did was subtract from capital. Meanwhile, we tried to entice physicians, salesmen and pacemaker personnel to join us in Palm Coast. We had to be careful about hiring because each salary subtracted from capital. During the startup time we put out several more private placements after the one large one in the UK. It appeared that we were good at raising money but not too good at getting a functioning chip out of Harris Semiconductor. The long-awaited day finally came and we began a “work in process” line to complete pacemakers and have them ready for implantation.
Keep in mind that we were almost 2 years with no income. Our balance sheet was naked on the income side and all we did was subtract from capital. Meanwhile, we tried to entice physicians, salesmen and pacemaker personnel to join us in Palm Coast. We had to be careful about hiring because each salary subtracted from capital. During the startup time we put out several more private placements after the one large one in the UK. It appeared that we were good at raising money but not too good at getting a functioning chip out of Harris Semiconductor. The long-awaited day finally came and we began a “work in process” line to complete pacemakers and have them ready for implantation.
In the interim, personnel had to be hired to perform many of the tasks ancillary to completing the pacemaker. That meant writing protocol for quality assurance as well as a complete document for each step in the assembly of the pacemaker. We were under the constant scrutiny of the FDA. The process of going from design to finished product was far different from the days of Intermedics. Protocols had to be developed for packaging the product and physician’s manuals had to be written. These documents would be scrutinized by the FDA and we would be held accountable for each step along the way. During that time we recognized that at the end of the day, we had to sell the product.
Engineering the Pacemaker
In The Clean Room
CCS Maestro 101 With Leads
Developing a sales force proved to be the most difficult project of all. We did not have the time or the money to recruit, hire and train salesman, so we had to resort to the medical representative route. How do you get salesmen who are very comfortable selling products for competition to leave and join your effort? The answer is you have to steal them. You have to make things sound so good that they’re willing to give up what they have for a promise of what more they can get in the future. We had to offer a better contract than they had at present which meant a larger territory, a longer contract term, and most of all, a better commission. The negotiations between the company and the salesman got to be ridiculous. There was a time when they were asking for monthly guarantees as well as 35% and 40% commission on the sale of the product. One salesman had the colossal effrontery to ask for a $1 million escrow for the first year. The sales reps were making an inordinate amount of money, but not that much. It was frequently the case that an Intermedics sales rep was making more money than the doctors he was servicing. It was an impossible task but we had to start somewhere. We figured that if we could lure one or two good men on board, others would follow. It was an expensive proposition but somehow we got started.
The first pacemakers began to roll off the line and were put into the testing tanks. We decided to name the product “The Maestro”. It was a good name in that we were conducting cardiac rhythms and we felt that our pacemaker was the best product on the market. It certainly had many innovations that the competition lacked. After a month’s worth of testing we felt secure that we could attempt a human implant. It was done successfully and the patient went home in good condition, the pacemaker functioning flawlessly. Overtime, the Maestro series continued to develop. Bob Brownlee and his engineering team deserve a lot of credit. There were months of frustration and endless delays in getting a chip that met specifications. As I write this it seems like an easy step from the drawing board to the end product but the truth is it was long, difficult and at times, agonizing. There is so much to do between the idea and the final product that it is a wonder that we made the attempt. One of the attributes of human nature is the indomitable spirit that drives men towards a goal.
The next year was spent in refining the product and adding more technological improvements. We were moving along but so was the industry. It was maturing. The medical application of cardiac pacing had changed dramatically since the early days of Intermedics. Back then, the product was viewed with a certain degree of awe and a bit of mystery. There were only a few dozen physicians who understood the technology, were dedicated to cardiac pacing, and were familiar with the product. As the product advanced in technology from a simple fixed rate pacer to the much more improved sense - inhibited models, the indications for cardiac pacing increased exponentially. With more indications to do the procedure, more physicians began to do implants. Very early on, the first pacemakers were done by securing electrodes to the surface of a heart and then putting the pulse generator somewhere in the abdomen. With the advent of transvenous electrodes, the procedure became much less tedious. With the passage of time, the allure of doing pacemakers began to wear off and physicians tended to look at the procedure as simple and commonplace.
Not so the technology; new innovations were the meat and potatoes of the engineering world. For a while, it seemed like every month there was a new wrinkle to pacing technology. By the time we got into the marketplace, cardiac pacing had matured and the days of salesmen shooting from the hip and bringing new products into the operating room with no more than a comment or a flourish were over. It’s sad to admit but, from my point of view, doctors were not interested in learning about the technology; all they wanted was a product that was easy to implant and would do the job. We at Cardiac Control Systems had our heads buried in advancing technology.
We produced a continuing line of pacers that far out did the competition in technologic improvements, telemetry, size and weight. The electronics kept getting smaller and the only thing that impaired the foot print of the pacer was the power source. We manufactured a series of Maestro pacers that were the best in the marketplace but we did not have the sales muscle to get them sold in high enough numbers. We wrote a new language for dual chamber pacing and published it in several prestigious medical journals. The code enabled the physician to dial in any combination of sense-pace in either or both chambers. We built a programmer that would make it east for the physiciam. I thought the new code was the answer to the problems of dual chamber pacing, but the medical world gave it a ‘ho-hum’ and there it sat. There is a bit of jealousy in the professional world along with the fierce attacks from the competition.
Not so the technology; new innovations were the meat and potatoes of the engineering world. For a while, it seemed like every month there was a new wrinkle to pacing technology. By the time we got into the marketplace, cardiac pacing had matured and the days of salesmen shooting from the hip and bringing new products into the operating room with no more than a comment or a flourish were over. It’s sad to admit but, from my point of view, doctors were not interested in learning about the technology; all they wanted was a product that was easy to implant and would do the job. We at Cardiac Control Systems had our heads buried in advancing technology.
We produced a continuing line of pacers that far out did the competition in technologic improvements, telemetry, size and weight. The electronics kept getting smaller and the only thing that impaired the foot print of the pacer was the power source. We manufactured a series of Maestro pacers that were the best in the marketplace but we did not have the sales muscle to get them sold in high enough numbers. We wrote a new language for dual chamber pacing and published it in several prestigious medical journals. The code enabled the physician to dial in any combination of sense-pace in either or both chambers. We built a programmer that would make it east for the physiciam. I thought the new code was the answer to the problems of dual chamber pacing, but the medical world gave it a ‘ho-hum’ and there it sat. There is a bit of jealousy in the professional world along with the fierce attacks from the competition.
One of the giant steps that we took was to develop a lead that would sense and pace in both chambers. Bob Brownlee and his team were indefatigable and worked on the product until it was perfect. Then we had to develop a pacemaker that would function in both chambers coupled with the lead. It was named the “Maestro SAVVI” because it was a smart and very savvy pacemaker that would sense and pace in both chambers using a single lead in the right ventricle. Concomitant with the pacemaker was the development of an entirely new language and a programmer that would allow the physician to pick and choose any combination of sense - pace in either or both chambers. You would think that a product like that would burn a hole in the marketplace, but such was not the case.
CCS SAVVI Multifunctual Dual Chamber Pacemaker
With Single Lead
With Single Lead
CCS All Purpose Programmer
I will admit that it was not an easy product to use without learning the new language code and some deep understanding of the underlying technology; and therein was the rub. Doctors did not want to take the time to learn the esoterics of the product. They did not want to learn a new language; the old three letter code was enough for them. They were accustomed to going into the operating room, doing the procedure in 30 to 45 minutes and not be concerned about the settings on the programmer. Most physicians were content to sense and pace in one chamber. The few who were eager to use the Maestro SAVVI were not enough to make a dent in the market. Coupled to that was the fact that the sales reps were not keen to spend time explaining the nuances of the product because, frankly, they didn’t understand it either, and were not about to waste time learning it when they could bring in a product that was easier to sell.
The new language for pacemaker settings never became popular. The three letter code that was in use for years was modified and accepted by the medical world. Our new language and code system withered and died. Single lead dual chambered pacing was accepted throughout the medical world but by that time we had lost momentum in the marketplace.
The company battled along but never gained a perch in the hierarchy of the pacemaker industry. It was a fourteen year struggle but we were never profitable enough to bring a return to the investors. That was the hardest thing for me to accept. In time, the company was bought and most of the old-timers dispersed. The sad thing about it is that it was not from lack of effort or dedication. Looking backward, there were probably a multitude of reasons but the result was a Solemn Requiem.
Somewhere out there is a huge corporate graveyard wherein lie the proud and tattered remnants of companies that fail to make it to the top. Cardiac Control Systems, alas, lies among them.
The new language for pacemaker settings never became popular. The three letter code that was in use for years was modified and accepted by the medical world. Our new language and code system withered and died. Single lead dual chambered pacing was accepted throughout the medical world but by that time we had lost momentum in the marketplace.
The company battled along but never gained a perch in the hierarchy of the pacemaker industry. It was a fourteen year struggle but we were never profitable enough to bring a return to the investors. That was the hardest thing for me to accept. In time, the company was bought and most of the old-timers dispersed. The sad thing about it is that it was not from lack of effort or dedication. Looking backward, there were probably a multitude of reasons but the result was a Solemn Requiem.
Somewhere out there is a huge corporate graveyard wherein lie the proud and tattered remnants of companies that fail to make it to the top. Cardiac Control Systems, alas, lies among them.
CCS Telemetry Recorder