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Refractive Surgery | Jun 2011

Industry Interview: Tradition of Swiss Precision Continues

Ziemer Group AG (Port, Switzerland) first attracted attention in the ophthalmic world when it introduced the Amadeus microkeratome under the name Surgical Instrument Systems (SIS). That device, manufactured by SIS and distributed by Allergan Inc. (Irvine, California), drew attention because of its innovative automated design. With a reputation for Swiss precision technology, it was only a matter of time before Ziemer entered the ophthalmic market on its own, and the company soon became known for high-quality surgical and diagnostic products. The Pascal Tonometer brought better precision and new types of information to glaucoma specialists, and the Galilei Dual Scheimpflug Analyzer; Maxwell aberrometer; and femtosecond laser, the Femto LDV, were welcome additions to refractive surgical practices.

In the interview below, Frank Ziemer, President and Chief Executive Officer of Ziemer Group AG, talks about the philosophy of his company and its role in the ophthalmic marketplace. Christian Rathjen, Vice President of Technology and Strategy for Ziemer, also shares his insights.

CRST Europe: Please tell us about how Ziemer began.

Frank Ziemer: I founded the company in 1998 with the idea of developing, manufacturing, and marketing high-technology products for ophthalmology. At that time, my family had already been involved in ophthalmology for a couple of decades. I started my career at Meyco, the Swiss diamond knife company, and learned the business there. I was a member of the corporate management when I left.

I began my career during the era of radial keratotomy (RK), and I had the opportunity to visit and observe Svyatoslav N. Fyodorov, MD, in Russia, and other refractive surgery pioneers. Meyco developed many products for the refractive surgery market before the advent of excimer lasers. We manufactured most of the diamond knives used in RK; many of the diamond knives sold by Katena (Denville, New Jersey), Storz (Bausch + Lomb, Rochester, New York), and other companies were ours. So I had an interest in corneal and refractive surgery from the beginning.

Meyco was specializing in precision instruments, but I had a different idea for Ziemer. When the excimer laser appeared, I felt that the ophthalmic market, specifically the refractive surgical market, was about to change dramatically.

With the interest in LASIK growing, there was a high demand for microkeratomes. We analyzed the microkeratome market and saw that, if we offered a better technology than what was currently available, we had a chance to enter the market in a strong position. That led to our development of the Amadeus microkeratome. We were wise at the beginning to partner with Allergan Inc. for distribution of the Amadeus. This was before Advanced Medical Optics (AMO; now Abbott Medical Optics Inc., Santa Ana, California) was split off from Allergan in 2002. After the split, AMO took over distribution of the Amadeus.

The Amadeus was the first microkeratome with an electronically controlled handpiece that was fully automated and operated via a color touchscreen. Perhaps a touchscreen sounds elementary nowadays, more than 10 years down the road, but it was quite an innovation when that device entered the market. And of course Swiss precision was important in that first product, as it has been in all our subsequent products. Five years after AMO’s separation from Allergan, AMO completed the acquisition of IntraLase and its femtosecond laser technology. The company decided to focus its attention on this new technology, and as a result we had to cancel our contract for distribution of the Amadeus.

As you can imagine, this brought about changes and challenges for us, but in hindsight I can say it was for the best. It forced us to grow; to put our company on its own footing in regard to marketing and sales; and to build our own distribution channels, which now reach nearly 50 countries around the world. By this point we were also working on femtosecond laser technology. We foresaw that we would become competitors with our former partner, AMO, because we planned to launch our own femtosecond laser.

CRST Europe: Do you have advantages marketing your products in Europe as a locally based Swiss company?

Ziemer:We have advantages here in Europe, although we have good relationships in other parts of the world. We are close to the European markets, and for products such as ours service is extremely important. With our centralized location, if there is a service issue in France, in Italy, or in Germany, for instance, we can be there within hours. And because people in our company speak those languages, we can communicate with our customers in their own language. These are two important factors in the success of our company.

Regarding the Swiss reputation for precision manufacturing, we are located in the region traditionally associated with the Swiss watchmaking industry. As you can imagine, there is also an extensive peripheral industry devoted to delivering whatever technologies the watchmakers need, such as assembly lines, tools, and electronics. About 30 years ago, many of the companies that provided these products and services for the watchmaking industry started doing the same for the pharmaceutical and medical device industry. Companies that were already good at making injection-molded plastic components for Swatch realized that they had the capability to develop similar components for the pharmaceutical and medical companies that are also based here, such as Roche and Novartis, both in Basel. As a consequence, this area has become the Silicon Valley of microtechnology for Europe. Within 2 hours by car, you can find everything you need in research and development, prototyping, and manufacturing to build highly complex machines such as femtosecond lasers. To do that in the United States, you would be running from one coast to the other.

The manufacturing tradition and culture here are huge advantages. The fathers and grandfathers of our employees were involved in this high-tech business. And in our dualeducation system, many young people do not go directly to college from secondary school, they first do an apprenticeship in mechanics or electronics for 3 or 4 years. After that, they can go on to university or engineering school. People with those apprenticeship backgrounds in manufacturing are world-class. They help us tremendously to create our high-end products in Switzerland. I firmly believe there is no better place than our region to produce the types of ophthalmic technologies Ziemer has in its portfolio.

CRST Europe:With the Femto LDV, Ziemer is one of a number of companies offering femtosecond laser technology. Where do you see this technology going, and how would you differentiate your technology from others’?

Ziemer: Many people think a femtosecond laser is a femtosecond laser. This is of course not the case. We drive our Femto LDV laser in a manner completely differently from our competitors. This is the main factor in why it is successful.

Christian Rathjen: Our laser system has a few big differences from the other systems on the market. First, it is mobile (handheld), and you can operate under any excimer laser system. It also does not need additional air conditioning. These things are true, but there is something more, something related to laser physics and how the device cuts.

In simple terms, the key factor for our better clinical results is that we use 10 to 100 times lower energy per pulse at a high repetition rate—in the megahertz range. This virtually eliminates side effects such as transient light sensitivity, opaque bubble layer, and diffuse lamellar keratitis.

This is proprietary technology, but even so it would be difficult for our competitors to copy because it is related to the design of our handpiece. We can focus the laser more strongly than anyone else, and therefore we can use lower pulse energy.

We have demonstrated that this technology allows us to cut flaps that you cannot see. The laser dissects the cornea, and you can open it without tissue bridges. There is basically no intrastromal gas production when cutting in this mode. None of our competitors can do that.

Ziemer: The pulse energy of our laser is orders of magnitude lower than those of all other companies in this field. This leads to crystal-clear corneas immediately after surgery, which means the patient can see well immediately.

We have several clients who worked for 6 or 7 years with another device, and when they started to use our machine they noticed the difference: better visual outcome, faster recovery, and happier patients. This is why, for instance, the largest refractive surgery clinic in the world, the Shinagawa Clinic in Tokyo, has chosen to use our systems for more than 90% of its surgeries in a highvolume setting (10,000 to 12,000 cases per month). Memira, one of the largest laser center chains in Europe, has decided to use our systems, as has the English chain Optegra. The surgeons really notice that there is a difference in precision with the Femto LDV.

Rathjen: We often give clients an evaluation phase during which they can test the Femto LDV for 2 or 4 weeks. Our femtosecond laser has the flexibility to be used with any excimer laser on the market. This is one of the things we had in mind when we were designing the system, not only to be focused on compatibility with existing excimer laser systems but also to anticipate potential future systems.

CRST Europe: What do you see as Ziemer’s role in the ophthalmic marketplace?

Ziemer: We want to be the clear leader in femtosecond laser technology and related diagnostic devices. We see ourselves as using a classic strategy of high-tech differentiation and quality. We are not cheap; we are a Swiss company, with all the tradition of precision that entails. Labor and research and development (R&D) are rather expensive here in Switzerland, but they are of world-class quality.

We want to employ the best people from Switzerland and also from Germany, where our exclusive partner for laser physics, the Laser Zentrum Hannover, is located. Holger Lubatschowski, PhD, and his team in the biomedical optics department work closely with our staff on the technical, R&D, and scientific aspects of laser physics.

Of course we do not have the size of some multinational companies. However, if you compare the number of people working in our company in R&D and manufacturing for these technologies, diagnostic instruments and femtosecond laser technology, our teams are the same size as those of the multinational companies. We are familiar with the structures at several larger companies, and I may say we have no disadvantages in R&D and manufacturing personnel, and perhaps we have some advantages.

CRST Europe: Do you reach the entire European marketplace? What is your position beyond Europe?

Ziemer: We are active in the Western European market and in Scandinavia. We are probably the only company with a lot of placements in the Nordic countries of Finland, Norway, and Denmark. We are also active in the emerging Eastern European markets. They are developing rapidly, and those surgeons are interested in good technology. We have a number of markets in Asia. South Korea has been a good market for us for a couple of years. We are now extremely active in China and Taiwan, working with Clinico, the largest ophthalmology distributor in both Taiwan and China. This year, we will probably have more machines installed in China and Taiwan than any other company.

We have a subsidiary in the United States, Ziemer USA (Alton, Illinois). Because of the size of the country, it is difficult to work with a small or mid-size distributor. Either we had to partner with a multinational company or start our own subsidiary, so the latter is what we did a couple of years ago. We are also active in the important Latin American countries including Mexico, Chile, Brazil, and Argentina. And we have a start in the Arabic countries. We are active in many countries, but of course there are still many other countries where the market is not ready for our technology.

CRST Europe: Ziemer markets both surgical and diagnostic equipment. Why is this important?

Ziemer: We decided several years ago that if we wanted our technologies to perform highly precise procedures on the cornea or the lens, we had to have good metrology— good diagnostic devices. We had to know what is going on in the cornea, on the cornea, and in the lens. That was why we decided to invest heavily in developing diagnostic devices such as the Pascal tonometer, the Maxwell aberrometer, and the Galilei Dual Scheimpflug Analyzer. This was not an easy decision, but it has helped us tremendously to understand all the aspects of the tissues we are operating on from a diagnostic point of view and to bring that information to the development of the laser. We feel that the two go hand in hand.

CRST Europe: Will you be adapting your femtosecond laser for cataract capabilities?

Ziemer: It is a must for a company like ours. We cannot at present give a timeline for the introduction of this technology, but Christian can talk about the technology.

Rathjen: In terms of technology, cataract applications are not as demanding as anything you have to do on the cornea. The technology other companies are using for femtosecond cataract surgery now is technology that we were using in the laboratory 6 or 7 years ago when we started the development of our devices. We are actually more concerned with the marketing. Everyone wants to have a device for laser cataract surgery, but no one wants to spend $500,000 for it.

Ziemer: We can say in good conscience that we have the technology now. And we have the advantage that we have built our femtosecond laser in a modular platform, so we can add the cataract functionality to our portfolio. We are experts in optics, so we know what optics are required to use a femtosecond laser at 200 μm or 500 μm depth in the cornea, or deeper in the lens. We have the necessary imaging technology, and we are working with an external group on scanning technology.

As Christian said, the key factor for success is the right business model. Will this technology be a premium market segment? Can we convince the insurance companies in Europe to reimburse for it? Will surgeons be able to bill the patient for use of the higher technology? (Currently in Europe they cannot.) Will surgeons in high-volume markets such as India and China invest in a $500,000 device for laser cataract surgery? Will surgeons be willing to pay a perprocedure fee for disposables such as those that have been announced by other companies? These are key factors for success that we must consider while we are fine-tuning our machine to the needs of the market.

CRST Europe: What do you see for the future of your company and for the ophthalmic market?

Ziemer: We recently had a meeting with our distributors, and they were asking questions: What is coming next, what is the future of femtosecond technology, what will we be doing in 5 years? I said that when we come together here in Berne 20 years from now, it is my firm belief that we will still be speaking about femtosecond laser technology for ophthalmology. It is a new paradigm in ophthalmology. There will be many cycles, as there have been with phacoemulsification technology, and it will continue to be important in the upcoming years.

Rathjen: People like to compare femtosecond lasers to excimer lasers. But excimer lasers can be used only on the surface of tissue, and the only acceptable surface is the cornea. With femtosecond lasers, on the other hand, basically the whole eye is accessible. This is a fundamental difference. There is more that can be done than working only on the cornea or in the lens. There has always been the dream of a surgical laser knife. The laser knives used on a daily basis in machining and manufacturing cannot be used in surgery because of their side effects. But with femtosecond lasers we can reduce the side effects to the extent that they are comparable to or less than the side effects of cutting with a good diamond blade. We are, for the first time, now in a position to develop a laser blade for surgical applications. In terms of applications and possibilities, this is a quantum leap.

Ziemer: I started in ophthalmology working with Meyco’s precision diamond knives in ophthalmic surgery. It is gratifying now to be working with a technology that will enable us to bring the even greater precision of the femtosecond laser to the world of ophthalmology.

Frank Ziemer is the President and CEO of Ziemer Group. He may be reached at e-mail: Frank.Ziemer@ziemergroup.com.

Christian Rathjen is Vice President of Technology and Strategy of Ziemer Group. He may be reached at e-mail: Christian.Rathjen@ziemergroup.com.