PRIVATE CLIENT STUDIES – Arthur D. Little (1972 - 1994) and Spectrum Consulting (1994 - 2001)

In addition to the hundreds of articles and columns written over my 30-plus years of consulting, I led over 100 client-sponsored studies, covering a variety of topics. Here are the titles of most of the reports I either wrote or led the effort in producing. Some of the titles have been partly redacted to prevent identification of the client.

Note that nearly all of the studies until 1985 involved contact lenses, at which time I began consulting in medical lasers.

(Bolded studies can be found online.)

1972
● Worldwide Review of Soft Contact Lenses Made of Hydron (B&L Soflens), August 1972

1974
● Technological Developments in Ophthalmic Lens Materials and Processes, February 1974

1976
● The Contact Lens Business--An Emerging Opportunity, June 1976
● Investigation of the Coating Buildup Problem on Soft Contact Lenses, November 1976
● The Soft Contact Lens Business--Profile of an Opportunity, December 1976

1978
● Technical Assessment of a Soft Contact Lens Automated Machining Center, April 1978

1979
● The Contact Lens Solutions Business: An Opportunity for -- --, January 1979
● An Evaluation of Wesley-Jessen's Contact Lens Technology, August 1979
● Identification of a Soft Contact Lens Licensing Partner for -- --, November 1979
● Current and Future Developments in the Contact Lens Industry, December 1979
● An Evaluation of Titmus Eurocon's Contact Lens Technology, December 1979

1980
● A Technology Forecast: Vision Devices 1980-2000, January 1980
● The Development of an Improved Eyeglass Frame Material and Manufacturing Process, March 1980

1981
● Projections of the Markets for Hard Gas Permeable Contact Lenses, January 1981
● The Technical Evaluation of Frontier Contact Lenses Inc., January 1981
● An Overview of the U.S. Contact Lens Business, January 1981
● The Development of Novel Low Cost Disinfection Systems for Soft Contact Lenses, February 1981
● A Worldwide Review of Hard Gas Permeable Contact Lenses, February 1981
● Technical Evaluation of a New Contact Lens Manufacturing Process, February 1981
● An Analysis of the Contact Lens Business of -- --, March 1981
● A Worldwide Overview of the Ophthalmic Industry for the Scottish Development Authority, June 1981
● A Comparison of Low, Medium, and High Water Content Contact Lens Systems, July 1981

1982
● Technical Evaluation of an IOL Research and Manufacturing Operation, January 1982
● The Offering of a Contact Lens Company to Prospective Buyers, Winter 1982
● The Offering of a Retail Optical Business (Inventory, Lab Equipment and Fully-Equipped Dispensing Offices) to Prospective Buyers, Spring 1982
● The Development of a Low Cost Chemical Disinfection System for Soft Contact Lenses, February 1982
● An Overview of Diagnostic and Surgical Ophthalmic Equipment, July 1982
● Current Developments in Hard Gas Permeable Contact Lenses, December 1982

1983
● Assessment of a New Contact Lens Manufacturing Technology, January 1983
● Evaluation of a Soft Lens Cleaning Device, February 1983
● Technological Developments in the U.S. Contact Lens Industry, April 1983
● Near Term Trends in the U.S. Contact Lens Industry, June 1983
● Technological Assessment of -- --, October 1983
● Packaging of a Peroxide Neutralization System, November 1983
● Analysis of R&D and Regulatory Capabilities of Major U.S. Contact Lens Companies, December 1983

1984
● Background Papers on Soft Contact Lenses and Care Products, January 1984
● A Background Report on the Contact Lens Industry in the U.S., January 1984
● The Establishment of a Transfer Price for Contact Lens Blanks, January 1984
● Development of a Tensile Testing Method for Contact Lens Materials, January 1984
● An Overview of Trends and Developments in Eyeglasses and Contact Lenses, March 1984
● The Offering of a Contact Lens Laboratory and Fitting Clinic, April 1984
● The Establishment of a Transfer Price for Intraocular Lenses, April 1984
● The Outlook for the Ophthalmic Products Industry, May 1984
● An Assessment of Competitive Soft Lens Tinting Technologies, June 1984
● Current Trends in the U.S. Contact Lens Industry, September 1984
● Survey of Practitioner Attitudes Toward Cosmetic Extended Wear, November 1984

1985
● Comparison of Estimated Soft Lens Manufacturing Costs, February 1985
● An Update of Near Term Trends in the U.S. Contact Lens Industry, May 1985
● Contact Lens Manufacturing Techniques, August 1985
● The Offering of a New Soft Bifocal Contact Lens for Licensing, September 1985
● Entry Strategy to the U.S. Contact Lens Market, October 1985
● Update of the U.S. Ophthalmic Industry, November 1985
● Technology Assessment of the Green YAG Laser, November 1985

1986
● The Outlook for Refractive Surgery: The Impact of the LRK Technique, March 1986
● The Valuation of an IOL and a Surgical Instrument Companies, June 1986
● The Valuation of an Ophthalmic Products Company, November 1986
● A Brief Study of the CL Market in Japan, November 1986
● The Valuation of an Ophthalmic Instrument Company, December 1986

1987
● Ophthalmology Technical Alert Service, 1987
● An Overview of the Presbyopic Market Place: The Prospects for a New Viable Bifocal Contact Lens Design, February 1987
● A Detailed Survey of the CL Market in Japan, February 1987
● The Outlook for Viscoelastic Substances in Ophthalmology, May 1987
● An International Overview of Contact Lenses, June 1987
● The Nature and Evolution of the Soft Contact Lens Industry in the United States, August 1987 (B&L vs. the IRS)

1988
● The Current and Theoretical Production Capacity of the U.S. Contact Lens Industry, April 1988
● Evaluation of CooperVision, June 1988
● Medical Laser Overview, August, 1988
● Technical and Market Analysis of -- --, July 1988
● Ophthalmic Market Overview, September 1988
● Technology Overview: Ultrasound Catheter Market, December 1988

1989
● Ophthalmic Surgical Equipment Overview, March 1989
● U.S. Market for Soft Contact Lens Lubricant/Rewetting Drops, March 1989
● Contact Lens and Care Product Market Overview, May 1989
● Update: The Outlook for Laser Refractive Surgery, August 1989

1990
● Development of a Manufacturing Plan for Medical Lasers: Product Selection, January 1990
● Technology Overview: Phoenix Laser Systems, March 1990
● Current Developments in Laser Refractive Surgery, July 1990
● Opportunities for Collaboration, September, 1990
● An Evaluation of a New Eyeglass Lens Molding Process, Phase I: Technology Overview, September 1990
● Overview of High-Index Plastic Eyeglass Lens Materials, November 1990
● Background Information on the Contact Lens Industry, December, 1990
● Profitability in the Ophthalmic Industry, December, 1990

1991
● Contact Lens and Care Product Overview, January, 1991
● Current Developments in Laser Refractive Surgery, March 1991
● An Overview of the U.S. IOL Industry, April 1991
● Ophthalmic Industry Overview, August 1991
● Overview of Current Developments in Refractive Surgery, August 1991
● Technology Overview: Phoenix Laser Systems, October 1991
● Overview of the IOL Industry, September 1991

1992
● Excimer Lasers in Surgery, February 1992
● Current Developments in Laser Refractive Surgery, March 1992, updated July 1992
● New Ophthalmic Laser Technologies, June 1992
● Historical Overview of Ophthalmic Lasers in the Mid-1980s (legal case), July 1992
● Medical Laser Technology Alert Reports, monthly, July 1992 - April 1993

1993
● Technology Overview and Strategic Partnering for Unique Medical Laser Product Company, September 1993
● The Outlook for Refractive Surgery Centers, September 1993
● A Cost Comparison of Refractive Surgery vs. Eyeglasses and Contact Lenses, October 1993
● An Overview of Current Developments in Refractive Surgery, December 1993

1994
● An Assessment of a Laser-based Method to Alleviate Heart Attacks, February 1994
● The Outlook for a Laser-based Technique to Cure Psoriasis, March 1994
● Current Developments in Laser Refractive Surgery, August 1994, updated April 1995
● An Assessment of an Unique Laser-based Technique to Diagnose Severe Burns, August 1994

1995
● Estimated Market for a New Mid-IR Laser Delivery Fiber, February 1995
● The Outlook for Refractive Surgery, March 1995
● An Analysis of the Hawaii PRK Market, May 1995

1996
● Potential Laser (and non-laser) Sources for Activating Photofrin, March 1996
● Search for a Diode Laser Source for Activating Photofrin, April 1996
● A White Paper -- Laser Hair Removal: An Application Whose Time has Come, October 1996
● Worldwide Market Overview of Ophthalmic and Dermatologic Lasers, December 1996

1997
● U.S. Market Opportunities for ICON Centers for Cosmetic Surgery, March 1997
● Refractive & Cosmetic Surgery -- Any Synergies?, November 1997
● An Overview of the Medical Laser Industry, December 1997

1998
● Worldwide Medical Laser Marketplace, May 1998
● An Investigation into the Use of "Bermuda Cards", July 1998
● Review of Photodynamic Therapy for Treating ARMD, December 1998

1999
● Update: Trends in Refractive and Cosmetic Laser Surgery, November 1999
● An Evaluation of ThermoLase's Technologies, December 1999

2000
● A Look at the Future of Refractive Surgery, February 2000

2001
● A Brief Overview of the Opportunities for a 3 micron Medical Laser System, July 2001
● Adoption Rates of Soft Contact Lenses, IOLs, and Refractive Surgery, September 2001

Cast-Molded Eye Glass Lenses

I recently heard from a couple of old friends back from my contact lens days. They are starting a new company to produce ophthalmic lenses in an eye care professional’s office. I had done some consulting work on in-office plastic lens molding in the early 1990s and had also studied the high-index plastic lens business. I wrote about one of the innovative in-office lens molding companies in an OSN Technical Update column in 1993, and my friend was wondering if I still had a copy of the column.

I managed to find the column I had written on my old computer, and since my friends were developing a new company based on this type of process, I decided to reproduce the original column as it relates the history of in-office lens casting.

As a salute to my old friends Tim Rogers and Steve Martin, and their new company QSpex Technologies and its Lens Transformation Process, here is what I wrote about Innotech and its Excaliber lens molding system back in the March 15, 1993 issue of Ocular Surgery News.


TECHNOLOGY UPDATE

The Excalibur SurfaceCasting System from Innotech: "He who has the sword shall be King!"

Irving J. Arons
Ophthalmic Consulting Group
Arthur D. Little

Over the years, several groups of innovative people have attempted to bring techniques for making "instant" ophthalmic lenses in the office or dispensary to market. These attempts reached their peak about five years ago with the advent of LensCrafters' advertisements for "1 Hour Service".

Since the LensCrafter claims to make most Rxs in about an hour were based on having an in-store processing lab, to stay competitive both independent dispensers and other chain retailers explored the options for making "fast" lenses offered by the likes of Vision Sciences and Technavision, the then (barely) surviving in-the-office lens casters.

Technavision, originally known as Orplex, was born in 1982, while Vision Sciences came along a few years later. And then there is Henry Earle, the grandpappy of lens casting, with his Duralens process, which was started in the early 1950s. Later on in 1988 Larry Joel developed his "Fast Cast" system, which he sold to Pearle Vision allegedly for $25 million. Pearle is still working to get the bugs out of the system before releasing it to its retail outlets.

Along the way, both Henry Earle (in about 1985) and Norman Rips, perhaps a year or so later, each developed wafer bonding methods -- the gluing of a thin lens carrying the Rx and/or bifocal correction onto a base stock lens. The Rips' system, originally called the Krom-X process, is now known as the Dicon Instalens process and is still being sold, now by Dicon/Visimed (San Diego). And other wafer systems are being developed by such as Tandem Optics (Rochester, NY), Pentax (Japan) and Sola Optical (Petaluma, CA).

Now, a new company, Innotech (Roanoke, VA), founded by Ron Blum and a group of people formerly associated with Vision Sciences, have come up with a hybrid technology, half way between the old thermal cast molding technique and the newer UV adhesive wafer technology. It is called SurfaceCasting using the Excalibur Office-Based Lens Fabrication System.

This patented process involves a single glass mold -- with either a progressive or flat-top 28 design, a proprietary, thin CR-39-based backup wafer (single vision lens) or Power Plate as the company calls it, a specially formulated CR-39 liquid monomer containing UV curing initiators, and a UV curing apparatus.

In use, two flat-top or progressive molds are placed into a holding tray, about a teaspoonful of the monomer is added to each mold, and the appropriate power plates positioned on top. No gaskets or pressure holding devices are used. The sandwiches are placed into a small UV curing chamber polymerizing the resin which bonds to the power plate backup wafer (back surface of the lens), and assumes the shape (and power) of the mold surface (front lens surface). This resin polymerization process takes about 27 minutes. The cured sandwiches are then placed into a demolding apparatus which separates the finished lenses from the molds in about two minutes. The whole process to produce a pair of bifocal or progressive lenses, including selection of the appropriate molds and wafers, assembly, curing, and demolding, takes about 35 minutes.

According to industry experts from LensCrafters and Texas State Optical who have observed the process close up, operating the system at three beta sites each, the system produced first quality, thin lenses (that the company claims exceed ANSI lens standards) at affordable prices. Innotech claims that the new UV processed lens is about 20% harder than conventional CR-39 lenses and therefore may not require a scratch-resistant coating. Innotech further claims that lenses made using the technique can save a dispenser an average of about 65% of the cost of buying progressive lenses from a lab, and about 35-40% of the cost of typical flat tops. (In the company's calculations, this worked out to about $15 per pair versus $45 for unfinished 75mm progressives and $12 versus $18 for the 75mm flat tops.) Further, the finished lenses can be hard coated, tinted, and anti-reflection coated similarly to standard CR-39 lenses.

For now, a series of 108 core molds can be obtained to make either flat-top 28s (54 molds) or their proprietary progressive design lenses (another 54 molds), with spherical powers from -4.00D to +4.00D, cylinder powers of -0.25 to -2.00D, and add powers of +1.00 to +3.00D. The progressive lens design is a "semi-soft" style according to company executives.

As noted, the system has been beta tested for a minimum of three months at seven sites, including three LensCrafters and three Texas State Optical retail locations. It will sell for approximately $32,000, plus an additional $3000 for an initial supply of monomer and a customized inventory of power plates depending on the practice size and lens type usage. The price includes two days training, service and a one-year warranty. The company claims the system is capable of producing up to 12 pairs of multifocal lenses per day, and that a typical dispenser using the Excalibur SurfaceCast System to produce 6-8 pairs of multifocals per day would pay for it in less than 2 years.

The Excalibur is self-contained with a microprocessor control unit, built in resin dispenser (and reservoir), curing chamber, and mold and wafer inventory holding drawers.

For those interested in seeing the system up close and personal, it will have its first public demonstration at Vision Expo in New York city at the end of March.


A number of question remain to be answered:

● Will high-index resin material and back up wafers be available any time soon to produce high-index lenses?

● The company claims to be able to produce "thin" lenses. How thin is thin?

● What is the life time of the molds? For how many cycles can they be used? What is the cost of replacement molds?

● What is the real cost per lens pair when labor, mold replacement, cleanup and other miscellaneous costs are included?

● What is the yield of high quality lenses? How much breakage/spoilage can be expected over a years usage?

● What skills are required to run the system? Can a lab tech run it, or is special training/education required?

● Will proprietary progressive lens designs such as Varilux be made available in the future?


The company's R&D plans are to extend the SurfaceCasting technology to include production of IOLs, bifocal and toric contact lenses, and consumer and aerospace optics in the future.

Although our initial impression of the system is that it appears promising, perhaps even "revolutionary", as with all things new, only time will tell if this "better mousetrap" will conquer the world (i.e., "He who holds the sword", etc.). But, with the announced initial sales of over 135 systems to LensCrafters and TSO, the company is off to an auspicious start!

THERMAL KERATOPLASTY REVISITED

I recently read about news coming out of the 2009 ASCRS Meeting that John Marshall and his colleagues at King’s College in London were trying to use microwave energy to flatten the corneal curvature in a form of refractive correction.

Marshall reported that his group had hypothesized that the use of microwave energy could be targeted to “shrink” stromal collagen fibrils, both superficially and centrally within the cornea to correct myopia. This use of targeted microwaves could also be used in a peripheral ring to induce steepening of the cornea to correct hyperopia.

As I read the report, I was reminded that I had written about this very same thing nearly 20 years ago, in a “Technology Update” column written for Ophthalmology Management in October 1990. That column was titled, “The Rebirth of Thermal Keratoplasty (TKP)”, and told the story of Dr. Bruce Sands and his company Laser BioTech (which later licensed the technology to Sunrise Technology) trying to use targeted holmium laser energy to shrink collagen fibers, without thermal trauma, to flatten the cornea.

As background to this story, I also wrote about earlier attempts to use microwave energy to do the same thing, by a group that included Ralph Crump of Frigitronics (developer of the Softcon Lens – later licensed to American Optical) and Stuart Trembly of Dartmouth College. They were issued a patent that disclosed the use of microwave energy to shrink collagen tissue.

Nothing came from the microwave effort, and Sunrise Technology’s laser was marketed for a short time but the lack of precision in the shrinkage of collagen and a loss of effect lead to its demise.

The only company to take advantage of precise collagen shrinkage has been Refractec, with its Viewpoint CK conductive keratoplasty technique. This technique uses short pulses of radio-frequency energy introduced into short metal probes inserted into the cornea in a tight pattern for the correction of hyperopia.

Well, apparently there is a new company, founded by David Muller, the former CEO of Summit Technology and the above mentioned Stuart Trembly, called Avedro Inc. that is using microwave technology to successfully change the cornea's shape for correcting vision.

According to a recent filing with the U.S. Securities and Exchange Commission, the firm has raised an additional $10 million of equity venture capital funding to go along with its initial financing of $8 million.

Avedro's technology, called Keraflex, uses focused energy to reshape the front surface of the cornea. Avoiding the creation of a flap in the cornea or the need for the removal of any corneal tissue. Clinical trials will start shortly, followed by product launch in Europe.

As I learn more about this effort, I will report it in this space.



This column was published in the October 1990 issue of Ophthalmology Management.


TECHNOLOGY UPDATE


THE REBIRTH OF THERMAL KERATOPLASTY (TKP)

Irving J. Arons

There is an old adage that says, "What goes around, comes around". And it looks like it will hold true again in the case of trying to change vision by applying heat energy to the cornea.

Over the years, there have been several attempts to change the shape of the cornea without surgery, by acting on the collagen lamellar that makes up the bulk of the stromal layer beneath the epithelium. The earliest attempts that I'm aware of were the application of a radio-frequency heating device to the surface of the cornea -- the Los Alamos Keratoplasty Technique(1) in the late 1970s. There have also been mechanical and chemical/mechanical means tried as well. In the mid 1970s, Charles Neefe of Midland, TX was issued a series of patents that disclosed the use of drugs to soften the collagen, followed by the application of rigid contact lenses to reshape the softened tissue(2). Then of course, there is the application of a series of ever tighter rigid contact lenses to correct high myopia (orthokeratology).

More recently, two newer methods of shrinking collagen have surfaced. The first, discussed at the 1988 AAO meeting in Las Vegas, involves equipment and a technique developed by Dr. Svyatoslov Fyodorov, of the Moscow Research Institute of Eye Microsurgery. A special handpiece is applied to the corneal surface and rapidly heated to 60°C and held at temperature for 0.3 seconds. By applying an RK type pattern to the cornea, Dr. Fydorov claims to obtain changes of 2-4 diopters with his thermocoagulating unit for thermokeratoplasty (TKP). Several US ophthalmologists have been trained in the technique and reportedly, Alcon Labs has obtained a license to develop the instrument(3).

This past July, a Business Week article(4) drew attention to a patent obtained last November by Ralph Crump (formerly President of Frigitronics) and Stuart Trembly)a professor of engineering science at Dartmouth College). The patent discloses the use of microwave energy to shrink collagen tissue in the mid-stroma. This device is reportedly in early stage development, with testing proceeding on removed animal eyes.

The most recent technology disclosure, and perhaps the most interesting, is the use of lasers to selectively shrink targeted collagen sectors in the mid-stroma, by raising the collagen's temperature by about 23°C above ambient with microbursts of energy. According to Dr. Bruce Sand(5), CEO of this yet little known company, Laser BioTech, Beverly Hills, CA, the laser energy is used to cause shrinkage of the collagen fibers to about one third their length, without causing thermal trauma to trigger a wound response and thereby negate the shrinkage. Animal experiments have shown that with a controlled burst of energy, myopia, hyperopia, and astigmatism can be corrected without effecting either the epithelium or endothelium. True intrastromal shrinkage without thermal trauma and subsequent collagen coagulation has been accomplished using bursts of 3-10 millisecond pulses with relaxation intervals of 50-200 milliseconds, from a 2.1 micron holmium-doped pulsed YAG laser. The total energy density is up to 100 joules/sq.cm. According to Dr. Sand, their patent application covering the technique has been allowed and will issue later this summer or by early Fall.

Laser BioTech was incorporated in 1986, and in conjunction with Medical Optics, Inc., a subsidiary of Kaiser Electro-Optics and Kaiser Aerospace and Electronics, has built and tested the prototype design of the solid state laser. The privately held company is currently seeking corporate sponsorship to expand the animal trials and further develop this unique concept into a clinical instrument.

Look out Phoenix Laser, ISL, Summit, Taunton and Visx, there's another company with interesting new technology looking in through the crack in the door!

NOTE: In my July/August column, "Report from ARVO", I also noted that work on laser thermokeratoplasty was being investigated with a Ho:YAG laser by a research group in West Germany, headed by Theo Seiler.


Footnotes:

1. Rowsey et al, "Los Alamos Keratoplasty Techniques", Contact Lens Medical Jnl, Jan/Mar 1980.

2. A series of US Patents issued to Charles Neefe from 1973-1976.

3. "Hyperopic Surgery Kindles Heated Debate", Review of Optometry, January 1989.

4. Developments to Watch, "Clearing up Cloudy Vision -- with Microwaves", Business Week, July 2, 1990.

5. Private correspondence with Dr. Sand, August 1990.