Advice Pool - Health and Fitness

Wavefront-guided LASIK uses Wavefront technology to customize the surgery precisely to your eyes. Traditional LASIK and corrective lenses can correct common

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

vision problems including nearsightedness (myopia), farsightedness (hyperopia), and astigmatism, but cannot address other problems with quality of vision. H

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

gher order aberrations can cause vision problems such as halos, glare, decreased contrast sensitivity, and shadows. These problems normally do not affect vis

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

al acuity (how you test on the eye chart) but affect the quality of what you see in real life. Higher order aberrations can actually be exacerbated by tradit

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ional LASIK surgery.

So what are higher order aberrations? As they relate to your vision, they are infinitesimal imperfections that create minute changes in

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

the light rays that pass through your eye. These minute changes in the light rays affect the quality of your vision (even with glasses or contact lenses) al

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

hough you are probably not even aware of the difference. In fact, the impact on your vision may be so minor that it doesn’t even show up in an eye exam.

Ev

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

en though these imperfections are minute, eliminating them through Wavefront-guided LASIK will make your post LASIK vision so clear and crisp that you will b

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

amazed at the difference. Many people who have Wavefront-guided LASIK can see even better after the procedure than they could with glasses or contacts befo

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e the procedure.

Wavefront-guided ablation uses the same technology that has been used to adjust high-powered telescopes for years. During a Wave Scan light

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

is sent into the eye and then measured after it has passed through the visual system. The result is a 3-D map, called a wave print, which pinpoints aberratio

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ns and is accurate up to hundredths of a diopter. The map is then used to precisely guide the surgery. Previous methods were only accurate to 0.25 diopter st

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ps.

Higher order aberrations can only be detected during a Wavefront evaluation. Myopia and hyperopia (sphere aberrations) and astigmatism (cylinder aberrat

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

on) are low order aberrations. They can be safely corrected with traditional refractive surgery.

Not all patients are good candidates for Wavefront. In some

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

cases Wavefront ablations are deeper than traditional refractive surgery, so those with thin corneas may not be eligible. Any type of refractive surgery can

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

increase higher order aberrations. This is why some patients see halos or lose contrast sensitivity after refractive surgery. Wavefront-guided LASIK carries

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

much lower risk of creating higher order aberrations. In fact, the main advantage of Wavefront-guided LASIK is

Wavefront-guided refractive surgery is more

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

expensive than traditional refractive surgery, but it has many benefits including:

· More likely to achieve 20/20 vision or better (in fact, many patients w

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

o have Wavefront-guided LASIK end up with better than 20/20 vision)
· Less likely to lose best-corrected vision
· Less likely to lose vision qualit

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

At the very least you should have Wavefront diagnostics before undergoing any type of refractive surgery, so you know what the risks are and what to expect

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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In the previous article, the author dealt with Part 7 of the Baldrige Values and Concepts – Managing for Innovation. This Part 8 issue will share his research on Managing by Fact: one of the Eleven Values and Concepts of Malcolm Baldrige Criteria. He compared the direction set by the CEO of the researched companies and CEO of Baldirge winners.

This real estate postcard idea is brought to you by Brandon Cornett, the Texas Department of Transportation, and the City of Cedar Park, Texas. If that seems like an unusual trio for postcard marketing advice, let me explain.

Our website, Best Of The Home, has been listed in the Open Directory Project (ODP) for over a year. Recently, I conducted a search of the ODP for my site, to update it, and found that it was no longer listed in any category.

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