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Caveat emptor – buyer beware! There are facilities which offer LASIK at lower prices, and it may look attractive at first glance. But how do they manage to perform a highly sophisticated medical procedure

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

which requires very expensive equipment and highly trained staff and surgeons, at a cut-rate price? Accepting modest profits? That might be true in an idyllic world. No, many facilities are in business t

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

Examples of combination products may in

make a good profit by processing lots of patients as quickly as possible. They try to attract patients by offering low prices. The low prices attract only a certain kind of patient: one who’s looking for

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

a bargain rather than for a quality surgery. Consider how important your eyesight is. How would you feel if it were damaged by someone’s neglect, carelessness, or lack of expertise? How much is it worth t

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

you to protect your eyesight and entrust it only to careful, attentive doctors who use only the best equipment? Compensating for the low fees A facility which charges low fees has to make up for that los

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

Combination pro

of revenue, and they do it by lowering their costs:
· Buying or leasing an old, cheaper laser which is less accurate
· Purchasing cheap equipment
· Sterilizing equipment less often
· Re

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

-using things such as latex gloves, which should be fresh for each patient
· Giving you less surgeon time, since surgeon time is highly trained, and therefore expensive
· Paying lower wages, which

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

means hiring less skilled staff
· Laying unexpected extra charges on you for such things as follow-up appointments or anesthesia (hidden costs)
· Performing only a brief and perfunctory initial ex

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

mination of your eyes to determine if you’re a good candidate for LASIK
A good outcome is surely what you want? If you go ahead with a 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

ctive.html">LASIK surgery without first being established as a good candidate for it, you’re inviting a disappointing outcome and even some extra personal risk. Scenarios to avoid
· A good candida

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

e must have the right corneal thickness. So picture the surgeon, hurrying through your procedure so as to get to the next patient and meet his or her quota for the day. He could make a mistake cutting the s

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

Following aspects would a

all flap on your cornea, not knowing that your corneas are too thin for a LASIK surgery. If it’s cut too thick for your eyes, the tissue underneath could be damaged.
· You’ve had your cheap LASIK proce

dd to the challenges in developing combination products:

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

dure. You’re getting ready to leave and because the facility is under-staffed, nobody gives you the antibiotic eyedrops you should use for a few days. You wake up the next morning with one eye sore and swol

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

en. Follow-up appointments cost extra. But you pay the fee and see a surgeon’s assistant who informs you that your eye is infected and after waiting to see the doctor, you learn that further surgery will

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

ave to be scheduled to correct the small flap’s position.
· You’ve had your bargain LASIK surgery and the next morning you wake to find your eyes very dry and scratchy. You’ve always had a tendency tow

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

ards dry eyes, and in your brief pre-op exam, nobody told you that LASIK can make a person’s eyes extra dry. You call and ask about it and are told, Sorry, that’s a risk of LASIK and if you had dry eyes you

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

Professional from academic institutions, pharmaceutical industries, health care indust

should have told us. A quality LASIK surgeon
Choosing a LASIK surgeon is a time to choose quality rather than a bargain. As so often, you get what you pay for. A quality LASIK surgeon will:
· Tho

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

oughly examine your eyes to determine if you’re a good candidate
· Answer all your questions to your satisfaction
· Offer a variety of payment plans
· Spring no hidden costs on you
· Per

.

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

form your surgery himself
· Follow-up with you himself, the next day, and at intervals for a full year
· Use only the best equipment and materials and keep them scrupulously clean
· Hire only

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

Companies that provide selfless information through particip

skilled staff
With only one pair of eyes, don’t you want to take good care of them? Interview several LASIK surgeons until you find one that you feel you can trust with this crucial aspect of your life

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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