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When shopping for a LASIK surgeon, the cost should not be your first question. Why not? Well, surprisingly low quotes will almost certainly turn out to be higher, and if they don’t you can assume that cheap or outdated eq

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

uipment was used, and/or shortcuts taken. A reliable and competent LASIK surgeon must invest in expensive equipment in order to deliver the best results for you. Besides that, you have one pair of eyes to last for life; d

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

Examples of combination products may in

on’t you want to give them the best treatment there is?

Here are the most important questions to ask your prospective LASIK surgeons (and yes, you should interview several before deciding on one).

Will you be doing the

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

entire process yourself?

You don’t want to be shuffled off to an assistant, or someone in training. It’s best to have your chosen doctor be the one who examines you to begin with, decides on the treatment plan, does the

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

LASIK procedure, and follows up with you afterwards. That way you know you’ll be in consistently good hands.

How many LASIK procedures have you performed?

The answer to listen for is a number over 500, and preferably ov

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

Combination pro

er 1,000. LASIK surgeons use computers to guide the laser beam, but who programs the computer? You want someone with plenty of experience at creating treatment plans, carrying them out, witnessing the results, and dealing

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

with any problems that might have arisen. If you know the name of the particular type of LASIK procedure you’ll be having, ask how many times the surgeon has performed that specific procedure.

Where did you receive your

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

training?

There are many tertiary institutions which train doctors in how to do LASIK. You could contact the relevant institution to ask about the surgeon’s academic career and performance.

Can you give me some referen

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

ces?

Most established LASIK surgeons can put you in touch with some of their previous patients, who will tell you about their experience and results.

What professional associations do you belong to?

A doctor who has se

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

veral professional memberships is more likely to be keeping up to date and in touch with his or her peers. It’s best to have a LASIK surgeon who is enthusiastic enough about his work to pay for those memberships, to go to

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

professional events, possibly take advanced or specialized training, and maybe even write journal articles or books about LASIK vision correction surgery.

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

Following aspects would a

If I have questions as we go, will you have time to answer them?

All doctors are busy people, but an organized and responsible doctor will have time to spend with you, to answer questions, calm fears, explain procedures,

dd to the challenges in developing combination products:

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

and clarify details. If you choose a LASIK surgeon who inspires your confidence, you can be calmer about the whole procedure, and will most likely follow his instructions at each step of the way, which will be to your be

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

nefit.

What is the name of the equipment you use?

You may not recognize the names, but write them down and do a little research afterwards. Get the full names, not just the company name, because there are often improved

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

models developed and you wouldn’t want a surgeon who is still using old equipment when precision is the name of the game in eye surgery.

What sort of follow-up will there be?

There should be a minimum of four follow-up

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

visits so the surgeon can check on your vision improvement. Ask if this same surgeon will do your follow-up too. Ask whether there might be follow-up procedures possible if you are not happy with the initial results.

Ho

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

Professional from academic institutions, pharmaceutical industries, health care indust

w often is the microkeratome incisor changed?

The microkeratome is a surgical instrument which cuts the little corneal flap so that the laser can work on the next layer down, the stroma. The incisor should be fresh for e

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

very patient. There are some “LASIK factories”, which process large numbers of patients as quickly as they can, and keep costs down in many ways, so as to make a bigger profit. Re-using the incisor is sometimes a way of k

.

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

eeping costs down.

What financing plans do you offer?

Although we warned you away from cost questions at the beginning of this article, of course you need to ask about it. Just don’t make cost your decisive factor in ch

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

Companies that provide selfless information through particip

oosing the surgeon. Most LASIK surgeons offer several ways of financing the procedure, so choose one with a plan that fits your budget and timeframe. Remember that in the long run, you’ll be glad you paid for quality work

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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