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A very smart attorney I know paid $7,000 for a roof repair, only to have the roof leak the next time it rained. The contract

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

or stalled, made excuses, but never did a thing about it. Anyone can have these kinds of problems when having repairs or imp

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

Examples of combination products may in

ovements done, but to make it less likely, avoid the folowing mistakes when hiring a contractor.

1. Not knowing what you wa

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

t. If you don't know what you want, you might not like what you get. Also, if you change your mind and change the job halfwa

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

through, the contract - and price - have changed (Hint: it won't get cheaper). Know clearly what you want done.

2. Not get

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

Combination pro

ting everything in writing. You don't want to hear, "I didn't say I was going to include the gutters."

3. Not having dates

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

n the contract. Did you want it finished this year? You better have it in the contract.

4. Paying too much up front. A depo

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

it may be a reasonable request when the contract is signed, and money for materials prior to the start date. Never pay in fu

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

l before the job is finished.

5. Hiring unlicensed contractors. Actually, this can be okay, if you know what you are doing

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

(and he does). The license doesn't mean you get expertise, but it does mean you get leverage. A contractor will right his wr

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

ngs to avoid losing that license.

6. Hiring the first one in the phone book. Ask friends who had work done, or the owner of

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

Following aspects would a

a hardware store. Find a recommendation based on a similar job to yours.

7. Thinking there will be no problems. Weather del

dd to the challenges in developing combination products:

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

ys, employees quitting, and more will happen. Having problems is okay, but it's not okay if the contractor can't work out th

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

e issues to your satisfaction.

8. Expecting neatness. Believe it or not, it is sometimes efficient to leave things laying w

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

ere they'll next be used. There will be messes, so prepare accordingly. Cover things if it will be a dusty job, for example.

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

Also be clear in the contract that the jobsite will be cleaned up at the end of the job.

9. Not having penalties in the con

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

Professional from academic institutions, pharmaceutical industries, health care indust

ract. This is important on large jobs. It's one thing to say "Work to be completed by May 2nd," but better to add, "$100 per

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

day to be deducted from the contract price for each day the job is unfinished beyond May 2nd." That's what I call a motivat

.

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

onal clause.

10. Thinking contracts will prevent problems. They help, but unreasonable people on either side of a contract

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

Companies that provide selfless information through particip

an ignore them, or use "literal readings" to make things even worse. Find someone you can work with, and keep your eyes open

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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