Main Subject - Business

If you own a business, sooner or later you are going to run into a situation where you screw something up. This situation can be an op

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

portunity or disaster all depending on how you handle it.

To error is human, or so the clich? goes. If you are older than about six m

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

Examples of combination products may in

nths old, you know this is one of those clich?s that is utterly and totally true. Some would even define experience as learning from y

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

ur mistakes. Well, the same thing goes for your business efforts.

You may be the most diligent and hardest working person in the worl

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

. This will not insulate you from bonehead moves and mistakes. Sooner or later, you will fail a client or customer. You may not even r

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

Combination pro

ealize it until they call you. It may be something as simple as forgetting a meeting or something more serious such as missing a deadl

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

ne. How you handle these situations can kill your business or form long lasting relationships to your benefit.

Everyone makes mistake

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

. This sounds obvious, but most businesspeople seem to forget this when faced with a problem. It happens. In fact, the client or custo

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

er calling to complain certainly has done something similar. If you address the situation correctly, you can turn a problem into a pos

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

itive. If you don’t, you can lose a client and damage your reputation. If you are really lucky, you will get sued!

As an attorney, I

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

an’t tell you how many times I have defended business clients in litigation because of how they handled a problem with a client. Inste

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

Following aspects would a

d of addressing the problem, business people tend to bury their heads in the sand as though it will just go away. Nothing infuriates a

dd to the challenges in developing combination products:

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

client or customer more. If you have clearly made a mistake, no lawyer is going to save you. If you failed to deliver a big shipment o

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

n the due date, there is nothing I can say to a judge or jury that is going to save you.

When you clearly have made a mistake, there

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

s a proper course of action to take. First, deal with it up front and center. Admit the mistake and apologize for it. You would be sur

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

rised how far an apology will go with an unhappy client or customer. It takes an adversarial situation and turns it into something les

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

Professional from academic institutions, pharmaceutical industries, health care indust

.

The next step is to come up with a solution to the problem. You may have to bite the bullet on the solution, but it is going to be

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

cheaper than hiring an attorney. It is also going to do worlds for your reputation. A business that “makes things right” is one that p

.

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

ospers. This is particularly true if you are in an industry where most businesses do not act as such.

If you are having a dispute wit

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

Companies that provide selfless information through particip

an unreasonable client, then defend yourself. If you clearly have made a mistake, however, make it right and clients will forgive you

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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