Main Subject - Business

What if your customer service policy says one thing and your management says

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

another? Recently a friend in the retail business told me of a number of case

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

Examples of combination products may in

when a customer would ask for something that was specifically against the po

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

licy of the store, for example, their money back after the 90 day deadline, e

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

c. In every case, after the Customer Service rep said no, the customer compla

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

Combination pro

ned to the Store Manager, who immediately overrode the policy and gave the cu

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

stomer what they wanted.

What you need to do is COORDINATE YOUR POLICIES.

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

Overriding the very rules you put in place only makes your front line sta

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

f look bad. Either change the rules or stop changing them every time someone

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

whines loud enough.

Now, I have no problem making the customer happy, but wh

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

have a policy you don't enforce? Would it not be better to drop the rules (s

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

Following aspects would a

nce you don't enforce them anyway), and adopt a "make every customer happy" p

dd to the challenges in developing combination products:

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

olicy?

"But Rob," you say, "then everyone would take advantage of us!"

Not

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

ecessarily.

Yes, they may tell their friends about your fabulous return poli

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

y. But think about this: What happened when that complaining customer got wha

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

t she wanted? She was happy. What do happy customers do? Tell others about th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ir experience.

What would she do if you sent her away fuming? Tell others ab

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

ut her experience.

Which story would you rather have her tell her friends?

.

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

Like everything else when you are providing a service CONSISTENCY IS EVERY

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

Companies that provide selfless information through particip

HING. Everyone likes special treatment, unless it's not happening to them

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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