Main Subject - Business

So you are a business owner or a customer service representative and you ha

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

ve a customer who is calling you with a complaint or a problem with your pr

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

Examples of combination products may in

duct or service? What should you do about your customer and their call?

Th

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

e first thing to do when your customer calls with a complaint is to stop; 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

at is to defy everything that your brain, your heart, and your emotions tel

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

Combination pro

ls you to do. Your brain, your heart, and your emotions tell you, no, they

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

cream out to you to-start talking, defending yourself and your company and

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

to justify or to explain what has happened to your customer. Rather, what y

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

u should do is...

BE SILENT AND LISTEN!

Yes, Stop, take a big deep breath

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

, be silent and listen to what your customer or client has to say!

Even if

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

they are wrong!

Even if you are right! Allow your customer to fully explai

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

Following aspects would a

what has happened, how they feel, and why they are feeling that way. Show

dd to the challenges in developing combination products:

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

your customer that you care about them and that you want to help them by li

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

tening fully to their complaint or their issue. Once they are done speaking

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

the first words out of your mouth should be something to the effect of, "T

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

at's horrible," or "that’s terrible." Then inform your customer what you ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

e going to do to help them get their problem or issue resolved.

You will b

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

glad that you took the time to listen to your customer because what you le

.

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

arn just might help you solve their problem or complaint easily and painles

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

Companies that provide selfless information through particip

ly for you as a business owner and in turn create a loyal customer for 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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Main Subject - So, Your Customer Has A Complaint - Part 1

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