Advice You - Business

The success of outsourcing relationship hinges more on the pre-finalization stage rather than the miscommunication and misunderstandings during the process. The most common fallacy

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

about outsourcing decision to a BPO firm, say a call center in India, is to take it too lightly. Without giving a serious thought about the capabilities and promise of the provider,

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

Examples of combination products may in

the companies outsourcing their operations, often, choose a wrong BPO firm. Here, I will concentrate just on the two most common mistakes committed by the companies in selecting 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 correct business partner.

Mistake #1: I need references!

This is a common demand by every company, i.e., verifying the credibility of the call center by cross-checking fr

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

om the existing or past customers. This is a total giveaway as far as selecting the right BPO is concerned. I’ll explain how and why.

If I am asked for references and if I have an

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

Combination pro

iota of common sense of doing business, I will never disclose the references of unsatisfied customers – not even in my sleep! You can consider it from the other side as well. There

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

can be possibly two answers to this kind of query, (a) I’ll give you all the references of my satisfied customers; or (b) I don’t have any references, in which case I was not even e

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

ligible to bag your order in the first place!

The references are, mostly, of no help to you as a buyer but such inquiries from references can be of immense help to the call center

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

in question. They can be richer by a couple of million dollars if you just rely on all these positive references. Many a call center, India has produced, have mushroomed just by sho

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

wing few positive references to the prospective clients in the West. The result is unsatisfactory services and an indelible blot on the Indian BPO industry.

Mistake #2: Can I ta

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

k to your agents?

This is yet another query that is bound to benefit only the provider. To verify the credibility of the provider, the agents must be suitably trained to handle

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

Following aspects would a

the job. But what makes you think that I’ll put a novice on duty to answer your questions? Obviously, I’ll get the prospect to speak with my best agent on the floor.

The prospect

dd to the challenges in developing combination products:

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

has nothing to gain from asking these simple questions. This reminds me of the situation where you go to a shop and ask the salesman if the displayed products are good. Which sane s

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

alesman will ever say that the product displayed in the store is not good?

The correct approach

Now, where lies the solution to these obvious faux pas committed by the pros

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

pect? The verification of credibility of the call center is vital before awarding the contract. But committing the above mistakes are only going to benefit the prospective BPO.

The

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

way out is simple. Just speak to the man at the helm, the managers, the owners etc. Basically, speak to the top management. Ask them relevant questions about their jobs. See for yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

urself if the leader is capable enough to properly guide his employees. The questions like, what is their vision; How can they add value to your business; Will they do everything it

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

takes to handle your business like their own; can elicit all the information straight from the horse’s mouth, so to say.

The idea is to choose the provider that is run by people w

.

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

ith strong fundamentals & industry experience, rather than fly-by-night swindlers. Form a judgment based on the answers to the above questions and other relevant queries about their

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

Companies that provide selfless information through particip

business. This judgment should be your own as opposed to that of a third party. Always remember, it’s you who is doing the business and it should only be you whose judgment matters

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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