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5 days on and John had not gotten an answer from the the client he presented to the week before. He did everything that was required of him. He followed the sales pitch correctly, asked the right open questions, gain

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

ed their interest and finally asked for the order. He was now waiting for the phone call of a life time. The “Yes John, we’ll fax over the booking form in a minute” call.

It was going to be John’s 200th deal and proba

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

Examples of combination products may in

ly the biggest one to date. Worth a whopping ?36,000,000 contract for the next three years, he would be set for life and known as the UK’s most results driven and highly successful corporate sales director. It had to

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 a deal. They had to sign the contract. This was his life. It was going to change his life forever. It would make him a star. For the first time in 25 years, he looked into the heavens and called the name of God; “Mak

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

e them sign the contract. Do this and I will never lie again, except when I sell again. This exception you must allow.“ John prayed as he engaged in a dialogue between himself and his long lost creator. He was told tha

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

Combination pro

he would get an answer within 4 - 5 day. 5 days on, almost 4;30pm and still no answer.

With deals like these, once you’ve given the price and gained a certain level of commitment, you have to step back and maintain t

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

e silence quo, making sure that you; the seller is not responsible for breaking it. It could mean the difference between sounding and coming across desperate which devalues your product or increasing the value of your

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

product by making the other party feel lucky to be doing business with you. You want them to think that although their business is important to you, you are not reliant on them to succeed. You have hundreds of highly

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

redible clients in need of your ongoing support.

John’s impatience and lack of self control was beginning to weigh him down. Anxiety was overwhelming him and he was feeling insecure about the deal. This caused him t

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

act irrationally.

This is what happens to us when we focus on self and not on others. John was about to lose a contract that took 2 years of nurturing, in literally minutes. He was going to pick up the phone and try

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

ullying them into signing a deal. His emotional and mental state was becoming unstable and unpredictable. There was no telling what he would say or do because of how desperate and frustrated he was. Frustration is a wa

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

Following aspects would a

rning signal. Your decisions and actions based on your current frustration is what delivers either positive or negative result. It’s okay to get frustrated sometimes, how you react to it is what makes the major differe

dd to the challenges in developing combination products:

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

ce. if John’s frustration was based on how this contract would benefit the client, then the fact that the client is delaying the project could be explained as a loss of valuable resources and business opportunities fo

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

the client. The client is then bound to see this as a selfless act and will value your business a lot more because of this. On the other hand, if John’s frustration is about getting the deal because of his own needs w

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

ithout considering the needs of the client, it becomes transparent and the client picks up on this as well. As a result, they feel John is just trying to sell the contract and make some extra money. This obviously does

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

not benefit the client and they walk away from the deal never to return to the meeting table again.

Make sure your frustrations are based on making a positive change. It’s a good feeling and most times, you’ll find ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

ers willing to support and help you. When your frustrations are based on self-preservation and selfish gains, there is a high chance you will end up frustrating others and making no progress at all.

Want to know what

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

happened to John’s contract? John is you. Knowing what you now know, what would you do?

Step 1
find the source of your frustration.

Step 2
establish the state of your frustration - is it negative or positiv

.

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

.

Step 3
look into the future - what would be the end result of staying frustrated.

Step 4
is it worth your time.

Step 5
Act on your analysis as long as it’s end results are not selfish.

Step 6

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

Companies that provide selfless information through particip

earn from your experience

Step 7
Take the necessary precautions to prevent it happening again

You start to overcome a frustrated life when what’s inside of you starts to change what you don’t like outside of 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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