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I remember getting hired as an executive before opening my own advertising company. I worked for this guy who at the time I thou

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

ght was a terrible manager. The truth is he happened to be one of the smartest managers I had ever met.

Here’s why….

He had ve

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

Examples of combination products may in

y little advertising sales ability, and couldn’t close a sale if his life depended on it. What he did have however was the knack

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

to hire the right people to do the job for him. What most of the employees did not know was he had talked his way into becoming

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

n equal owner for no money down.

When he spotted potential in a person, but they lacked the experience, he would ask a sales pe

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

Combination pro

son to do him a favor. Since there was no salary and everyone worked on commission, he would get them trained for free. He might

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

say to the salesperson I am not sure if this new person will work out, would you show him/her a few pointers, and let me know wh

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

t you think. The next day he might take the sales person out for lunch, or to the club, and talk about this new person. Then he

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

ay perhaps say something like “I am going to be very busy over the next week with suppliers, could you just watch over this pers

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

n a bit, and help them now and then if they need it. I would really appreciate it”?

He knew how to give back also, great perks

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

ike cash bonuses, weekend luxury trips, or for top people he would lease fancy cars. He would treat these people like gold, and

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

Following aspects would a

veryone else working there would want to be part of his so called “Inner circle”.

I remember one day a new person actually went

dd to the challenges in developing combination products:

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

to his office for help. He was trying to close a sale with someone on the phone, but having trouble. The man actually looked up

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

t him and said “I am eating my lunch right now”. The person said “I am so close to this sale, but I think he needs a second voic

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

”. The manager said you can do this on your own, and if you are going to disturb my lunch make sure it is with a closed sale. Ab

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

ut ten minutes later the person comes back to say “I closed the sale”. “The manager says “congrats, I knew you could do it”. The

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

Professional from academic institutions, pharmaceutical industries, health care indust

salesperson feels confident and is on the way to becoming part of the inner circle.

The point to this story

To be an excellent

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

business person it is not about working hard all the time, but working smart. The idea of going into business on your own is to

.

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

ave a plan, hire the right people to execute it, and be an excellent administrator. As you can see from the story you do not hav

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

Companies that provide selfless information through particip

to be an expert in every aspect of your business, but be smart enough to hire the right people. So don’t work hard, work smart!

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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