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The real secret of success in business I picked up some clients in my cab the o

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

ther day: a millionaire business owner, one of his top operatives, and a business cons

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

Examples of combination products may in

ltant. They had just been in a difficult meeting with some important clients, which t

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

ey had expected to have been a very bad experience. Each party had come to the table

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

ith their own agenda. Stripped to basics, one party thought the other owed them money

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

Combination pro

which the first totally disagreed with.

On the way to the airport we discussed a litt

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

le about their meeting, how it went, how they felt as a result: no details, just the b

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

nes of their day (cab drivers, after all, have to be the very souls of discretion – co

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

fidentiality is rightly expected). They talked about some of the personalities that 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

ey had encountered, which made for entertaining listening, and a little about the reso

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

ution. From my own experience of similar situations in a former life in business, I su

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

Following aspects would a

ggested that the important thing to remember in all transactions was that, at the end

dd to the challenges in developing combination products:

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

f the day, the meeting is between individuals – people who are there to earn a living,

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

people who really just want to be at home with their family, hobbies and philosophies,

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

people who are just that – people first and foremost. So, if you treat your ‘opponent

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

as an individual, just like you – treat them as you would be treated yourself – then

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

Professional from academic institutions, pharmaceutical industries, health care indust

meetings, business exchanges, disagreements become much easier, whatever the situation

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

People become more reasonable, mutually satisfaction is achieved more easily, and pe

.

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

ple go home with less stress, so that they can get on and enjoy life! This suggestion

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

Companies that provide selfless information through particip

as greeted by the consultant with: “that’s a business secret that too few people know!

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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Perhaps you have seen the Vonage commercials on TV, as they are very entertaining and fun to watch. They are similar to Americas Funniest Home Videos. The tagline is always the same; Stupid Things People Do.

In the real world you create your brand without too much effort. People judge you by your physical presence: by your office, your clothes, your stationery, your advertising and your voice on the phone. In the virtual world, you lose all those valuable cues which tell people how to pigeonhole you. You must replace them with something. Here's how to create an online brand.

Lean manufacturing is a system based on people. When people leave an organization the wealth of knowledge that person has can not be transferred completely. Especially the synergies of the teams will be lost.

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