Advice You - Business

There’s a park I walk through on the way home each day. It used to be a very pretty park with vast areas of green freshly clipped grass, commemorative benches with

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

gleaming plaques, pristine toilets that won countless awards, trees that have been there for decades and freshly painted playground equipment for the kids to climb

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

Examples of combination products may in

over.

About a year ago I happened to notice that one of the windows of the toilets had been smashed, I could have been wrong, but it looked like someone had thrown

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

a stone through it. I tutted to myself and continued on my way. The next day as I was walking, I noticed that someone had added to the broken window with another a

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

d someone else had scrawled their name next to it in giant, sprayed on letters.

Over the year, things have got worse. The green grass has yellowed and is littered

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

Combination pro

with rubbish, the benches have become worn and broken in places and the playground is more rust than paint and seems held together by the marker pen graffiti.

A sa

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

d tale of urban decay you may be thinking, but what the heck has it got to do with sales?

The thing that tripped off this series of events was the broken window. I

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

would argue that had that broken window been fixed the day after it’s breaking then the person who broke the second window and left graffiti would not have done so.

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

Consequently the park would not have become an area where it was ‘ok’ to treat with disrespect and it would not have fallen into steady decline.

Again I hear you

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

thinking, I get it, but what the heck has that got to do with sales?

Let’s say you have a team and in the majority they are pretty successful with sales. They are

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

ll doing ok and you can see that their skills are developing progressively. However, there is one member of the team that is not on board with the concept. They are

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

Following aspects would a

disruptive, they complain, they challenge every product by comparing it negatively against competitors and they do their utmost to undermine the process at every o

dd to the challenges in developing combination products:

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

pportunity.

Many managers will ignore this person in the hope that they will get so fed up that they move on to another part of the business or even to the competi

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

tors they so admire. They’ll invest little time in them and ignore their development. This is a mistake. The person we have described is your ‘broken window’ and al

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

the time they are left ‘un-mended’ they will encourage the same negative behaviour in others, until your business looks as tired and worn as the park I go through

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

every night.

Other people will start to model the behaviours displayed by the broken window and you will notice a steady decline in sales development, after all, ’

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

Professional from academic institutions, pharmaceutical industries, health care indust

if they can get away with it, maybe I can too’. It is far easier to change the methods of one than it is to alter the habits of one hundred.

I would even go furthe

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

than this and say that they are the catalyst and, if turned around, they will move your culture of sales on to the next level. When negative obstructers, who gener

.

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

ally court a lot of influence, become flag wavers for the business, you have found a method of ensuring that things happen even when the boss isn’t looking.

Like m

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

Companies that provide selfless information through particip

ending a broken window, it’s not fun and nobody wants to spend the time, money and effort on it, but it’s a lot better than having to re-develop the whole damn park

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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