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To visualise where you are going, is deeper and more sensory than anything you have ever done before. And

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

these are the skills of those who are able to create a vision you can really live and breathe. These peopl

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

Examples of combination products may in

e...

Are Focused

They are able to visualise in a focused and very clear way what 'perfe

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

t' will truly look like in the future.

Involve Others

Bring others into the contribution, suc

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

h that they might try things they might never have before.

Realise Core Strengths

Whilst bein

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

Combination pro

ultra-keen to grow and evolve, these people are true to the core strengths of the organisation and see th

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 future through that.

Take Time Out

Make the time for themselves and help others to free up

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

thinking room. And use it fully.

Play the Game

They encourage a creative environment and take

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

full part personally. They themselves set out to find ways of generating novel and fun ways to make this l

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

ive.

Think Big

Top class visions may even be unattainable within lifetimes and are often part

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

of a bigger legacy. many major corporations have 50-year (and more!) visions.

Use Their Senses

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

Following aspects would a

A vital part of Visioning is to be able to use all five senses as fully as possible and alos that wonder

dd to the challenges in developing combination products:

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

ful sixth sense, the one of intuition.

Are Knowledgeable

They keep their eyes and ears open a

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

d are fully aware of the possibilities. they suck in information and ideas to help form their thinking. Me

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

dia, other people, non-business analogies and metaphors too.

Put Aside Beliefs

Great visionar

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

es can shift themselves into a different dimension when looking at the future and leave their existing bel

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

Professional from academic institutions, pharmaceutical industries, health care indust

iefs outside the room.

Are Evangelists

They shout the outcome vision from the rooftops, relat

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

ing so well to all of their people. They explains it in words which mean something to all involved in futu

.

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

e success.

And taking the time out to share these visions, better still, involve your people right i

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

Companies that provide selfless information through particip

n the thick of it - builds teams, encourages contribution. Generates motivation, engagement and commitment

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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All too often we spend our days doing the same thing we did the day before. Just as often we find that the action of yesterday is not producing the results we are looking for tomorrow. None the less, we keep plodding along hoping that by some miracle we will see a different result from the same action.

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