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As innovation changes from a hard to a softer kind of process, so the language must change to reflect this. Below are a list of terms that we commonly use in our project teams or businesses to

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

gether with a new vocabulary that we should all be coming to terms with.

Sales Pitch As project become more transformational than transactional we need to be talking about cr

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

Examples of combination products may in

eating a purpose not simply pitching an idea.

Visualisation Many of us visualise the outcome but it needs to be vocalised also. We all respond to different

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

stimuli so the desired outcome needs to represented in as many ways as possible to engage the whole project team.

Designer/worker/engineer When you are building something new

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

and exciting then call your team something exciting. They are all creators in their own specialist field.

Demand Demands very seldom work as intended. Create a d

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

Combination pro

ream and encourage others to buy in and follow it with you.

Content We all worry about the content of specifications and requirements documents. Consider the consequ

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

ences of every action you take. Does it enhance the clients experience, does it add comfort, safety or fun?

Scheme/Plan Instead of cumbersome plan, create a story an

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

d storyboard to engage the team and encourage their contributions.

Project Your project needs to be run along business lines so run it like a business with your

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

client as the major shareholder.

Team In line with the previous point, your management team are in fact a board.

Titles Avoid these like the plague

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

. If you must group people, do it according to the tasks that they are carrying out.

Jargon Abolish this, talking is all important to share knowledge and br

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

eak down barriers. If you use technical terms, ensure they are understood by everyone.

Communicate Treat communications as if you were campaigning, make sure that ev

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

Following aspects would a

eryone is convinced and understands the complex ideas that you are trying to get across.

Accomplish Do not dwell on accomplishing things. You have a dream to follow but remem

dd to the challenges in developing combination products:

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

er if you are innovating then there will be some failures to learn from. Not accomplishing is not a disaster, you are undertaking an adventure.

Question These are da

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

maging in large numbers. Encourage people to ask for advice or direction, not just question everything.

Doing Doing should be replaced by learning. This way

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

you have both action and the acquisition of knowledge.

Programme Do not think linearly. You will be embarking on a journey and the path may twist and turn on the wa

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

y.

Research If you are innovating you will be entering into uncharted territory on some occasions. Research cannot help you. Intuition must become part of your vocab

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

Professional from academic institutions, pharmaceutical industries, health care indust

lary.

Guideline Replace this with guidance, talking and a little intuition. No rigid procedures here!

Visitor A visitor could be a guest,

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

but do not take this too far.

Messages If you take the time to create message then you want them to be remembered so focus on creating memories, a subtle but helpful

.

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

distinction.

Present We often present our ideas and plans to people but in a collaborative environment we should be colluding or conspiring with all of our stakehol

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

Companies that provide selfless information through particip

ders.

History If you are keeping records, make it interesting, richer and full of knowledge. The record of your journey through your innovation project is Your Story

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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