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What is a culture for success? How do we ensure that we get the best results from the people we work with or for? Many people think of success in organiz

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

ations as belonging solely to the marketing dept – “we’ve brought in $10million in sales” or finance – “our stock price has doubled in the last six mon

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

Examples of combination products may in

hs.” But each of us is responsible for the success of our organizations.

No matter what department we work in.

Creating a culture for success requires

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

hat we look at everything we do and see how it fits into the whole. Then, we look to the processes that could be changed or improved in order for the org

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

anization to be successful.

These 4 steps can add up to winning big.

Communicate optimism.

Begin by looking at yourself. Do you radiate success? When

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

Combination pro

ou come to work do you hum “take this job and shove it” or do you energetically belt out “don’t rain on my parade”? Are you optimistic about how the day

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

will go and do you communicate that optimism to everyone you come in contact with? It doesn’t take much to communicate optimism. A smile – an encouraging

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

word – a zest for the work at hand – they all help to convey positive demeanor.

Don’t blame the competition.

So you’ve got really tough competitors ou

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

there? Sneaky, underhanded, unethical- making up rumors about you- they’re just looking for any opportunity to steal your clients away from you. I don’

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

think so. Competition will always be with us. And not everyone will do business the way you want to. But…how did they get it in the first place? What

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

as missing in your product or service? Look at your weakness and confront it. Then do something about it. Your competition can’t steal business from you

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

Following aspects would a

. You don’t own those revenues, the clients do. It’s up to them to make sure they’re getting the best product or service or value for the dollars being s

dd to the challenges in developing combination products:

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

ent.

Identify simple improvements.

You don’t have to concentrate on just the big jobs that need to be done. Sometimes the best improvements are the s

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

mple ones. A rain drop doesn’t end a drought but many rain drops will.

Never say “can’t”.

This is a personal favorite. I’ve sat in many meetings listen

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

ing to people say “can’t” to the solutions that would create successful products or promotions. For example, you don’t know if the marketing campaign yo

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

are working on is bringing in the specific type of accounts you wanted because you can’t mine the database properly. Well, figure out how you can. Even

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

Professional from academic institutions, pharmaceutical industries, health care indust

f a solution is an up-front cost- figure how much will it cost you not to implement. Don’t be afraid to use simple solutions. Can’t automate a process ri

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

ght now? Figure out how it can be done by hand. There is always a work around solution to a problem.

Creating a culture for success isn’t really that di

.

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

ficult. It doesn’t always require in-depth market research or focus groups. It does require that each person in an organization take personal responsibil

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

Companies that provide selfless information through particip

ty to be as successful as possible. Whether it’s a business, social, religious, or fraternal organization, creating a culture for success starts with you

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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