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Once there was a time in business when you could experience a change and then return to a period of relative stability. Nowad

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

ays, changes occur constantly - one on top of another. We need to acknowledge change and realize that change is a continuous

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

Examples of combination products may in

ourney - a way of life rather than a one-time event that can be lived through. With considerable momentum and continuity buil

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

ing in our organization, it definitely can be said that nothing is ever absolutely certain (other than possibly death and taxe

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

).

These changes and challenges that we are encountering can at times bring added strain to business organizations. What is

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

Combination pro

ot always clear to us is how much more trouble we would be in for organizations failed to change. Often times people can have

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

a funny way of hanging on to old habits. In particular, we are often unwilling to quit doing what we can do well, even if it

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

s no longer valuable to our customers. It is easy for people to get stuck in the thinking that got them to where they are tod

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

y, even though that thinking cannot be used to get them where they need to be tomorrow. It is important that we continue to b

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

eak through our traditional thinking and avoid any prevailing mindsets, such as the thinking "it has always been done this way

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

" We need to continually focus our efforts beyond our "business-as-usual" thinking. As progress calls for each of us to chan

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

Following aspects would a

e, we need to remember that constant change is a way of life in business today. Together, we must simultaneously manage the p

dd to the challenges in developing combination products:

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

esent and plan the future.

Currently, some jobs are taking on totally new dimensions...making new demands...calling for new w

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

rk habits. We need to be willing to alter our mindsets as well as our techniques. Rather than continuing with the same old j

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

b behaviors that worked well enough in the past, we must learn new routines and make the necessary shift in our mindset so tha

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

our thinking is aligned with our new company mission and the new realities of the present work world. We all need to focus o

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

Professional from academic institutions, pharmaceutical industries, health care indust

r efforts on doing the right things for our customers. A key mistake can be ignoring how priorities and customer expectations

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

have changed. We can be focused on doing things right, but we really are failing to do the right things. What can we offer ou

.

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

customers that they will value and be unable to get from anyone else? We need to have an intense and unwavering commitment t

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

Companies that provide selfless information through particip

making a difference in the business' of our customers. It is important that we look at change as an opportunity...and use it

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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Medical representative sales jobs can be started at any adult age as long as one shows high potential for the selling environment.

Setting goals for the New Year does not necessarily mean making New Year resolutions especially if you tend to make yourself promises and not keep them. Here are some ideas to get your career moving forward in the New Year.

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