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I have sat through many lectures, seminars, classes, and presentations on change. They are often different from one another and frequently

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

present different theories on the need for change, the "x" steps to successful change, and how to overcome the obstacles to change. No ma

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

Examples of combination products may in

tter how dynamic the instructor was, or how easy it was to follow the logic of the presentation, by the time I arrived back at my desk, 60

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

% of what I was exposed to was lost. I have a similar experience when I read a book or an article about change and in this case I loose 80

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

% by the next day.

The most effective way to understand change is to experience it. We all have preferred learning styles. Some people pr

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

Combination pro

efer to read text material as distinguished from people who prefer to watch a video. Some prefer to listen to a tape or lecture, while oth

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

ers need small groups to ask questions. There are those who have a need to interact through discussion and some like to immerse themselves

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

into the heart of the activity. This last style is called kinesthetic learning and while not all people like to learn this way, it is gen

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

erally acknowledged to be the most effective.

Here is the challenge; how can you immerse people in a change process that is relevant to t

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

he business environment? ProfitAbility Business Simulations, a UK based firm has created just the right vehicle. It's a simulation that pu

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

s participants into teams with each running a division of a large company. Each division starts out in the same place. They are failing to

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

Following aspects would a

satisfy their customers, losing money, experiencing unclear communication between departments, and engaging in redundant and often meanin

dd to the challenges in developing combination products:

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

gless tasks. Participants are each assigned to one of four departments in their division and are oriented to the "way we have always done

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

it." Since it's an existing business, there is product that needs to be produced to meet current demand, administrative tasks to be comple

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

ted, orders for the next business cycle to be obtained, and a constant need to for new product and services to be designed. Of course ther

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

e is never enough time to accomplish everything . . . so the pressure increases.

If any of this sounds the least bit familiar, then the d

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

Professional from academic institutions, pharmaceutical industries, health care indust

esigners have it right. Through the learning experience, participants must make the changes to their business practices to reach profitabi

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

lity and improve customer satisfaction ratings in each of their three product lines and all within three business cycles.

There is usuall

.

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

y a need for change but it is often difficult to move out of our comfort zones and thus we resist. There is nothing like a high pressure,

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

Companies that provide selfless information through particip

exhilarating, and fun experience to move us off our cushions. Create enough discomfort with options for relief, and watch the changes flow

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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Why start a car rental business? Well a rental car company makes a lot of sense for many reasons, not the least of which is because rental cars are utilized by many companies for their employees, and for pick-up and drop-off services.

Yahoo is a known brand. Google is a respected brand. We can go on and on, but how can you build a brand seeing you don't have even a tiny fraction of the funds available to these giants?

If you really enjoy playing video games and you find them a challenging form of entertainment why not consider a career in the video gaming industry. If you are going to be working at something for 40 years or so don't you think it sounds like a good idea to choose something you enjoy doing?

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