Main Subject - Business

In the investment world there goes the saying – “the market is always right”. One of the meanings of this is that you do not have to be right 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

win a lot of money. Even if the market fundamentals would predict otherwise, when there is a stream in a certain direction you’d better go with it, or y

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

Examples of combination products may in

ou would face a terrible resistance.

Changes in organizations are dealing with the same phenomenon; the market – represented by the majority of the emp

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

loyees – are against change and so they will resist. And you should be glad that they do. If the majority of the people within the organization start ru

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

nning to an end (goal) that is unclear you should worry. However, you d? need momentum at some point in time to get things rolling. Much is to do about

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

Combination pro

alancing energy.

Most people do not favour changes. And they are right. It can be tiring. We all have our habits. We eat what we like and we do not try

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

too many new things. First of all because it costs time to search for new and exotic recipes. The new disrespects, to a certain extent, the old.

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

If you are to invent a new dinner each night, your companions at the table will raise the question whether yesterday’s food was not good enough. To res

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

ist a change is natural.

Yet, there are always some pioneers out there that see new opportunities. For instance a new technology that enables yo

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

u to save time or give you other benefits, new methods that speeds things up or other exotic features that are nice to have. But, how is it that this sm

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

ll group activates the rest? And what should your approach as a change manager be, especially in the start of the project?

As a manager you are in t

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

Following aspects would a

he middle. As always. The pioneers in front of us present some vision that is everything but sound and clear. Therefore it is called a vision. It is

dd to the challenges in developing combination products:

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

nothing until you have reached it and even then it is different than what you had thought it to be. So in order to activate people your job as a manage

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

r is to make sure the pioneers are not de-motivated and that the resistance is diminished at the same time. It is your job to link the two parties.

The

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

best way to do that is to tell two stories:

1. ‘If you go too fast the rest will never catch you up and we will all loose’ (present this to the

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

pioneers)

2. ‘If you always follow the market you will never win. Sometimes you have to take just that extra bit of risk’ (this message agrees best wit

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

Professional from academic institutions, pharmaceutical industries, health care indust

h the rest of the group)

At the end of the change ‘project’ the situation is reversed and it is your job to stabilize the situation. But most changes f

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

ail because the resistance in the beginning absorbs too much of the budget.

Again as with investments, there are people who feel the beginning of a new

.

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

trend, one-out-of-three that they are to soon – so a little resistance to go with them each time is alright. However, if they are right – and a good sa

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

Companies that provide selfless information through particip

les story could inform you – then you should better not wait too long to join them. You might end up with nothing.

© 2005 Hans Bool / Astor Whit

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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Church signs have been known to stop people on the side of the road to ask what they are. Outdoor church signs are mostly known for being right outside of the church with the thought of using it to attract new people to the church.

Learn how and why you want to avoid sending projects to a designer at the last minute. Your wallet and your accountant will thank you.

As we all know there is office gossip and rumours that abound in the workplace. Some of them start as a joke and some as a result of overheard misinterpretation of a conversation.

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