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There will come a time on every change project that you will wish you had read this article. The size and scope of the work does matter. Everyone today, especially in the larger organizations

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

, wants to forecast heroism. By that I mean they want to think that because they are who they are, or the organization is who it is you will then be able to do anything. Don’t make that mista

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

Examples of combination products may in

ke.

When setting up any change project, and remember all project work is change work, there are three parts you must balance to succeed. They are …

1. Scope
2. Resources
3. Time

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

These three elements form a triangle and must have equal sides. That means the length of each side must remain relatively the same throughout the project. Let’s address each individually then

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

we’ll tie them together as a whole.

Scope:

The scope of the work defines the boundaries of what you will work to change. The scope is your vision of the project. Are you going to change th

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

Combination pro

e processes of just accounts payable or are you going to reach out into other areas as you progress. You must carefully define the scope of the work in order to move to the next side of the c

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

hange triangle and that is defining the resources.

Resources:

The resources of your change effort are the people, outside support, in some cases materials and most of all the finances, the

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

money required to bring about the changes desired. Here is where we find the forecasting of heroism most common. Many leaders confuse sound planning with being macho. If you are the change le

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

ader don’t accept the assignment without a realistic resource plan or you are doomed to failure. The gun that will eventually shoot you for failing is already aimed at you at this point. You

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

must take the scope and support it with a realistic resource plan.

Time:

The third side of the change triangle is the by-product of the first two. Based on your vision, the scope, and the r

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

sources you have been given, the work will take a certain amount of time. You should get together your best and brightest as they say and given the scope of the work and your resources determ

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

Following aspects would a

ine how long you think the work will take and then double it … that is how long it will really take. Remember, time is the by-product of the first two.

Once you embark on your change journey

dd to the challenges in developing combination products:

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

inevitable ‘changes’ will surface. You will find things out you didn’t know and you may be tempted to add to the scope or speed up the delivery of the changes – don’t do it. Let me correct m

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

yself, don’t do it without balancing the change triangle. It is pretty simple to understand and do but it’s difficult to gain support to make it happen.

You see when the boss comes along and

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

says we have to finish the work in one year and not eighteen months and doesn’t allow you to match that change with a reduction in scope or an increase in resources then they just cocked 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

trigger of that gun pointed at you. It is that simple. That’s why 80% of all change efforts fail. They fail because of a lack of real leadership.

Real leadership doesn’t put the change proj

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

Professional from academic institutions, pharmaceutical industries, health care indust

ect leaders in a position like this to fail in the first place. If they are placed in this position real project leaders will defend the change triangle at all costs and make sure that their

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

‘heroic’ leaders know what they are getting themselves in to in the first place.

Change leadership is simple to understand, difficult to deliver. First define the scope, based on the scope d

.

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

etermine the necessary resources and the combination of the two will give you the timeline. Once you are approved and embark on the journey keep the three sides of the change triangle in bala

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

Companies that provide selfless information through particip

nce. When the big dog comes and says speed up make sure you’ve laid the groundwork that they know to speed up requires a scope shrink or an increase in resources. It’s that simple or you fail

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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