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This sounds easy enough, but to identify the gaps, you need an intimate understanding of the current state and

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

future state of the firm at many levels.

Articulating a clear current state that everyone can agree to is a

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

Examples of combination products may in

crucial starting point, but it's easier said than done. Often times, when a management team follows a process

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

to thoughtfully and critically examine the current state of affairs, it soon becomes obvious that not everyone

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

sees the present situation the same way. When you start to peel back the layers, you may realize that apparen

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

Combination pro

t agreement was often based on untested assumptions and supposition. If you are serious about developing any k

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

ind of strategy with a hope of successful execution, don't skip this step!

Articulating the desired future st

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

ate means getting very clear on the specifics of your vision. The easiest breakdown is to start by looking at

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

people, process, and technology. Get very clear on the specific components you would like to see in place for

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

each for a specific point in time in the future, and then document it. Similar to documenting your current sta

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

te, this process helps to uncover many of the misunderstandings about your desired future state...before it's

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

Following aspects would a

too late. In my experience, getting agreement on vision at a high level is relatively easy. It is only when yo

dd to the challenges in developing combination products:

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

u start to document the details that new questions arise and need to be discussed and answered. Again this is

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

much easier at this point, than after execution begins. The biggest side benefit of clearly articulating your

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

desired future state is that the output will feed your business and system requirements, and your project plan

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

s.

Finally, with your current state and future state clearly documented, understanding your gaps is really ju

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

Professional from academic institutions, pharmaceutical industries, health care indust

st an exercise of defining the difference between where you are today, and where you want to be. Essentially,

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

you want to work in the categories that make the most sense to your strategy and analyze the gaps. Look at mag

.

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

nitude, resources required, and whether the gaps are technical versus cultural, etc.

With a well-documented a

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

Companies that provide selfless information through particip

nd agreed to gap analysis in place, your chances of successfully executing your strategy are greatly enhanced.

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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