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Architecture is (normally) about buildings, cities and infrastructure (and the

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

like). You can see it around you and everybody has an opinion about it. You e

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

Examples of combination products may in

ther like the style of that building or you don’t and all the nuances in betwe

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

en.

Business is less visible but also there – everybody has an opinion about

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

t. You should make more profits, cut your costs, build an infrastructure and c

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

Combination pro

onstruct an organization that formalizes the (human) interaction, etc, etc.

I

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

we do all that, why bother about calling it business architecture? Well you s

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

houldn’t but some concepts will help you with issues that most managers are de

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

ling with:

Coherence. How do we make sure that what we invent on on

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

e end will fit with a solution at the other end.

Balance. How do we

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

now whether we are using all our talents and not only a small part of them.

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

Following aspects would a

Overview. What the hell are we doing anyhow. Our business have become s

dd to the challenges in developing combination products:

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

o complex that I’m wondering if all elements point in the same direction to me

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

t that goal.

So architecture can help us. The nice thing about arch

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

itecture is that you can look at one company and discuss about STYLE, FUNCTION

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

and MATERIAL or construction. Three elements you continue to see (in recurring

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

Professional from academic institutions, pharmaceutical industries, health care indust

patterns). Style is the most important, because it drives your business. It

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

s not only the driving force behind marketing, but also behind, sales, product

.

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

ion, human resources and IT. So if you have found your style, the first proble

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

Companies that provide selfless information through particip

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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