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In the history of architecture there has often been an unseen contradiction between what the architect wants to design and what the client wants built. Sometimes an architect

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

will get so wrapped up in his vision and personal aesthetic values that what the client likes and does not like becomes secondary, or is overlooked completely. When this happe

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

Examples of combination products may in

s the house or building created may win design awards and look beautiful to a trained architectural eye, but the client or people who have to live in it may dislike it intensel

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

. Often the owners or tenants will go back in and change things a second or third time to better suit their aesthetics or purpose.

At the root of this problem is the very nat

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

ure of architecture, to create. An architect is very passionate about the creative artistic aspects of his work. He wants to create something new and different and put himsel

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

Combination pro

and his vision into his work. Often, however, the growth and development of an architect involves the painful realization that their unique vision does not usually count for

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

ery much. The client, after all, is paying for it and has to live with the house or building long after the architect has finished and gone on to other projects. The architec

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

t is there to serve the client and not the other way around.

The other professions rarely have this problem. Doctors and lawyers are almost always acknowledged to be the deci

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

ion makers and authorities in their respective fields. Science and the written law are established and much less subject to interpretation compared to artistic values and visi

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

ns.

Unfortunately, the established architectural community and schools have more often than not made the problem worse. Architects are never made famous because of how well t

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

ey satisfy their clients. They are famous because of the unique, creative style or image that they have managed to present to the world. Architectural awards are given to des

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

Following aspects would a

igns or buildings that are creative and almost never to buildings that perform their function flawlessly or totally satisfy their clients. In many cases, world famous architec

dd to the challenges in developing combination products:

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

s have never had the opportunity to build more than a small handful of buildings because of this contradiction between client needs and the architect's creative vision.

If you

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

do approach a world famous architect with a project, it is pretty much assumed that you as a client are buying into that architect's creative vision 100 percent. You as a clie

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

nt become an extension of the architect's vision and not vice versa. Of course, the client has generally had ample opportunities to review the famous architect’s body of work

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

efore hand because of the exposure the architect has gotten in the media. You like his work and aesthetic values and hire him, or you don't. Of course there are architectural

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

Professional from academic institutions, pharmaceutical industries, health care indust

firms that are almost the opposite. They are highly client oriented rather than design oriented. They often become financially successful from client loyalty and referrals bu

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

t rarely get media attention or become famous because of the conservative nature of their work and business.

Ultimately the best solution for most established architects is to

.

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

balance the two extremes and become a teacher for the client. The architect presents the client with various design and style options and the pros and cons of each and listens

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

Companies that provide selfless information through particip

carefully to the needs and tastes of the client. This establishes a dynamic synergistic relationship. Together they decide the image and vision for the architectural creation

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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