Advice You - Business

There are many differences between managing mature markets and new ones, where innovation plays a central

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

role. In existing and mature markets companies follow the principles of good management. They protect inte

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

Examples of combination products may in

llectual property, try to be the first to market, invest in internal capabilities and superior technology.

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

In emerging and innovative markets, however, a completely different managerial mindset is required. Comp

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

ting in those markets, contrary to what most people believe, is not about having a superior technology.

I

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

Combination pro

t is beyond discussion the fact that technological excellence is a building block of competitive advantage

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

in most industries. In emerging markets, however, superior technology is neither necessary nor sufficient

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

to win.

The introduction of the Computer-Assisted Tomography systems illustrates the point. The first CA

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

scanner was introduced in 1972 by EMI, a British firm that patented all the key technologies involved. Th

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 system basically transferred X-rays and other diagnostic information into a three-dimensional computeriz

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

ed image.

After a couple of years established manufacturers of medical equipment, including General Elect

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

Following aspects would a

ric and Siemens, jumped into the new market. EMI, however, did not feel threatened. It had undoubtedly the

dd to the challenges in developing combination products:

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

best technology around; its scanners had a much higher definition and more advanced features.

General Ele

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

ctric knew it could not compete head to head with EMI, it decided therefore to invest in scanners with a f

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

aster scanning speed, at the expense of image quality. After some years General Electric had conquered 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

vast majority of US market for CAT scanners, despite its inferior technology.

Over that period all the m

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

Professional from academic institutions, pharmaceutical industries, health care indust

jor hospitals were having critical problems with patient throughput, hence why they decided to go with Gen

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

eral Electric’s equipment. EMI invested too much in its technology and ignored what was happening in the s

.

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

urrounding environment. Competing in emerging markets is not about superior technology but rather about un

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

Companies that provide selfless information through particip

derstanding the customer’s need and evolving your product rapidly to match the changes in the market place

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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