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Look for sponsors and solution owners rather than problem owners.

Everyone par

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

ticipating in the situation owns the problem, like it or not—and nobody likes it. Howe

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

Examples of combination products may in

ver, if one person is designated as the problem owner, that gives everyone else involv

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

ed implicit permission to step away and essentially pretend that they don’t have an ow

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

nership role in the problem. In other words, appointing a problem owner gets in the wa

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

Combination pro

y of solving a problem.

A much better term for what is usually expected of the “probl

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

em owner” is “sponsor.” A sponsor is the person who champions the problem-solving proj

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

ect by assuring awareness of the importance of the project, allocating resources, remo

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

ving obstacles, etc. The words are important. Having a sponsor gets support for the pr

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

oblem-solving project without removing (or appearing to remove) responsibility for sol

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

ving it.

Another difficulty with the term “problem owner” is that it has a blame conn

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

Following aspects would a

otation. A typical corollary to discussing who owns the problem is discussing whose fa

dd to the challenges in developing combination products:

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

ult it is. This is totally counterproductive to solving the problem. People get angry,

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

and these discussions often deteriorate into finger-pointing rather than focusing on

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

the root causes of the problem and what can be done to address them. “Solution owners”

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

are people who are in a position to do something constructive about eliminating root

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

Professional from academic institutions, pharmaceutical industries, health care indust

causes of the problem. Helping with a solution is much more fun than being blamed for

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

a problem, so you’re more likely to get the response you need.

The terms you use are

.

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

important. Avoid the not-my-problem trap by getting sponsors. Avoid the finger-pointin

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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