Main Subject - Business

Measure the right things. It’s not enough just to measure—you have to measu

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

re the right things.

A common measurement trap is to measure something because it’s

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

Examples of combination products may in

“interesting.” If knowing a measurement won’t change anything (e.g., help you make

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

a decision, verify an assumption or prove the problem is solved), then don’t waste y

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

our time measuring it.

Another common trap in defining the problem success criteria

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

Combination pro

is to lose the direct connection to the problem. Somehow it’s very easy to unintent

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

ionally expand the problem with general improvements that are good things to do, but

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

aren’t really necessary to solve the problem at hand.

Avoid these traps: once you

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

decide to measure something always check back by asking yourself exactly what you wi

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

ll do with the results. Then ask the question in reverse: if you have a particular r

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

esult, will it really enable you to make your decision, verify that assumption, etc.

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

Following aspects would a

With problem success criteria, cross-check your proposed measurements with your pr

dd to the challenges in developing combination products:

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

oblem description. Everything in the problem description should be measured by the s

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

uccess criteria. Everything in the success criteria should measure some aspect of th

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

e problem presented in the problem description. If they don’t match, your measuremen

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

ts are either incomplete, you’re measuring something unnecessary, or your problem de

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

Professional from academic institutions, pharmaceutical industries, health care indust

scription isn’t quite right.

HINT: “Everything necessary, nothing extraneous

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

” should be your watchword. Measuring the right things will help make sure you solve

.

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

the problem completely and don’t get sidetracked into doing other things that won’t

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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