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Did you know that an airplane in flight is off course nearly 98% of the time? No fli

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

ght is completed in a straight line from Point A to Point B. Gravity, side winds, up

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

Examples of combination products may in

rafts, and downdrafts are continually moving the plane off course. And yet, the majo

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

rity of flights arrive at their planned destinations safely and on time. How do airl

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

ne pilots make this happen? They continually keep the outcome or result in mind, say

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

Combination pro

departing from Los Angeles and arriving in Honolulu. Pilots constantly make correct

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

ons to compensate for outside forces affecting the plane and use a proven set of proc

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

ess steps to keep everything on course.

Closer to home, how can you, as the pilot of

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

your business assure that you are on time, within budget, and at the quality standard

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

s necessary 100% of the time? One important step is to focus on the outcomes you are

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

aiming for.

Whether it is a pilot flying a jet liner from LA to Honolulu or you stre

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

Following aspects would a

mlining a process in your business, focusing on outcomes will increase the odds of su

dd to the challenges in developing combination products:

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

ccess. Any time you are working to improve a process it is important to make sure th

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

t everyone involved in the process:

-- Shares the same goals of the process

-- Unde

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

rstands their individual role in the process (job procedures, etc.)

-- Has the perfo

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

mance support and skill/knowledge development required to perform their individual ro

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

Professional from academic institutions, pharmaceutical industries, health care indust

le

-- Understands what the gap is that is being closed (we are here, we want to get

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

here, here is how we will do it)

Just as the pilot constantly evaluates his/her cour

.

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

se corrections (wind speed, altitude, etc.) you will measure results of your improvem

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

Companies that provide selfless information through particip

nts and assess whether or not you are still on your course of performance improvement

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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Digg It - Focus on Outcomes to Keep Your Business On-Course

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