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The knee-jerk response to prioritizing requirements is to mark everything as a must

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

-have . “I need everything before the product becomes generally available. I want i

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

Examples of combination products may in

t ALL!” Give me a break.

Granted, if a requirement is written in the SRS, then it

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

must be because you want it. But the reality is some features are more important th

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

n others and a good product manager can tell them apart.

If everything is high pri

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

Combination pro

ority, then there are no priorities. Let me repeat that statement once more. If

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

everything is high priority, then there are no priorities.

Unless this is your

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

very first software project, you know that time is always a constraint. Combine an

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

overly optimistic project schedule with a list of requirements that aren't prioriti

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

zed, and what do you get? A team of developers that implement what they want, when

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

hey want.

You have a choice. You can (a) leave it up to the development team to pi

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

Following aspects would a

ck and choose their favorite features to implement, or (b) give them a clear sense

dd to the challenges in developing combination products:

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

of direction by prioritizing the requirements. Have them start with the must-haves,

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

followed by the nice-to-haves. When the project deadline comes up, you can decide

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

o extend the project schedule to add a few more nice-to-haves, but you won't be for

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

ced to because your product will already include all of the must-have requirements

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

Professional from academic institutions, pharmaceutical industries, health care indust

that would make or break your sales. In other words, you're managing the schedule i

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

stead of letting the schedule manage you.

Wondering how to best prioritize requ

.

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

irements? Check out elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

gular/art20041208.htm">First Things First in The Project Mangler's archives.

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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