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As with any goal or activity to get any percentage chance of success, you need

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

to know what success is.

What are you aiming for? What is the purpose of beg

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

Examples of combination products may in

inning the activity? The same applies with projects.

A project, be it a mult

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

i-million dollar construction development, or a scrapbook, needs to have an en

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

point - that particular final event which marks completion. Whatever the scop

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

Combination pro

e the end point needs to be identified before the project begins. It could be

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

domestic, a new kitchen installed, decorated and working; paint a bedroom; in

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

tall a water heater etc. It could be industrial, install and commission a piec

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

e of machinery; implement a safety management system; design and build an acco

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

unting package etc. Or it could be personal, run a marathon; drop 2 clothes si

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

es, walk the Kokoda Trail; climb Everest etc.

Each project is different and e

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

Following aspects would a

ach has a unique defined end point. To be successful in managing a project, yo

dd to the challenges in developing combination products:

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

u need to define (or have defined for you) that end point. So begin with the e

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

nd in mind.

Similarly to goal setting; the end point can be more easily defin

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

d using SMART as an acronym.

Specifically stated - Stated positively in prese

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

nt tense Measurable - What will I see, hear, smell, taste, feel and touch upo

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

Professional from academic institutions, pharmaceutical industries, health care indust

n completion Achievable - Can I achieve it by myself, what input do I need fr

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

m others? Resources - What resources do I need? Time based and Towards - Wh

.

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

en precisely will this outcome happen?

Whilst it’s possible to hit an invisib

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

Companies that provide selfless information through particip

le target, it is much easier to plan and to hit a visible one. So get defining

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 - Project Management - Begin With the End in Mind

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