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Project Failures and Project Success

Some organizations and project managers tend to resort to simplistic view when it comes time to judge if the

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

projects they are assigned to manage is a success. The tendency is more due to the most popular success criteria to measure the success from just

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

Examples of combination products may in

the triple constraints of CTR or cost, time, and resource performance points of view.

In my view, there are really a lot of other success criter

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

ia or parameters on top of the triple constraints to measure success of a project and it has to be viewed from different stakeholders’ point of vi

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

w.

Project is considered a Success when one is completed ahead of schedule or on time, within budget, which has been executed safely and has met

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

Combination pro

or exceeded the many project performance parameters in technical, safety, quality, plant capacity, features, product specification, and in commerc

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

ial sense or parameters from major stakeholders; and where the client is happy with what he has been given to the extent one can expect repeat ord

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

r from the client; and other stakeholders share the success to the extent the project team is looking forward to working together as a team in an

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

upcoming project.

I know and sort of agree if you think this is a mouthful, and in fact it is; but it also reflects a project success in a comple

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

te sense.

As we can see from above project success definition, it is perhaps easier to identify projects, which are generally recognized as unsuc

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

essful, if we are to identify where things have gone wrong, and hence what has to be done and how to prevent them to insure project success.

To m

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

Following aspects would a

y personal experience and some research that I have had opportunity to work on, project failures are primarily caused by one or more of the follow

dd to the challenges in developing combination products:

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

ing:

 SCHEDULE OVERRUN
 MONATORY OVERRUN
 RESOURCE AND SKILLS UNAVAILABILITY
 CHANGING REQUIRE

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

MENTS
 POOR SCOPE OF WORK DEFINITION & SPECIFICATIONS CHANGES
 UNDERPERFORM ENVIRONMENTAL PARAMETERS
 REGUL

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

TORY NON COMPLIANCE
 UNREALISTIC CUSTOMER’S EXPECTATIONS
 NO FUNCTIONAL INPUTS AT PLANNING STAGE
 RESOURCE

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 OVER COMMITTED OR STRETCHED TOO THIN,
 WRONG PERSON AS PROJECT MANAGER
 NO ONE IS RESPONSIBLE FOR TOTAL PROJECT

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

Professional from academic institutions, pharmaceutical industries, health care indust

 NO PROJECT ACCOUNTABILITY
 NO SYSTEMS IN PLACE; NONE ADOPTED

In most cases the root causes of project failures have been

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

ttributed to one or more of the following:

1. Poor resource planning and management
2. Poor project communication management
3. Poor pr

.

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

oject management and leadership issues
4. Poor scope of work definition and specifications
5. Poor cost estimating and control
6. P

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

Companies that provide selfless information through particip

oor time/schedule planning and control

And believe or not, failures in any projects are most likely caused by people issues than technical issues

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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