Advice You - Business

Every organization is looking for the holy grail of performance enhancement, that one thing that, if it were changed even slightly, would push the productivity of a company way beyond the current level.

Over the years t

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

here have been many solutions offered to the performance conundrum, from process improvement and process re-engineering to rightsizing and quality initiatives. All of which have had varying levels of success.

One area t

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

Examples of combination products may in

at is perhaps overlooked when organizations undertake productivity and process improvement programs and that is the behaviors of their employees. Often the only time behavior becomes a focus in an organization is when th

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

re is a problem employee that must be dealt with.

Studies have shown that there is a 5-fold difference in productivity between a top performer and a mid-tier performer. The top performer is 5 times as effective as his c

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

lleague who performs as the organization would expect.

This study has been undertaken by a number of organizations in varying ways and all with similar results. The skills and experience of the individuals are comparabl

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

Combination pro

and the processes and procedures are the same so what makes the difference? The main difference between the top performer and the capable performer are their behaviors both on and off the job.

A number of key behaviors

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

have been identified as desirable and can be seen within those who are peak performers in any organization and are the attributes that organizations on the whole try to recruit. However organizations often forget that ma

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

y behaviors are learnt and that existing employees, with the right encouragement, can adopt these behaviors as their own and in the process see their effectiveness rise.

The 5 key behaviors for peak performance are:

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

Pro-active - Looking for things to change and making change happen. Much is talked of pro-activity however often it is difficult for individuals to be truly proactive within an organization as change can be actively

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

iscouraged by management who believe 'they know best'.

Goal oriented - Set themselves targets to aim for. The key here is that they set themselves goals, often for just about every part of their lives. The peak p

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

rformer in business may well be a marathon runner outside, or be a keen learner setting themselves targets to accomplish within certain timescales.

Willing to fail - Are ready to take calculated risks. The top pe

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

Following aspects would a

formers in life are willing to try something even if there is a chance of it failing; often they see failure as a learning experience. Organizations who wish to improve their performance need to adopt a calculated risk p

dd to the challenges in developing combination products:

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

licy and follow the quote of Tom Watson 'If you want to increase your success rate, double your failure rate’.

Passion - Willing to stand up for what they believe in. The top performers will be passionate about t

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

e things in their lives, they may be passionate about sport, or their family or even about work. The important behavior is that they are willing to put everything else aside for their passion and have a total focus on wh

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

t is important to their passion.

Emotionally Mature - Not swayed by the emotion of the moment and able to think beyond a reactive approach. Often organizations make the assumption that the most vocal individual i

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

the one with the greatest ability; mainly this is due to the self promotion of the emotionally immature. This is recounted by the axiom 'promoted beyond their level of competence' where an individual is recognized not f

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

Professional from academic institutions, pharmaceutical industries, health care indust

r capability but for self-promotion.

Many people have one or two of these behaviors and often they are context specific. The major difference between the average performer and the peak performer with regards to these at

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

itudes is that the peak performer uses more of the behaviors in a work context.

The important thing to notice with all of these behaviors is that they can all be learned and therefore anyone can have them. And if anyone

.

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

can have them then anyone can be a top performer. Which means that any organization could improve their productivity dramatically without touching a single working practice.

Now that really could be the holy grail of pe

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

Companies that provide selfless information through particip

formance development.

More information regarding Organisational Change, Coaching and Performance Development can be found at http://www.achievinggreatness.co.uk

2005 © Achieving Greatness Ltd. All rights reserved.

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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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