Advice You - Business

The most easily expectable reaction from employees for Six Sigma implementation will be the one of Well, here they are at it again or How good is it over other e

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

xisting methods? Knee jerk reactions, such as these are nothing new in an industrial world. Cold responses such as these can dampen the zeal of Black Belts initi

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

Examples of combination products may in

ally, if not completely unnerve them. Why should the culture be so different and how to adopt Six Sigma in these circumstances are some of the big questions that

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

confront the project team.

Cultural Issues - Six Sigma Adoption and Acceptance

Most of the times it is the skepticism that manifests as different issues oppos

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

ed to the adoption of Six Sigma. Surprisingly enough, skepticism is not just limited to employees alone. Let us say a saving of $250,000 per project seems unreal

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

Combination pro

when you really look at it. Further, it becomes even harder to believe when advertised a higher cumulative amount over long periods of time and several projects

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

. Accrued savings could run into a couple of billions of dollars in a decade’s time.

On the other hand, management is not always open to accepting the migration

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

to Six Sigma from another regimen. Questions may arise, such as Does it apply to us? It might have produced results elsewhere but this is a unique situation. Th

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

e question remains same even if the product or process is same as that of competitors. This roadblock predominantly exists because of the wrong conviction that t

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

hey are somehow different from peers and that it will not work for them.

Take another one for example. Six Sigma takes fulltime Black Belts which we can hardly

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

afford at the present moment, at the cost of our day-to-day activities. It also requires several others to dedicate some of their time to the project.

Strategiz

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

Following aspects would a

ing Six Sigma Implementation

First of all, it is essential that management has an open mind. Six Sigma is applicable across the board, regardless of the size an

dd to the challenges in developing combination products:

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

d line of business of the companies. Also realizing the need for it, much later when the market and the top and bottom lines have eroded, will be of little help.

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

1. The Proof Of Pudding Is In Eating It: Success stories of Six Sigma will have no impact as much as the actual success you could show now. The milestones for

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

impressive results are financial uptrends, better employee satisfaction, and finally the satisfied customer. Measured by the conventionally perceptible barometer

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 more visibly acceptable changes satisfy the skeptics.

2. Reviewing The Work Culture At The Beginning: There is no better way than assessing the cultural w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ays of a company and employees work culture while you are still putting together the project and the team. The support from top down, infrastructure and the cont

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

ext of time will help shape things up for deployment of Six Sigma.

3. Familiarity And Positive Developments Bring About Positive Changes: As things get familiar

.

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

to people, they tend to see reason and accept spending resources. This basically stems from their realization of returns from the deployment.

Maintaining an en

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

Companies that provide selfless information through particip

vironment conducive throughout the deployment is crucial for its success. The transformation it brings in can be far more rewarding than financial benefits alone

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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