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The above question ‘should six sigma metrics be different from other industry metrics’ arises from surprising sources. If you look at any quality management tool,

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

be it ISO, Lean Management Techniques or even cGMP (current Good Manufacturing Practice, the industry standard for pharmaceutical and healthcare product manufactur

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

Examples of combination products may in

ers), what meets the eye is the parity of all these tools. The foundation of any quality tool, in its simplest form, is total customer satisfaction.

Six Sigma Ver

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

us cGMP

No one can over emphasize the importance of adhering to quality manufacturing procedures when it comes to the manufacturing of sterile medicinal products

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

(medicines manufactured in sterile conditions for admission directly into the blood stream). The implication of this is that nothing short of the best is accepted

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

Combination pro

n terms of quality.

cGMP stresses standardization and compliance to processes verified through qualitative and analytical metrics. The analytical tools are scient

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

ifically evolved and are validated through market regulators which are also statutory bodies in their respective countries. Unlike Six Sigma, quantitative tools su

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

ch as the ones provided by statistics don’t find much application here. Even customer concerns are reflected by directives set by regulatory bodies.

If Six Sigma

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

s any different, it is only in how it deals with various aspects of doing business. It does not vary in the goal or end result. Fundamental metrics like DPMO spea

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

k to customer satisfaction levels. In the pharmaceutical industry, as opposed to other manufacturing industries, a totally different set of metrics is used. Produc

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

efficacies are measured by curative qualities, absence offside effects.

The Big Question

Should metrics be different for different industries? To a certain exte

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

Following aspects would a

nt, yes - in certain areas you can accept different metrics. As far as the minimizing of process variation is concerned, the goal should guide the tools. But havin

dd to the challenges in developing combination products:

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

g said that, is there still a need for different metrics?

Using The Wisdom; The Best Judge

As a wise man said, ‘the end result justifies the means’, it should no

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

bother anyone who wants to use a specific set tools for measuring certain process criteria. Six Sigma does not restrict the use of differing implementation proced

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

ures. As it is evolved specifically to each project with different criteria being used, measurement tools invariably vary within the framework of defined goals. Mo

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

eover, choosing a specific metric from among the available choices is an act akin to adopting an outside metric.

General Rules That Govern the Choice of Metrics

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

Professional from academic institutions, pharmaceutical industries, health care indust

Metrics are chosen specifically for each activity or processes based on various considerations. However, here are a set of general rules that applies to choice of

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

metrics.

1. Decision making processes critically depend on the choice of metric

2. Contribution to reduction in errors

3. Value addition through ability to cate

.

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

orize measurement for easy interpretation

4. Contribution of each individual and a set of metrics geared towards aligning customer requirements and management vis

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

Companies that provide selfless information through particip

ion with processes.

Is it the metric or the end result that you should be more concerned with? It is how you use a tool that is important rather than what you use

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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