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People often get confused when they hear someone say they are using Six Sigma. In fact, it is the methodology signified by DMAIC that they are referring to. Th

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

e very reason for their choosing DMAIC is that they have some existing processes which need to be ratified because they are bleeding resources heavily. On the

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

Examples of combination products may in

ther hand, DFSS, the acronym for Design for Six Sigma, dwells on R & D and design of products, processes with a view to minimizing process defects and variatio

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

ns at the root itself. At the onset, one must accept that the credentials of DFSS are not universally acknowledged, with most of the companies deploying DFSS f

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

llowing their own steps and standards.

Is DFSS A Stand Alone Methodology?

This question has arisen following many differences in the deployment methodologies

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

Combination pro

between Six Sigma, which is signified by DMAIC, and that of DFSS. However, DFSS can be called more as an approach owing to the fact that the version of impleme

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

ntation varies as the implementing team.

The actual application necessity of DFSS comes up when it is necessary to design or redesign a product from scratch.

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

nd since DFSS gets to the business from the beginning, the expectation from it is at a level commensurate with its reputation. Thus the expected process Sigma

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

evel is at least 4.5 for a DFSS service or product, but depending on the product, you can always go for higher or up to 6 Sigma level. Producing such a high qu

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

ality level with a markedly low defect level for service or product from ground up is not possible unless customer needs and expectations are completely unders

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

ood prior to designing and implementation.

Number Of Phases In DFSS Implementation

Of the several implementation procedures, as we discussed in the beginning

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

Following aspects would a

of this article, the one which found most followers is DMADV. The acronym DMADV stands for its five phases of implementation.

1. Define the goals of project a

dd to the challenges in developing combination products:

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

nd customer needs

2. Measure different aspects of customer specifications and demands

3. Analyze the options on hand for process to meet customer demands

4.

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

Design the process in detail to eliminate defect causing flaws

5. Verify the design by simulating performance and confirm if it meets customer specifications

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

Designing For Six Sigma

When we are starting from the beginning, unlike DMAIC, DFSS provides for building such process components which resist the defect caus

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

ing variations. Planning for DFSS calls for gathering all necessary information that sets off defect free products by error free productions and processes. By

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

Professional from academic institutions, pharmaceutical industries, health care indust

hese virtues DFSS can produce competitive results in financial benefits as would DMAIC have done or better like it had done in the implementations so far.

Imp

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

ementation Of DFSS

Unlike Six Sigma methodology, DFSS needs to be implemented from a very early stage for effective implementation. And the implementation str

.

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

ategy requires the crucial commitment and leadership, the training and planning to identify and establish measurable program goals and timeline and involvement

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

Companies that provide selfless information through particip

of all that concerned.

The fruits of Six Sigma are hard to measure as they are more of long time nature. But it is worth the wait considering the eventual ROI

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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