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For those organizations that are constantly engaged in innovating their products or services, DFSS, an acronym for Design for Six Sigma, is not new. But 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

general statement by many that they are implementing Six Sigma shows that they are a little bit confused - in most cases one will be using DMAIC, which is ap

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

Examples of combination products may in

licable in cases where there are products and services that already exist.

DFSS is more focused on innovating and designing new products or redesigning them

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

to suit the business. The designing exercise can be started from scratch, as it has happened in many cases. Thus, DFSS is implemented for design of new prod

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

cts.

DFSS Is Closer To DMADV

In actual practice, DFSS hardly differs from DMADV, an acronym which stands for Define, Measure, Analyze, Design and Verify. I

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

Combination pro

is this design factor which makes all the difference between DFSS and DMAIC. The designing or redesigning a process or a product arises by following the Def

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

ine and Measure steps. You will notice that these are the same initial steps in DMAIC implementation. Even the analysis stage, going by the name, is somewhat

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

similar.

Many experts acknowledge the difference in the analysis stage, even though the name suggests similarity. Analysis in DFSS has its intention focused

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

on critically looking at vacuums that beckon new services or products from scratch or improving upon something. Whether the deployment proceeds to design sta

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

ge depends on the outcome of pragmatic analysis.

Six Sigma practitioners hardly disagree that the suggestion of creating something from the ground up requir

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

s nothing less than a critical review of the need for the proposed product. The basis for such an analysis is the Voice of Customer and business objectives a

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

Following aspects would a

defined in the first stage. This argument should also explain the objectives of choosing DMADV or DFSS.

How Does DMAIC Fare In The Wider View Of Things?

S

dd to the challenges in developing combination products:

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

ix Sigma DMAIC, as everyone knows, encompasses every aspect of doing business. DMAIC emphasizes Defining, Measuring and Analyzing variations in processes alr

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

ady in place. The use of the right tools after defining each process for measuring critical parameters throws up deviations which otherwise would have contin

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

ed to exist. All too clearly, the central force of DMAIC is applied at removing process errors and eliminating wastage, which consumes resources to unmanagea

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

ble proportions. (This underlines the big savings achieved by GE, Motorola, Honeywell and many others over the years.)

DFSS has many variants which are prac

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

Professional from academic institutions, pharmaceutical industries, health care indust

ically being used by various industries. The reason for this variance is not all too difficult to comprehend, as the methodology is not still universally ack

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

owledged so as to be standardized. Each one of the trainers might teach the concept differently which goes on to manifest as different implementation styles.

.

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

DCCDI, DMEDI and IDOV are the three significant methodologies now predominately in practice. DCCDI is an acronym for Define, Customer, Concept, Design and

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

Companies that provide selfless information through particip

mplementation while DMEDI stands for Define, Measure, Explore, Develop and Implement. And finally the IDOV stands for Identify, Design, Optimize and Validate

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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