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The DMADV methodology can not be better explained than by comparing it with DMAIC methodology despite their fundamental differences. Take for ex

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

ample, the case of a traveling salesman who convinces a customer to buy at the best price. After invoicing and collecting the shipping details,

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

Examples of combination products may in

he discovers that there is a problem with the packaging department which is unable to reduce the shipping volume as desired by the customer. The

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

salesman now remembers that nowadays, more and more customers are demanding that their shipments volumes be reduced when packaged.

Now, the pa

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

kaging department has a problem on their hands which they are unable to resolve unless their rule books are rewritten. What should the project t

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

Combination pro

eam evaluate now; DMAIC or DMADV methodology?

What is DMADV Methodology?

The acronym DMADV sounds pretty much similar to DMAIC. The similarity

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

ends after the first three letters DMA.

1. Define: You will define the goals of the project and that of the customers (both internal and exter

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

nal)

2. Measure: Here you will quantify the customer needs as well as the goals of the management

3. Analyze: Analyze the options, existing pr

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

cess to determine the cause of error origination and evaluate corrective measures

4. Design: Design a new process or a corrective step to the e

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

xisting one to eliminate the error origination that meets the target specification

5. Verify: Verify, by simulation or otherwise, the performan

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

ce of thus developed design and its ability to meet the target needs

There is a new viewpoint in Six Sigma circles that DMADV is for designing

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

Following aspects would a

new products and services and that it may not be successful on existing business processes and products. Although the argument is valid to some

dd to the challenges in developing combination products:

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

xtent, you would do well to notice that the I of DMAIC is not far removed from the D of DMADV. You can easily say that design is an extended con

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

cept of improvement.

Difference Between DMADV And DMAIC

The difference, as one can see now, exists only in the way last two steps are handled.

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

In DMADV, instead of the Improve and Control steps which focuses on readjusting and controlling by one way or other, deals with redesigning the

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

process to fit customer needs.

Can You Use DMAIC In Place Of DMADV?

Lets simply put it the other way around. You can implement DMADV when you

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

Professional from academic institutions, pharmaceutical industries, health care indust

do not have an existing product, which you are aiming to create from scratch. The second occasion when you can think of using DMADV is when in a

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

ctual practice, DMAIC has not yielded the result you were looking for despite best efforts to make improvements. In a nutshell, the latter reaso

.

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

n can be summarized as: use DMADV when process improvement either fails or does not deliver to your expectations.

There are occasions when plan

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

Companies that provide selfless information through particip

ned DMAIC has turned into DMADV ultimately. Black Belts must take credit for this, in my view, as this reflects their in-depth subject knowledge

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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