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If all other things such as project outlining, defining deviations and correction measures using the famed DMAIC, training the personnel, assessment and audit are

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

on one side, then the project selection on the other can outweigh all of them. It doesn’t matter that the improvement project is not more than academic interest; i

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

Examples of combination products may in

’s success depends entirely on the selection of the project itself.

What Does It Mean To Select a Wrong Project?

What does it mean to select a wrong project? Wel

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

, this question has arisen not because projects are selected wrongly by design or because the project selection teams are incompetent. This question can’t be misco

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

strued as something willful when especially it dawns at an advanced stage that the project is out of track and control and as a consequence, doomed to fail.

Fail-

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

Combination pro

roofing the Projection Process

In Six Sigma, project selection is based on two foundation cornerstones that are ‘total customer satisfaction’ and ‘maximization of

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

ROI.’ We can use the analogy that a home is only as good as its foundation.

Look for projects in your annual strategy documents that have roadmaps with various bu

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

siness objectives defined for the ensuing years.

Another place to look will be the budget and HR; HR, for one, is a major component of expenditures. Even though i

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

is not personnel reduction, along with the budget, it accounts for a major chunk of wastage adding to Cost of Poor Quality, COPQ. ROI maximization depends heavily

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

on reducing COPQ.

Customer survey, complaints received by sales department indicate the Voice of Customer or VOC. Complaints are opportunities which define how th

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

y benefit from your business services or products. Orienting business purposes towards VOC offers project ideas, too.

Places To Look For Projects

1. Recurring ev

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

Following aspects would a

nts like payroll processing, new hires, etc. consume resources endlessly. This category provides for result-oriented projects

2. Six Sigma projects get a boost to

dd to the challenges in developing combination products:

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

their success probability if the scope is narrowed down to realistic and quantifiable targets. The quote, “You can’t boil the whole ocean” applies here.

3. Define

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

the anticipated results and if they make measurable entities; measurable results are looked upon as practical and result oriented.

4. Select manageable projects a

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

s they can be successfully completed within reasonable timeframes. Projects of larger proportions take longer and resources eventually loose management commitment.

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

5. Brainstorming with key people from strategic areas generates ideas after critically examining rationalities of processes particular to their respective areas.

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

Professional from academic institutions, pharmaceutical industries, health care indust

rainstorming may critically examine the project selection process itself. Pay attention to cost drivers such as any wastages.

6. Process variation is another area

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

to look into. Are there hardened assumptions and notions about existing, variation prone processes can be disproved and whether there exists scope for streamlining

.

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

it? This is a major area you can expect the project to make substantial contributions to the bottom line by reduced COPQ.

Individual industry scenarios may differ

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

Companies that provide selfless information through particip

but these guidelines still hold. As project selection is the foundation, there is no sense in firefighting at a later stage, having gone deeper into implementation

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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Unfortunately, many buyers end up purchasing equipment that lacks the capability and flexibility to meet production volumes and tolerances, simply because they don't understand all available options and considerations. Between diminishing factory orders and increasing labor and energy costs, companies that use plate metal in their fabricating processes are finding their profit margins increasingly pinched.

Many industrial machines using compressed air as an energy source, use air cylinders or other pneumatic actuators to do the actual work....

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