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Six Sigma projects are not immune from a failure. Just like any other business improvement initiative there are projects that don’t succeed. When projects aren

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

’t successful, it is not the fault of the system itself but rather it is to do with the implementation and application of the system. Let’s face it, if the syst

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

Examples of combination products may in

m itself was inadequate there would not be so many success stories.

Many people perceive a project as unsuccessful when it fails to meet the targeted savings.

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 is a view that needs to be questioned and may best be done by way of the example below.

A common metric for projects is ROI, Return on Investment. One mig

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

t question whether not reaching a particular ROI number is a strictly a failure. For instance if the target ROI is 15% and the project ends up delivering a ROI

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

Combination pro

of 10-12% would you really call it a failure? That’s a matter for individual organisations to decide. Personally, I think that having a return of this magnitude

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

can still be considered successful. It’s just not quite as successful as initially hoped.

Further, I have recently heard of a manufacturing changeover project

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

that was targeting a mold change of under a minute in an injection machine. The actual changeover time at the end of the project was 9 minutes. Was this a failu

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

e? To answer this question one would need to know what the baseline was. Prior to the improvement project the changeover time was over 60 minutes. Either way, t

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

his improvement is significant. An actual reduction in changeover time of 85% is still an excellent result.

So rather than be concerned about failure one shoul

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

be concerned with making projects more successful and how better to meet the desired outcomes.

Some of the common reasons that Six Sigma implementations don’t

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

Following aspects would a

always deliver the results are:-

Overly optimistic targets
Demanding too short payback periods
Inadequately defined projects
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
Projects not aligned to company objectives
Not embracing the Six Sigma mindset
Viewing it as a mathematical exercise
Lack of

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

commitment from Champions

Training the wrong people

Isolated and sporadic projects

Lack of an “umbrella” project coordinating act

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

vities and resources

Applying the wrong tools for the task at hand

Providing insufficient time for staff to dedicate to project tasks

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

Lack of an experienced mentor for new practitioners

As we can see, the range of factors for organisations not achieving their desired outcomes

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

Professional from academic institutions, pharmaceutical industries, health care indust

rom Six Sigma projects are quite varied. What should be obvious is that none of these things are particularly difficult to resolve with the right help. Six Sigm

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

a training provides people with the skills and knowledge to apply the tools but the real benefits come from correctly applying the methodology and philosophy to

.

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

meet business objectives. This skill comes from practice and takes time to develop.

Organisations who are new to Six Sigma should seek help and guidance from e

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

Companies that provide selfless information through particip

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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