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Talking to owners of small businesses about Six Sigma, one can almost hear them thinking that this is too expensive for them and is something that only applies to the very well

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

known big businesses like Motorola, GE, Sony, Dow Chemicals etc. It is only when they hear about the philosophy that underpins Six Sigma that they start to get an idea that it 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 an improvement methodology that works for organisations of all sizes.

The target of Six Sigma is to reduce variation. This reduction in variation provides for a far more cert

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

ain process, resulting in less waste and more reliability which ultimately improves profit. For many years people have thought waste is a natural part of any process, now this b

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

sic tenet is in question. Why should a certain level of waste be accepted as a natural part of the process?

It is easy to understand why people are at first somewhat confused a

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

Combination pro

bout Six Sigma. Many associate the methodology with high level statistical modeling. Although it is true that some of the tools are statistical there are certainly others that a

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

re not. Great benefits can be achieved through the use of some of the other tools such as Pareto Chart analysis, Fishbone Diagrams and Process Mapping. To the uninitiated these

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

tools sound complex but once demonstrated, people are surprised how powerful and intuitive these techniques are.

One of the key facets of the Six Sigma process is the logical w

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

y that it goes about problem solving. The DMAIC model (Define, Measure, Analyse, Improve and Control) provides a structure that leads practitioners through a thorough and rigoro

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

us process that focuses efforts on the things that really matter. Of course with Six Sigma, as with many other processes, it can be easy to spend a lot of money on very little g

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

ain. Conversely, excellent savings can be made by organisations that implement wisely. The difference between success and failure is in having people who know which tool to use

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

Following aspects would a

for the particular job at hand. This is no different in having a tradesman being able to select the right tool for the job or a surgeon knowing which way to tackle a complex med

dd to the challenges in developing combination products:

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

cal problem.

Training of Six Sigma practitioners can be an expensive exercise and this is what causes some small business owners to avoid adopting it. Owners of small businesse

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

s typically can’t afford the extensive time it takes for training as well as the training cost. Additionally, developing good skills takes time. Time is something of which owner

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

s of smaller business have precious little. The great news is that they don’t have to! Outsourcing is a very cost effective option. Use the resources of a trained Six Sigma Blac

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

k Belt who can assist with all of the phases of initiating an improvement project. This is the best of both worlds because the business owner can get moving quickly on an improv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ment project while still being focused on daily activities. Small business owners already have enough to do so it makes sense to seek out expert help just as they would an accou

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

ntant or a lawyer.

Organisations can find that it is cost effective to bring in a skilled Six Sigma practitioner to lead and assist an initial project. In this way an organisat

.

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

ion is able to develop a Six Sigma mindset which will become part of the organisation’s character and continuous improvement will become a self perpetuating activity. Once peopl

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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