Main Subject - Business

Utilizing The Skills Of Black Belts

Most people believe that Six Sigma is for large organizations and is not cost effective for small busines

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

ses. However, this is just a misconception because Six Sigma concepts and methodologies can be tweaked to make them deployable in small busine

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

Examples of combination products may in

ss organizations as well. Deploying Six Sigma in small businesses has been made possible with the development of new tools and techniques that

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

can be altered to suit all types of processes, be it a simple process involving just two to three steps or a complex process having numerous

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

sub-processes.

Small businesses just need to hire the services of Six Sigma professionals such as Black Belts who have the requisite qualific

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

Combination pro

tion, skills and experience to handle Six Sigma implementation projects. Small businesses that do not have the requisite funds to pay for the

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

services can opt for providing Black Belt training to existing employees. This is often more beneficial for small businesses because once the

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

employees are trained, the organization will never have to pay for the services of Six Sigma professionals hired from the outside.

How Black

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

Belts Are Effective

Black Belts can implement Six Sigma concepts and methodologies in all types of small businesses, be it a manufacturing un

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

it or a services company. During the initial phase of any Six Sigma implementation program, the belts assess existing quality levels, which ma

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

be 1 sigma, 2 sigma, 3 sigma or 4 sigma. The aim is to make consistent improvements in quality until Six Sigma quality levels are achieved. I

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

Following aspects would a

n small businesses, the savings derived through Six Sigma implementations may not match the multi-million dollars savings generated in large o

dd to the challenges in developing combination products:

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

rganizations, but are certainly enough to make the small business more competitive in the marketplace.

Additionally, quality improvements hel

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

p small businesses to offer cost-effective products or services to their customers, which ultimately leads to increased customer satisfaction.

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

It helps them to develop customer loyalty and increase customer base, both of which are necessary for the long-term success of any business o

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

ganization. It also provides a level playing field to small businesses, allowing them to compete with large business organizations that might

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

Professional from academic institutions, pharmaceutical industries, health care indust

be offering similar products or services.

Six Sigma implementations do help in increasing the efficiency of existing business processes, but

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

before implementing the various concepts and methodologies, small organizations need to assess the monetary value of derivable benefits and co

.

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

mpare it with the implementation costs. Implementations should be undertaken only when the benefits outweigh the implementation costs. Small b

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

Companies that provide selfless information through particip

usinesses that follow this procedure are most likely to succeed in their Six Sigma initiatives and maintain competitiveness in the marketplace

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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Learn from how NASA set the Space Program goals. Use this knowledge to build a sustainable business and maintain a healthy lifestyle.

Have you ever stopped and thought about why you got into business? What was the driving force behind your decision to lose the security blanket of having a regular paycheck, benefits and regular vacations? Do you lay awake at night, worried about how you are going to feed your family, the unresolved client issues, or just the stress of an employee upsetting one of your best clients? These are some of the questions entrepreneurs ask themselves on a regular basis when trying to figure out why they ever got into business for themselves.

You think of yourself as a good businessman. But how good a client are you? How do you behave as a customer to others? Failure to do it right can kill your business...

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