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No matter what, your business will benefit from Six Sigma certification; unless, of course, some unforseen situation happens to disrupt the implementa

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

tion of the Six Sigma methodology; not the least of which is inadequate Six Sigma training.

Six Sigma Certification - Will It Really Benefit Your Org

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

Examples of combination products may in

nization?

The success of Six Sigma certification and implementation depends on many factors. It requires nothing less than a relentless effort and de

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

ication to see that it succeeds. Although specific procedures may be in place, an equal responsibility lies on upper management to dedicate their 100%

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

of their time and resources to this mammoth task. The top and bottom ends of your business, and all those in between, need to come together with singl

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

Combination pro

minded contributions to make Six Sigma certification and implementation successful.

Six Sigma Certification Benefits To Your Business – An Overview

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

You need to realize that, before the real implementation begins with Six Sigma methodology, the groundwork needs to be laid. Depending on the size and

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

culture of your business, your team needs to have a brainstorming session, with key focus on potential benefits and consequences of having your employ

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

es attain Six Sigma certification. As the employer, you need to sponsor your employees in their Six Sigma training efforts. The decision to go for Six

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

Sigma certification is nothing less than a dollars and cents decision.

Benefits To Your Business

Six Sigma certification benefits are both tangible

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

nd intangible. Intangible benefits can be in the form of customer loyalty that will follow the life of your business. Below we examine some of the ben

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

Following aspects would a

efits of Six Sigma certification.

1. Increase In Your Bottom Line: Six Sigma certification results in improved processes, better utilization of resou

dd to the challenges in developing combination products:

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

ces like finances, time and materials and reduction in the cost of production. On the customer side, there is higher satisfaction with products/servic

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

s. This improves your bottom line substantially.

2. Six Sigma Certification Increases Shareholder Value: Fundamentally, this results from increased r

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

venues, but in addition to this, there is increased customer loyalty and confidence that raises the stock values as well as the value to shareholders

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

to whom you are responsible).

3. Total Customer Satisfaction: Customers get more than what they asked for on the product/service side, at a lower pri

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

Professional from academic institutions, pharmaceutical industries, health care indust

e or higher value.

4. Decreased Employee Attrition: Six Sigma training boosts employee morale due to a reduced workload. Six Sigma certified employe

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

s realize the positive returns of quality work, which keeps them motivated. This reduces employee turnover and burnout.

5. Six Sigma Certification C

.

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

eates A Win-Win Situation For The Supply Chain: In converting supplier-customer relationships to long-term partnerships, both parties win. Six Sigma t

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

Companies that provide selfless information through particip

aining and certification accelerates this process with its focus on quality; prices come down and both the product quality and life cycle time improve

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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