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The foundation of Six Sigma is customer satisfaction and cost reduction by using various metrics and statistical tools. This is a customer-focused approach equipped with stra

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

tegies and discipline at all levels of administration, planning and production. Six Sigma is aimed at achieving only 3.4 defects per million opportunities.

Voice of the Cust

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

Examples of combination products may in

omer

Six Sigma places highest priority on customer data input which provides the much-needed insight into what the customers need and what he or she is thinking about the pr

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

ducts already on the market as a measure of performance. The design team needs to understand the requirements of the customer and predict whether the proposed (or the existin

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

g) design meets customer expectations.

How Is Customer Satisfaction Ensured?

All business activities are customer centric. Even the best product may not sell if it possesse

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

Combination pro

s useless value for the customers. A point in the case is the satellite phone Irridium© that Motorola developed some time ago. Although it was the first and the best in its c

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

ass, it failed in the market because the customer did not find any value in that particular product.

1. Customer’s Experience Of Defects and Costs: Customers have a differen

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

t perspective about quality and cost. The variation in satisfaction levels across different market segments and regions needs to be analyzed as a first step towards reaching

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

goals. In Six Sigma, customer input, however scattered it may be, when analyzed can be categorized making way for an in-depth understanding of company goals.

2. Product Rele

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

ance: The relevance of any product to the customer stems from its utility, cost and quality. A robust design is not just strong but simple, flexible and idiot-proof. It consi

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

stently produces a high level of performance despite huge variations in manufacturing and customer needs. Anything not adding value will not get customer attention.

3. Adjus

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

Following aspects would a

ting Process Capability to Customer Requirements: The need for adjusting the process capability is basically considered in DMAIC (a Six Sigma methodology for existing product

dd to the challenges in developing combination products:

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

), without putting significant burden on the cost. This begins with estimation of financial impact, feasibility studies of the technicalities involved and market uptake. The

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

outcome of these studies will guide any process adjustments.

4. Controlling Process Variations: The uncertainties of processing are the variation that needs to be tackled as

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

a critical step in achieving the 3.4 defect threshold. Uncertainties arise mainly due to a huge number of key elements in a process, outdated process steps and lack of contr

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

l. Variability surrounding a product or process can be rooted out at the design and analytical stages.

5. Removing Roadblocks: The roadblocks for Six Sigma implementation ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

n sometimes be within the organization, such as trans-jurisdictional roadblocks which sometimes threaten the effective implementation of Six Sigma. The Black Belts need Champ

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

ions’ intervention in removing these roadblocks.

6. Hitting the Finish line: Taking Six Sigma to its logical conclusion is no small matter, even for cash rich corporations.

.

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

he millions of dollars that it takes for Six Sigma implementation and the long cycle for the results to show can unsettle even the strongest organizations. Finishing the tas

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

Companies that provide selfless information through particip

k, despite allotment of huge funds, accessibility to knowledge base, depends primarily on the commitment level of senior leadership and a dedication to customer satisfaction

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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The surety bond market is currently a very conservative market. Contract and commercial bond departments throughout the nation have tightened up their underwriting practices due to enormous loses throughout the industry. Many sureties have had to close their doors, other have had their ratings drop to a level where they can not write the same business they could in years past. Obviously this leaves the bonding companies that are still operating with a very conservative outlook when it comes to their underwriting guidelines.

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