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The Six Sigma approach comprises a management initiative, improvement projects and a set of methods and tools. Six Sigma is about a breakthrough in business improvement. Compani

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

es trying to implement the program find considerable difficulty in getting commitment from various functions. This happens despite the project teams being able to identify signi

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

Examples of combination products may in

ficant operating efficiencies. The main reason for this is the impact on the company’s bottom line not being clearly discernible. The Six Sigma program can be implemented much m

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

re effectively if the CFO and his/her staff can be brought on board so that their concurrence can be obtained.

The Six Sigma Program: The Six Sigma strategy aims at achieving

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

breakthrough business improvements and then creating the required infrastructure and systems to grow and maintain the gains. Typically, Six Sigma projects target a 30% to 60% pr

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

Combination pro

cess improvement in 4 – 6 months. The overall aim is that the Six Sigma mindset should spread throughout the organization. Employees become aware of the ramifications of poor pe

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

rformance, unproductive processes and non-value adding activities. It is essential that the improvements be linked to the bottom line. In fact, many organizations stipulate that

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

the finance department verifies the financial spin-offs, and where exactly in the financial statement this will manifest itself. A project tracking software is employed, that me

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

asures the process improvements and the financial spin-offs and generates the reports. Considering the importance of the impact on the bottom-line, the finance function has to c

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

osely associate with the initiative from the outset.

Co-opting the Finance Function The success of the Six Sigma program depends largely on selecting and training the right pe

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

ople to fill key roles. Good companies allocate potential leaders on a high career growth path to fill key project positions. The detailed composition of the team is always a ma

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

Following aspects would a

tter of debate. The team must have cross-functional representation to tackle various issues that may arise. Finance and accounting executives have a particularly important role

dd to the challenges in developing combination products:

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

s they act like scorekeepers and report on key business parameters affecting the bottom-line. This results in creating greater shareholder value, which in turn ensures the succe

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

ss of the Six Sigma initiative. The finance professional must be co-opted at the inception of the project to contribute the maximum value to the team. He can, also help in desig

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

ing an appropriate incentive system for rewarding performance by team members in tandem with human resources.

Quality Issues: Quality in businesses encompasses the entire proc

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

ess and focuses on eliminating defects and producing goods and services that satisfy the customer. The Six Sigma process incorporates the financial aspects at all stages of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

roject:
• Before starting a project, a financial impact analysis is carried out to identify benefits.
• During the project, the employees and management become aware o

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

f the actual processes of the business in various aspects, and how they are performing, including financials.
• After the project or during completion, a review of actual

.

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

esults is done and the returns quantified. This serves as a feedback for the Quality department.

Any quality program, including the Six Sigma initiative, can be much more e

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

Companies that provide selfless information through particip

ffective if the project is tied to quantifiable financial results. Informed and motivated employees, with good training can make all the difference to the success of the program

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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