Digg It - Business

These days, the struggle to survive is becoming increasingly intense for businesses of all sizes. Special strategies need to be adopted

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

in order to improve the functioning of a company in order to allow it to keep up with the intensity of today’s marketplace. For this rea

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

Examples of combination products may in

son, many businesses have chosen to seek the advice of experts who can better the overall functioning of their organizations to ensure th

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

at they are reaching their highest potentials.

Among the strategies being recently and successfully implemented is the DMAIC Model, whic

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

h stands for Define-Measure-Analyze-Improve-Control. Experts, including Six Sigma Black Belts, swear by this model for overall business

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

Combination pro

success though quality control, problem management, and common sense. It works as follows:

• Define – this refers to defining the goals

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

of any given improvement effort. Top level improvement goals may include strategic efforts such as increasing the ROI or market share.

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

Closer to the operations level, an organization’s goal may involve bettering the output of a given department. On the projects level, th

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

e goals may involve decreasing defects and increasing production. Data mining methods are applied here for identifying prospective oppor

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

tunities for enhancement.

• Measure – this refers to measuring the current process. Reliable and valid metrics need to be established s

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

o that the different steps towards achieving the goal can be defined. This starts with the definition of the current baseline. Explorat

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

Following aspects would a

ory and descriptive data analysis are applied here for assisting with the understanding of the data.

• Analyze – this refers to the anal

dd to the challenges in developing combination products:

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

ysis of the system in order to recognize the disparity between the current system performance and the goal. Statistical tools are applie

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

d here for guiding the analysis.

• Improve – this refers to the improvements made to the system. Creativity must be employed in order t

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

o discover fresh ways of doing things cheaper, faster, and better. Project management and other management and planning tools are used he

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

re in order to facilitate the implementation of the new methodology. Statistical methods are also used in order to validate improvements

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

Professional from academic institutions, pharmaceutical industries, health care indust

that have been made.

• Control – this refers to controlling the new system. The enhanced system must be institutionalized through the

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

modification of compensation and incentive programs, policies, MRP, procedures, operating instructions, budgets, and other systems of man

.

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

agement. You can choose to use such systems as ISO 9000 in order to ensure accuracy of the documentation.

Though the DMAIC model does i

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

Companies that provide selfless information through particip

nvolve a reworking of the mindset of a business, strategies such as Six Sigma have seen tremendous, dynamic results upon its application.

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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