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Businesses incur expenses towards achieving their goals, and the profit margin is influenced by va

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

rious factors such as operating and marketing costs. For instance, marketing costs are a major exp

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

Examples of combination products may in

ense in the beverage industry. Similarly, operating costs are higher in manufacturing firms such a

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

s chemicals.

Operating costs are driven by many factors such as raw materials and conversion and

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

maintenance costs. Raw materials are external to the organization, so there are little chances to

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

Combination pro

reduce the costs. But conversion and maintenance costs are purely internal, and depend upon the ef

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

ficiency of the organization. It is estimated that with good practices, maintenance costs can be b

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

ought down by 15 percent. Good practices can be preventive and predictive maintenance management s

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

ystems.

Industries that extensively use conveyor belts include the mining and process industries.

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

Conveyor belts are long, sometimes travel underground, and carry materials that may get stuck in

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

between the rollers. It is difficult to track the problem in case of breakage caused by materials

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

Following aspects would a

getting stuck. Maintenance issues include cleaning parts such as belts, rollers and pulleys, and s

dd to the challenges in developing combination products:

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

cheduled changes.

As materials get pinched in between the pulleys or on the surface of the belts,

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

cleaning the system is a prerequisite for good maintenance. Cleaning is needed at four stages. Th

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

first stage is at the drive pulley, below the flow of material. This is important when the materi

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

al is sticky. The next stage is called secondary cleaning, and the cleaners are placed behind the

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

Professional from academic institutions, pharmaceutical industries, health care indust

pulleys; they are either t-shaped or arm-shaped. Belt brushes and plough cleaners are used to scra

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

pe the material on their return paths. The material used for cleaning is either rubber or polyuret

.

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

hane, which is strong enough to scrape but at the same time doesn't wear on the belt.

The mainten

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

Companies that provide selfless information through particip

ance of the system also depends upon the strength of the belt and the type of material transported

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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