Main Subject - Business

As identity theft becomes a real problem in our society, paper shredders begin to fill a growing need in the community. Businesses and individuals both des

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

ire to safely and effectively destroy sensitive documents.

While individuals can rely on small paper shredders to effectively destroy credit card statemen

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

Examples of combination products may in

ts and bank paperwork, larger corporations need something more heavy duty.

Corporate paper shredders are often associated with hiding fraud or other illeg

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

al activities. Just think of all the shredder jokes that surrounded the Enron scandal. However, there is a legitimate need for quality paper shredders in t

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

he corporate world.

Just think about the amount of sensitive paperwork that passes through a credit union, psychologist’s office or accounting firm. Comme

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

Combination pro

rcial-grade paper shredders, as they are often called, are manufactured to destroy large amounts of paperwork in a minimum of time. They are built with lar

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

ge motors that can handle stacks of paper at a time, as opposed to personal shredders that can only take one or two sheets.

Selecting a commercial-grade p

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

aper shredder involves deciding on what features are most important to the company. Consider first how often the paper shredder will be used. Each shredder

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

will have a maximum running length and once that limit has been met, the machine will need to be turned off and allowed to rest for a specified period of

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

time.

For example, higher end shredders may be able to run for 10 to 15 minutes before needing a rest of 20 minutes. Smaller models may only be able to ha

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

ndle 3 minutes of continuous shredding before having to rest for 5 to 10 minutes.

Another feature that varies between shredders is the estimated shred vol

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

Following aspects would a

ume. This indicates the volume of paper that the shredder can handle. Analyze the shredding needs of the office and determine what paper capacity is necess

dd to the challenges in developing combination products:

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

ary.

Keep in mind that a shredder needs time to cool down between sessions and will break down if it is kept running continuously. To prevent this, consid

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

er purchasing a shredder that will be able to handle slightly more work than needed. This way the shredder won’t be running at maximum capacity all of the

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

time and the life of the machine will be increased.

There are two main ways that a shredder destroys paper. Strip-cut shredders cut paperwork into thin st

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

rips of ? of an inch or smaller. This option suits the security needs of most offices. Cross-cut shredders are more suitable for the most confidential docu

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

Professional from academic institutions, pharmaceutical industries, health care indust

ments. This type of shredder cuts both lengthwise and widthwise to create what looks like confetti, and these shredders are often referred to as “confetti

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

paper shredders.”

Commercial paper shredders need regular maintenance to run at their optimum rate. Lubricating oil must be applied to the shredder regula

.

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

rly to remove the build-up of paper dust inside the cutting apparatus. Most paper shredder manufacturers will recommend particular oil for their machine. T

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

Companies that provide selfless information through particip

he oil should be applied regularly depending on how often the machine is used. General repairs like paper jams can normally be handled by the office staff.

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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