Useful Advices - Business

Hook-loop fasteners are a two-faced fastening system whereby one face is covered in tiny

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

nylon fibers with little hooks on the ends of them, and the other face is covered in ti

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

Examples of combination products may in

ny nylon loops. When the two faces are pressed together, some of the hooks burrow in and

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

catch onto the loops. The tighter the two faces are pressed together, the more catches

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

that are formed. This forms a powerful bonding system that can support great amounts of

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

Combination pro

eight. You can’t pull the faces of the hook-loop fastener directly apart; rather, you mu

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

st pull a few hooks and fibers apart from the one of the edges of the two-face bond. Whe

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

n you continue pulling, the hooks and fibers “un-catch” a few at a time, making a “rippi

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

ng” sound, and the hook-loop fastener is freed.

If you said, “Hey, that sounds a little

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

bit like Velcro!” you’d be closer to the truth than you know. That’s because it is Velc

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

o. Velcro is a brand name – the first brand of hook-loop fastener ever. It was created b

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

Following aspects would a

y Swiss inventor George de Mestral in 1948; de Mestral received patents for it from all

dd to the challenges in developing combination products:

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

over the world throughout the 1950s. The name Velcro comes from adjoining two French wor

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

ds: velour (velvet) and crochet (hook).

Today, hook-loop fasteners are a still very wid

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

ely used in shoes, clothing, cars, and more. Among the benefits of hook-loop fasteners a

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

e ease of attachment, strength of bond, ease of unfastening, and low cost of manufacture

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

Professional from academic institutions, pharmaceutical industries, health care indust

. One way in which product developers increase the strength of hook-loop fasteners is to

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

connect the two faces at one end and thread one face through a flat pulley, such as a m

.

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

etal grommet in a shoe. The faces are pressed together as usual, but the pulley principl

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

Companies that provide selfless information through particip

e increases the number of hook-loop bonds, thus maximizing the potential of the fastener

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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Useful Advices - The Advantages of Hook Loop Fasteners

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