Advice You - Business

Developing rapidly since the introduction of the first fully automated plain-paper photocopier b

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

y Xerox in 1959, present-day copiers work more like computers, combining copying, faxing, laser

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

Examples of combination products may in

printing, scanning and more into a single machine.

Although there are two types of copiers – an

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

alog and digital – the former is no match to the latter these days. In fact, most manufacturers

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

have stopped producing new analog models. To make matters worse for the analog models, the more

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

Combination pro

modern digital machines with similar features are now available at almost identical prices.

The

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

digital type enjoys a lot of advantages over its analog rival. Digital models combine copying,

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

network printing, and faxing. As there are fewer moving parts in the digital type, the instances

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

of mechanical breakdown are less. Less noisy, the digital copiers are more efficient in reprodu

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

cing fine lines and photographs.

Some people argue that analog copiers are more simple and user

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

-friendly. You have just one button to press to get a copy. But the digital copiers are not diff

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

Following aspects would a

icult to operate either. A minimal amount of training is sufficient for the employees to learn h

dd to the challenges in developing combination products:

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

ow to operate them.

Before purchasing a digital copier, you must have a clear idea of your requ

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

irements from the copier, as well as the volume of work the copier is expected to perform, and h

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

ow fast you want it to perform. You must also decide if you require a color copier or not. Altho

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

ugh color copiers are not as expensive as they used to be earlier, you will still need to pay 20

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

Professional from academic institutions, pharmaceutical industries, health care indust

% to 30% more than the cost of a black-and-white copier.

Today, there is a huge market for copi

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

ers, with the industry generating about $25 billion in revenue by selling over 1.5 million new c

.

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

opiers each year. Due to the presence of this large and competitive market, copier manufacturers

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

Companies that provide selfless information through particip

are now trying constantly to improve their products, leading to more benefits for the consumers

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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