Advice You - Business

It is curious how the use of something can change over time. Like the tailbone or the appendix, many things have survived from the past that have lost all reasons to survive. Yet they do survive, cl

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

ueless dinosaurs from a previous age that have adapted themselves to newer uses, becoming a croc or a lizard in the process. The lanyard, that curious piece of string that pops up in all places and

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

Examples of combination products may in

omes attached with all sorts of things, is one such remnant of a previous age.

It is uncertain as to when the first lanyard came up. And for what purpose. Being basically a piece of string it could

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

have found some useful business in a previous day. Nor can it be said with any conviction that its primary and first use were defined in the army camps of pre-modern Europe. Chances are variants of

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

lanyard were used in other lands for other purposes – for hanging sword, or a jacket, or tugging at the beard of a hard taskmaster. However, firm claims as the inventor of this ubiquitous piece of s

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

Combination pro

tring comes from the army and the navy only. The lanyard was originally a long piece of cord – around one meter in length – that was used to secure the jack-knife or the sword. The tradition develop

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

d of wearing the lanyard on the left shoulder attached to a jack-knife which was tucked into the left breast-pocket. The color and the position (left shoulder or right) have changed from this to tha

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

t but the lanyard has maintained its ornamental position on the breasts of military men for the last many centuries – from tin-pot dictators in the interiors of Africa to stocky four-star Generals i

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

US Army, from pretentious royal princes in funny dresses to fake presidents in Amazon jungles. Other sources maintain that the lanyard was first used to tie the fodder for the horses pulling the ca

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

nnons. Later, its use deviated to pulling the fire-trigger on the artillery, a use that continues to this day in some older systems. With its expertise with ropes and knots, the navy says the lanyar

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

was its invention. Curiously, in the navy too it ended up at the same place – a sort of collar for the shoulder for the men in uniform. Various uses of the lanyard were devised within the camps. So

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

Following aspects would a

e used it to tie their sabers to their wrists allowing them to fire the pistol with the same hand – the word dragoon, French in origin, derives from this usage. Later on when pistols became standard

dd to the challenges in developing combination products:

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

issue, the pistol was attached to the uniform with the lanyard. Everywhere we find that the lanyard stayed close to the main object of the profession of the men in uniform.

Times have changed. The

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

adage that sounded hollow a few years back – that the pen is mightier than the sword – has fought back in favor of the wielder of intellectual resources. Today, the lanyard is seen more in the compa

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

ny of civilians than in the company of the men in uniform. The lanyard comes attached to the pen, the torch, the knife, the badge, the whistle and what not. As consumer gadgets get more miniaturized

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

everything from cell phones to iPods and digicams gain the hallowed company of the lanyard. It is a sign of the changing times that the most empowering devices (phones and cameras) are now associat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed with something that was similarly the companion of symbols of empowerment yesterday (swords and guns).

Not to be left behind, the metaphor of empowerment is sought by charitable causes. MakePove

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

tyHistory, the international campaign to end extreme poverty around the world, has chosen the humble lanyard as a symbol of sympathy with the just cause of liberation from oppression. As the officia

.

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

l website itself adds: “By supporting Make Poverty History we can prove our role as liberators but not in a way that is painful and boring but exciting and new!”. The lanyard can hold the keys to li

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

Companies that provide selfless information through particip

eration and it also doubles as a mobile phone holder!. There you have it – empowerment from the humblest of sources

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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