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From the middle of last century until today we have become the "throw away society". Buzz words like "disposable" and "one-use" have been commonplace. Where we u

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

sed to "make do and mend" in the war years we now simply replace items that are no longer functioning or are no longer wanted. Now this is great if we have an ev

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

Examples of combination products may in

erlasting supply of clean energy to make replacement goods and bottomless land fill sites. But we have neither.

In poorer countries this problem is negligible 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 most spending goes on food and essential items, leaving very little to be thrown away. More affluent societies, however, are at last beginning to wake up to th

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

e fact that the throw away lifestyle is not sustainable.

How did we get here? Several factors have conspired to bring about our disposable disposition. The main

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

Combination pro

one is affluence. As western societies became richer, the demand for goods rose. Also, our salaries rose. Manufacturing needed to be faster at pumping out goods.

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

Product design and work practices needed to be changed to accommodate increased volumes and in an affluent society it is hard to recruit and maintain the staff

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

needed to keep these places going. As a result, the factories were located in poorer states at increasing distances from the end user. Electrical and mechanical

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

goods were made with ever fewer serviceable parts to the point where some goods these days are totally sealed and repair is just not possible.

In days gone by a

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

factory would produce finish goods and do a good side business in supplying parts to customers or repair shops. In affluent countries those days are gone taking

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

with them the watch repairer, the radio (and tv) repair man, the cobbler etc etc. Even replacing the battery in an electric wrist watch is often virtually imposs

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

Following aspects would a

ible.

Many authorities around the world are now trying to put the brakes on this trend and even trying to reverse it. They are asking for products to be designe

dd to the challenges in developing combination products:

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

d to allow repair and parts replacement. In some areas - take Europe for example - they are introducing legislation that will force companies to take back (or at

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

least take responsibility for) goods at the end of their life.

I am firmly of the opinion that, as this sentiment takes hold - and surely it will, we will be s

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

lowly warped back to the old days of repair shops and an increasing trade in spare parts. I am also convinced that this mini revolution is nearly upon us.

So h

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

ve a walk down your local high street or shopping centre because it may look a little different in coming years with cobblers, watch menders and tv repair shops

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

Professional from academic institutions, pharmaceutical industries, health care indust

making a come back.

Of course, there have been some companies that bucked the throw away trend. Insect-o-Cutor have always provided spare parts for their fly ki

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

ller machines. An Insectocutor fly killer can often go many years without needing any special servicing (they are guaranteed for 5 years in any case). If, howeve

.

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

r, they do need a spare part, then these are readily available from Arkay Hygiene at www.eeeee.co.uk. This availability is partly explains why it is common to se

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

Companies that provide selfless information through particip

e Insect-o-Cutor products working after 20 or even 30 years. In fact some Insect-o-Cutor fly killers from the 1960's are still around and doing and excellent job

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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