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You’ve probably not given much thought to who owns what in your local telephone exchange but unknown to

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

many of us; broadband providers have added their own equipment into your local BT exchange. This direc

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

Examples of combination products may in

t access enables them to give their customers many different services and reduce cost.

So, what does t

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

is mean to the average consumer?

Well a few years ago, when signing up to broadband deals, you would b

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 effectively running solely on BT’s wholesale network branded as another supplier. BT sells these ser

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

Combination pro

vices via their wholesale arm and internet service providers (ISPs) go on to brand and manage the servi

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

es on their own.

Times have now changed and regulator Ofcom has set in place something known within th

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

e industry as “Local Loop Unbundling” or LLU. This means that broadband providers can bypass the BT ne

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

twork and install their own equipment in your local exchange.

You may think of this as good news, pote

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

tially reducing the cost of your broadband connection but unfortunately this isn’t always the case and

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

has led to different prices for broadband in different areas and also huge differences in quality of se

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

Following aspects would a

rvice.

The majority of complaints about pricing and poor service come from people living in rural area

dd to the challenges in developing combination products:

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

because providers have rolled out their LLU networks in urban areas where they can cover the widest nu

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

mber of people in the UK and also control cost, (i.e. it’s more cost effective to have LLU in urban are

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

as as they can maximise the number of potential customers and maximise revenue).

The likes of AOL and

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

alk Talk (Both owned by Carphone Warehouse), Tiscali and UK Online are charging over the odds to custom

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

Professional from academic institutions, pharmaceutical industries, health care indust

ers outside of their LLU network and this is usually in rural parts of the country.

Other providers su

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

ch as Orange and Pipex have chosen to take a different route and are winning customers by choosing not

.

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

o pass this charge onto their customers.

With the difference of around ?10 per month, it’s not wonder

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

Companies that provide selfless information through particip

customers are up in arms and worth checking to see if you’re affected before choosing your new provider

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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