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When you are deciding on a voice/data network solution for your business the obvious factors to take into consideration are bandwidth and

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

cost. However if you base your entire solution on those factors alone you risk facing issues you could have easily prevented with just a

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

Examples of combination products may in

bit more strategic thought and planning.

The article "Why Do Businesses Prefer T1 And T3 Bandwidth Connections" is a good attempt at add

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

ressing the business issues involved with the decision making process for a small or medium business with limited telecommunications / net

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

ork connectivity needs.

But that is just a start.

For businesses, with more than rudimentary network connectivity needs, there really is

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

Combination pro

much much more involved in driving these kinds of decisions. Also, there are several more technology options beyond T1/T3 (aka DS1/DS3) a

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

nd xDSL. It's also important to understand that Bandwidth and cost, while important, are rarely the only drivers of solutions in this spac

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.

The driver for solutions here is business problems.

What does your business need?

High volume public and/or private network throughp

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

t? Robust Availability with Substantial SLA (Service Level Agreement) guarantees? International reach? Flexibility? Cost Effectiveness

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

? Consistent product/feature availability within a given geographic region? etc.

If a business' telecommunications needs are:

5 or le

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

ss locations with Email, Web surfing and ~20 phones lines or less....than xDSL, Cable or a Mixed Services (integrated) Local DS1 are all o

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

Following aspects would a

n the table as options.

For larger businesses that may have a need for private connectivity between branch locations, to maintain a call

dd to the challenges in developing combination products:

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

enter, host internet or external partner facing servers, or in anyway depend on network connectivity as part of their revenue stream......

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

xDSL or Cable are rarely options.

Businesses in this category need the reliability and "known quantity" of telco services, that tend to

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

leverage DS1, DS3, OC3/12 etc as local access, as a component of availability of their larger solution. Additionally Metro Optical and Et

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

hernet solutions, where available, are increasingly more cost effective and flexible alternatives to copper and SONET based local access s

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

Professional from academic institutions, pharmaceutical industries, health care indust

rvices.

The bottom line when working through a decision on a voice/data network for your business is to look beyond just bandwidth and co

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

st. You must also consider the requirements and impact for your existing AND future applications, infrastructure, volume, network stabili

.

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

ty, security/privacy, partner/customer interface, and supplier connectivity. Ensuring all these factors are considered will ensure your s

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

Companies that provide selfless information through particip

olution addresses all possible business requirements....... and prevents the potential for embarrasing or frustrating issues in the future

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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