Digg It - Business

Getting people into your business does presuppose that you'll take their advice!

I've only ever found two companies who didn't want to g

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

row their business! And a recommendation I made to one of the companies would have doubled their turnover, with practically no work on th

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

Examples of combination products may in

eir part!

You don't need to let hidden opportunities or threats stunt your company growth. It's simply a matter of having the courage to

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

employ someone who can stand outside your business, whilst understanding its principles and give you an unbiased report.

Who Sh

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

ould You Employ To Act As The External Observer? To get the best from your consultant you need someone who:

Is willing

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

Combination pro

to investigate the company and do the necessary analysis

Has been into at least 5-10 different companies

Has worked

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

for at least one blue chip company as a permanent employee at some stage

Is not a specialist, such as an accountant, lawyer or

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

banker

Not a "friend"

The reasons you need these criteria to help you choose a consultant are:

Consultants can come

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

with the "one size fits all" approach and their strategy is a very rapid visit followed by a boiler plate report. In which little that wi

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

ll help the company is detailed. leaving the company exactly where it was before. The positive side to this is that it doesn't cost much.

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

The downside? It's a waste of time.

Another consultant's approach is to flood the company with bodies (so called "leveraging").

The re

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

Following aspects would a

sulting report is more likely to be tailored to the client. However, the downside is the enormous cost and as the consultancy is likely t

dd to the challenges in developing combination products:

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

o want further work in the company the worst areas may not be highlighted as they should. Or the consultant may push their own solution,

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

involving their resources, when there's an easier, cheaper approach.

If the consultant hasn't worked in at least 5 other companies they'

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

re unlikely to have seen how other operations run and to understand that whilst every company is different there are some
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
> common lessons that can be drawn.

Working at a blue chip means the consultant has had great training. Their approach should reflect th
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
is training. From the initial meetings right through to the final report.

Avoid specialists as often they're blinkered by what they see
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
at a company. Yes they're likely to see at least some of the problem areas for the company. However, their relationship may hold them bac
.

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
k from being candid. In addition they are unlikely to see the opportunities that a company is missing.

Lastly don't use a friend. Becaus
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
e friends may be too hard on you and your staff, demotivating you. Or they may be too soft and ignoring problems that need to be resolved

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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Digg It - Are You Stunting Your Business Growth? (Second Article of 2)

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