Digg It - Business

Angelo Pietromonaco, a rubber product supplier and manufacturer based in Melbourne, Australia has made many changes i

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

n his business activities to stay ahead of a difficult market.

It is a well-recorded fact that Australian businesses

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

Examples of combination products may in

are finding it near impossible to compete on the world market. Traditionally, Australia has boasted a strong, indepen

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

dent base known for producing innovative and well-designed products – who hasn’t heard of the Hill’s Hoist?

Angelo h

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

s seen a lot of changes happen in a very short amount of time.

“The changes all happened very quickly and caught a l

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

Combination pro

ot of solid Australian companies totally unaware” states Angelo, “ One moment we were all in an established and what

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

e thought was a solid market, the next we were being decimated by cheap foreign imports – so cheap, a lot of Australi

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

an companies couldn’t compete.”

Angelo has survived the onslaught of imported products. As a supplier and manufactur

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

r of rubber products, the company saw that a lot of the manufacturers it was supplying too were either relocating abr

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

oad or shutting down. Angelo became quickly aware that he needed to create a specific market focus.

“We knew we had

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

o develop a range of niche products to survive,” says Angelo “a range of products we are quickly able to supply at re

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

Following aspects would a

sonable cost to our Clients. We also realised that by offering a bespoke service we could provide fast turnaround for

dd to the challenges in developing combination products:

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

our Clients – a fact they really appreciate.”

“It boils down to the fact that we can’t afford to get it wrong,” say

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

Angelo, “ a lot of our Clients who have used overseas suppliers found that the product they ordered wasn’t the one d

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

elivered, or that the specifications weren’t correct – there are a myriad of reasons that all resulted in delay or do

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

ntime that ultimately cost them more than if they had used us in the first place.”

Angelo is upbeat about the future

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

Professional from academic institutions, pharmaceutical industries, health care indust

:

“Australian business has been through a terrible time and will continue to be challenged for a long time to come,”

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

continues Angelo “ to survive, we know we must have the skills and ability to create a really first class product 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

ked with a first class service, and we’re doing this and striving to stay ahead – it’s a hell of a challenge, but our

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

Companies that provide selfless information through particip

determination to provide quality backed with outstanding service makes us, in my eyes, better than any other country.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/40954/diggit-The-Uncertain-Future-of-Business-the-Questions-You-Need-to-Ask-Yourself.html">The Uncertain Future of Business: the Questions You Need to Ask Yourself</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/40954/diggit-The-Uncertain-Future-of-Business-the-Questions-You-Need-to-Ask-Yourself.html]The Uncertain Future of Business: the Questions You Need to Ask Yourself[/url]

If you want to see new opportunities for your business and increase your decision-making speed and accuracy, begin by looking outside your own business- even outside your industry- at trends and patterns that you can apply to your own organization.

Setting up a compelling trade show display panel goes way beyond purchasing the standard tabletop display that everyone already has.

The Federal Trade Commission, the FTC, has announced that it's outlining new laws to protect consumers from Get Rich Quick and Work From Home opportunities, and some new laws to prevent people from creating these same opportunities.

Tags

Links

Digg It - The Uncertain Future of Business: the Questions You Need to Ask Yourself

Related Articles: