E-Folder - Business

How often we are reading or hearing about jobs and industries being lost in the West and moving East? People, particularly the business and poli

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

tical leaders, are all complaining about it but does anyone look at why it is happening. It goes right across the board, starting with manufactu

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

Examples of combination products may in

ring, IT call support centers, banking support centers, and so much more. When one first looks at this, it appears that the West is losing these

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

business opportunities but perhaps the truth is not in the appearance.

An example which I believe is a microcosm of what actually is happening

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 taken from a client experience. One of my clients has developed a children’s drink. Within the prototype phase, we were able to have samples

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

Combination pro

manufactured and bottled on the Continent. Our testing showed that there appears to be a market, but based on a variety of other factors, a deci

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

sion was made to change the packaging and the form of the drink. These changes necessitated finding and working with other packaging companies.

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

During this process, we learned that many of the companies do not even respond to requests for any assistance at all. Numerous requests and even

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

attempts to elevate the questions to people higher within these large organizations fail to bring forth any response. These are the same organi

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

zations that are moaning to the press and anyone else that will listen that they are losing market share, losing jobs and need to have tariffs or

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

other penalties lodged again the businesses coming from the emerging markets.

It begs the question of what is driving the change. Is it that pe

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

Following aspects would a

ople are forever seeking the cheapest price and willing to go to the other side of the world to get it? Or is it that the companies located near

dd to the challenges in developing combination products:

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

by are so confident that people will accept any type of service they choose to give that they falsely think they do not have to provide service a

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

t all? Looking at these questions in more detail, it seems a reasonable assumption that most people, including people within organizations, wo

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

ld prefer to do business with someone that they can see, meet with and feel a connection to physically – not just over the Internet or a telephon

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

e. This is a natural order for us and our approach to our world.

So when people and companies are looking to other countries, cultures and plac

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

Professional from academic institutions, pharmaceutical industries, health care indust

es to do business where it is difficult, if not possible, to verify that it really is a business and that the promised products and services will

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

be delivered, where there are language barriers – is that the choice because they think it will be better or because these are the people that ar

.

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

e responsive to their questions and requests?

Company leaders should take a good and honest look at their organizations and answer the question:

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

Companies that provide selfless information through particip

are we losing the business to the East or are we giving them the business?

Copyright, October 2006, Susan Bagyura, Blue Danube Coaching Limite

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.e-folder.org.ua/article/14813/e-folder-Business-Opportunities--Are-We-Giving-The-Business-Away.html">Business Opportunities: Are We Giving The Business Away?</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/14813/e-folder-Business-Opportunities--Are-We-Giving-The-Business-Away.html]Business Opportunities: Are We Giving The Business Away?[/url]

Every consultant has had the feeling: the conviction that your own private service practice is your true calling. Your passion quest. Yet, the mundane details of actually running a business make even the most inspired business person ask whether the choice was the right one.

Own luxury goods at Wal-Mart Prices: When the government auctions off property, all closing bids are final. Many people attending government auctions for the first time can’t believe the prices! Everything you buy at the auction is yours to keep – no strings attached.

So you've decided to run a print ad in your local newspaper. The paper may have even told you they could produce the artwork for you if you just tell them what should be in the ad. Problem is, you're not sure what should be in the ad.

Tags

Links

E-Folder - Business Opportunities: Are We Giving The Business Away?

Related Articles: