Main Subject - Business

Successful enterprise building requires seven elements. These are:

1. People, who are the source of the creative ideas which drive the enterprise’ s innovations;

2. Financial Resources, to fund the transformation of these ideas 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

nto market breakthroughs;

3. A Coherent Business Philosophy, from which the enterprise sets its course;

4. Capable Leadership, in order to properly direct and manage the enterprise;

5. Strategies and Tactics, to focus the enterp

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

Examples of combination products may in

ise’ s strengths and minimize its weaknesses;

6. Marketplace Intelligence, allowing its people to understand the changing forces in the environment which are producing both the windows of opportunity as well as potential dangers,

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

and finally;

Time, for it is only with adequate time that the creative ideas, properly nurtured, directed and implemented, can fully blossom into successful innovations.

Unfortunately today, even when the first three are presen

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

, the pressure for immediate bottom-line results frequently culminates in knee-jerk management reactions, that handicap the development of a creative inspiration into a major market success. Time is indeed a precious commodity i

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

Combination pro

n today’ s rapidly changing and evolving marketplaces. As a senior executive advisor, professional speaker and business owner, I have always been an advocate of taking action, as I frequently meet well intentioned executives, who

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

are reluctant to make decisions. Therefore, delay and procrastination have become their nagging companions. “He who hesitates is lost”, a favorite axiom of mine serves as a fitting dictum for strategic and tactical decision makin

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

g. However, it is possible to misapply this tenet to the unique process of nurturing creative ideas into market breaking innovations. Although the old adage, “time waits for no man” is true and needless delay should not be tolera

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

ed, many excellent new ideas have been compromised or even destroyed by a short sighted quest for immediate returns.

The farmer in springtime first plows, then plants, but he does not rise early the following morning hoping to be

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

gin the harvest, does he? Of course not. He expects to wait months for his crop, during which time he must repeatedly fertilize and then weed, if he expects a bountiful harvest. It is that frequent fertilizing, “nurturing and en

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

ouraging”, along with the repeated weeding, “directing and guiding” which cannot be short-cut, if creative ideas are to mature into breakthrough market innovations. However, it is just this waiting which so often bedevils us. Ten

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

Following aspects would a

years ago the advent of the personal computer industry spawned the euphemism “vaporware”. Today most industries sport their own versions of “vaporware”, if not in form, then certainly in substance. Creative ideas, many very prom

dd to the challenges in developing combination products:

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

sing ones, are repeatedly rushed to market before ready. The consequences; unhappy customers, damaged reputations and often diminished long term profits or worse yet, abandonment of what could have been a revolutionary new produc

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

t or service.

There is a classic line in the movie “The Princess Bride”, where Miracle Max is trying to revive the “mostly dead” hero, Wesley. Feeling the pressure from Wesley’ s friends to hurry, Miracle Max responds; “You rush

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

miracle and maybe you get rotten miracle.” Well said Max! Too many executives today are wondering why they keep ending up with rotten miracles. Frequently they need look no further than their own myopic quest for instant profit

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

s. Growing up in the 50’ s and 60’ s, when I heard people speaking of long term plans, they were referring to decades. When I began my career in the early 70’ s, long term business plans had shrunk to five to ten years. Today, lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

g term is anywhere from one to three years or less. No wonder senior executive focus is so severely constrained by monthly or quarterly results. If creative ideas are not in and of themselves small miracles, then certainly the ac

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

t of transforming those flashes of insight and even genius, with their potential to suddenly propel an enterprise several years ahead of its competitors, undoubtedly is miracle making in the marketplace. Far too many creative ide

.

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

s of great promise have resulted in “rotten miracles,” due not to the ideas themselves, but rather because they were prematurely transformed into “vaporware” by executives, impatient for immediate results.

In order to consistent

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

Companies that provide selfless information through particip

ly succeed at turning creative ideas into breakthrough innovations, they must be tended with diligence and patience like choice grapes in a vineyard, until you are rewarded with a truly fine wine.

Copyright 2005 by John Di France

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.mainsubjects.org.ua/article/24323/mainsubjects-Miracle-Max-On-Market-Breakthroughs.html">'Miracle Max' On Market Breakthroughs</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/24323/mainsubjects-Miracle-Max-On-Market-Breakthroughs.html]'Miracle Max' On Market Breakthroughs[/url]

Branding yourself, products, or services, buyers will not only recognize your name, they will also begin to know about your quality.

This article outlines the process you should follow when you are starting your home business. Thoughts on how prepared you need to be when you are ready to jump and quit your job.

All mobile oil change business entrepreneurs constantly consider and think about their market mix. Should they concentrate on Fleets of Vehicles for companies or on personal cars or oil changes for employees at their offices?

Tags

Links

Main Subject - 'Miracle Max' On Market Breakthroughs

Related Articles: