Advice You - Business

It is easy to dream about an exotic island. It takes a bit more to prepare a trip to this island and spend som

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

e time there. But the real challenge is to take your stuff and migrate to this little island.

It is said that

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

Examples of combination products may in

people that migrate hold on to more conservative customs than in the country of origin. The explanation for th

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

s is that people who migrate carry their historic environment (customs, rituals and ideas of the country of or

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

gin) with them and conserve these carefully because they serve as beacons in the new country where the new emi

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

Combination pro

rant could feel really lost. Perhaps that this myth is less an issue in this modern age where emigrants are in

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

close contact with their home country (and customs) because of satellite television and internet.

The migrat

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

on metaphor is however a more accurate way to describe the impact of a change than the more traditional travel

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

or moving metaphor. Each of the three metaphors -- journey, removal and migration -- has a unique view on chan

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

e.

In a journey the emphasis is on how the change (journey) is affecting a person. A voyage starts with a dre

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

m. Then the dream comes true and before you know you are due back.

Moving to another city is another way to d

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

Following aspects would a

escribe a change and than the environment is most important. You still act the way you did as before but with

dd to the challenges in developing combination products:

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

ifferent people and in a different setting. Also here, the (new) environment will influence people to change.

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

ere too, the move starts with a dream, but in difference with the trip, if you do not like your new destiny yo

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

are to stay. At least you should try, before you call the whole thing off.

The migration is much stronger th

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

n both the journey and the removal; it is a change with the highest impact of the three. Basically the differe

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

Professional from academic institutions, pharmaceutical industries, health care indust

nce is that there is hardly a way back.

The three metaphors as presented here could help you in your plans, p

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

eparations and decision to change what ever situation. And the most important question to answer is: “how far

.

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

ould I go? What is my propensity to change?” just ask yourself. Is a journey enough? Am I prepared to move to

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

Companies that provide selfless information through particip

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.adviceyou.org.ua/article/13978/adviceyou-Your-Propensity-to-Change--How-Far-Would-You-Go.html">Your Propensity to Change - How Far Would You Go?</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/13978/adviceyou-Your-Propensity-to-Change--How-Far-Would-You-Go.html]Your Propensity to Change - How Far Would You Go?[/url]

Many corporate managers have been introduced to a corporate management system called the Balanced Scorecard. Developed at the Harvard Business School by David Norton and Robert Kaplan in the early 1990s, the Balanced Scorecard (BSC) represents the newest and most prolific performance measurement system since Total Quality Management (TQM) and Management by Objectives (MBO).

Does the signage in your company make people do a double take? Do they look back to see what it says? Does it spark curiosity in the viewer? What I am asking is; does your company have a signage double-take strategy to capture the mind and attention of your future customers?

The secret to big success is branding. Yes, the whole branding package include look, attitude and you company's beliefs.

Tags

Links

Advice You - Your Propensity to Change - How Far Would You Go?

Related Articles: