Advice You - Business

It is a wide spread secret that many business projects fail or never meet their original deadline or plan and are only saved because of a c

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

ontinuous and renewed budget increment. There are many factors that contribute to the success of a project or the failure of the same. T

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

Examples of combination products may in

is viewpoint of this article is about project success and productivity.

With productivity in this sense is meant the impact and the produc

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

tive element of the project:

Projects with a high success rate are those that relate to real production or maintenance. For example all th

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

se projects that will introduce a new product. Besides the success of the acceptance of this new product, the project on itself has high su

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

Combination pro

cess rate. It is often a tangible product that requires input and is in fact quite straightforward. The fabrication of a new product falls

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

in this category, or something like an advertisement.

Projects with a lower success rate are those where the main objective is not product

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

ve like in the previous sense. Examples of these are:

Project to standardize corporate systems: like the initiative to replace two

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

different ERP systems by one overall from a single supplier.

Other initiative to come up with a synergy (one central office soft

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

ware, etc)

Project that are needed to connect other initiatives (systems, organizations, etc). The difficulty with these projec

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

s lies in the owner of the problem. Who owns this problem? And who will benefit from it? The introduction of the EURO falls under this cate

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

Following aspects would a

ory. This project was a success only because they absorbed every other budget in the company. Budget was then not an issue, but normally is

dd to the challenges in developing combination products:

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

.

A third category of high risk projects are those that are infrastructural. These are hard to manage just because they are not

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

isible and they provide a fundament for other business to operate on. Famous Examples are; airports or new railways (which requires that la

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

downers need to be expropriated) or in business; new operating systems or the initiative to change from local Office Software on standard P

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

C to a central approach where the software is installed on a central server. A more actual example would be to move your centralized Office

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

Professional from academic institutions, pharmaceutical industries, health care indust

software to an external server (outsourcing).

Many government initiatives have also a high risk profile. These are service oriented projec

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

s that offer a certain service to a large group of people. For one thing this has to do with (an extended) scope for another it is about th

.

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 possible number of exceptions that need to be taken care of in the project. And then there is also the element of confidence. A voting sy

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

Companies that provide selfless information through particip

tem would fall under this category. Information system could also be added to this category for they are service oriented.

© 2007 Hans Boo

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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He was concerned with the direction a decision was leaning, Jon said on his voice mail. Could I meet him for lunch in the cafeteria before Friday's meeting to talk it through? As peer managers involved in policy implementation, our departments would be impacted by any direction taken. Friday's meeting was with the decision makers; a discussion of pluses, minuses, timetables and resources needed for three options under consideration.

All business managers have been warned against operating in an environment of crisis management. To be a more effective manager and leader, you'll want to know that there are prevalent beliefs about crisis management that need to be understood and discounted. To allow us to examine beliefs that have been assumed for many years, I've described these prevailing ideas as the myths of crisis management in the text that follows.

Executive management franchising teams in franchising companies must decide how they wish to handle disputes in the franchising agreement. More often than not clauses are put into the franchising agreements, which stipulate how disputes between franchise stores and franchisees will be handle.

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