Advice You - Business

Here are 5 common reasons why your projects are going over schedule, over budget, and generally under expe

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

ctations of quality.

1. Overextending on your resources: Or simply doing more than what your re

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

Examples of combination products may in

sources whether it be in finances, human capital, strategic partnerships, time, etc.

2. Microman

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

ging: Instead of looking over the shoulders of your team mates, focus more on the overall strategy alignme

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

nt and faciliate intra/extra departmental communications.

3. Lack of strategic vision, feature-cr

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

Combination pro

ep, too tactical (putting out fires, playing catch-up vs how to sustain long term competitive advantage)

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

r>
4. Eating an elephant whole: no matter how well thought out the project is, the individual pieces

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

may be perfectly executed on time and on budget but then it's impossible or extremely difficult to integra

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

e the pieces. Instead it is probably a better idea to chunk out the projecs to produce measurable results

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

such as described in the "rapid results initiative" where specific quantifiable milestones are set, and on

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

e reached can be either built upon or scrapped depending the the goal discovery process.

5. Poor

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

Following aspects would a

communication between cross-functions: Bureaucracy is part of the game, get used to it, or better yet, lea

dd to the challenges in developing combination products:

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

rn to be a better communicator and have not just let the marketing or engineering head decide on the proje

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

t requirements but set aside time to get insight from all constituents and stakeholders.

The

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

untold story, beyond financial losses

Not only do failed projects cost time and money, som

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

times amounting to several years, and millions of dollars. But it demoralizes all the stakeholders to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

project, especially the frontline employees and managers that had direct reign and input into the project.

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

As has been quoted in the media and surveys, the majority of projects fail to meet expectation

.

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

or even sustainable results. Therefore an improvement in the knowledge of the field of project management

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

Companies that provide selfless information through particip

is perhaps the bare minimum in advancing one's career, or business success in this high paced environment

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/23596/adviceyou-Why-Your-Projects-Are-Not-Being-Completed.html">Why Your Projects Are Not Being Completed</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/23596/adviceyou-Why-Your-Projects-Are-Not-Being-Completed.html]Why Your Projects Are Not Being Completed[/url]

Taking a break can help you feel less burned out. It can help you organize your life goals. Most people don’t realize that taking time off--guilt free--isn’t as difficult as it might seem.

What are the combination of factors that make Wellness such an attractive business opportunity?

Good financial management does not have to be complicated. Imagine learning how to set up an intelligent and easy-to-use and manage business accounting system in about 5 minutes--that's what this article will show you. a MUST read for beginners!

Tags

Links

Advice You - Why Your Projects Are Not Being Completed

Related Articles: