Advice You - Business

Think about the following project to initiate. A company is to select a new software system; for exam

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

ple an Enterprise Resource Planning, or ERP system.

Finding ERP suppliers is not that hard. Internet

; 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 a willing environment to organize this preliminary step in the selection process. Then (or before)

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

you need some requirements and selection criteria. In the next step you should filter the initial gr

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

up to a shortlist of high potentials.

Both in the initial long-list phase as in the next sequence wi

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

Combination pro

th the short-list, you need to match your demand characteristics with those of the suppliers. The cha

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

lenge pops up in asking the (right) questions – this is usually done in a Request for Information (RF

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

I) or in a later stage the Request For Proposal (RFP). This is the challenge to set the questions up

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

n a form that all participants understand the same format.

This is a knowledge management problem. Y

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

ou request information, but behind this information is a huge amount of knowledge hidden. Even if you

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

ask the suppliers to draw some pictures you are not able to compare these. All picture, models and sc

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

Following aspects would a

hemes are most of the time proprietary.

The solution…

The solution is to direct to an independent t

dd to the challenges in developing combination products:

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

ird party. This could be an independent advisor, not offering (software) solutions.

The external adv

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

isor is to prepare a format in which not only the most essential information is gathered (from the su

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

pliers), but also the essential (explicit) knowledge behind it. The demanding company could still se

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

tup its own requirements. The management advisor -- in the role of knowledge broker -- is to translat

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

Professional from academic institutions, pharmaceutical industries, health care indust

these requirements to a universal (not proprietary) form and have the suppliers respond to it.

The

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

Benefits…

objective and independent advice
scalable: the advice could be up to any

.

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

level of detail

It takes care that all participants (including the initiating company) prov

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

Companies that provide selfless information through particip

ide accurate information.

reducing time and (other) resources

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/33004/adviceyou-The-Knowledge-Broker--How-to-Speed-up-ERP-Selections.html">The Knowledge Broker & How to Speed up ERP Selections</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/33004/adviceyou-The-Knowledge-Broker--How-to-Speed-up-ERP-Selections.html]The Knowledge Broker & How to Speed up ERP Selections[/url]

There are many ways to motivate employees. We will take a closer look at the possible motivational tools in this article and will discuss the possible outcomes and the effect it might have on the organizational performance.

IT consulting practices can be done by starting with microbusinesses. Gain confidence by realizing what software and hardware you need to know (and probably already do) to begin IT consulting.

If you own a mobile car washing or mobile auto detailing business then may I suggest to you finding new clientele in the car rental agency business? Why do I recommend this? Well personally having been in the fleet car and truck washing business for almost 3 decades it has served me well cleaning for rental car agencies.

Tags

Links

Advice You - The Knowledge Broker & How to Speed up ERP Selections

Related Articles: