E-Folder - Business

. Are you keeping up with the pace of change? The pace of technology? The pace of your marketplace? The pace of your competition

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

? The 2007 Dilemma is how much do you and your business have to change to keep pace? As a business owner you need to have inform

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

Examples of combination products may in

ation at your finger tips that help you make the best decisions.

Planning for 2007 is a hands on process. You might start by as

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

king some tough questions. Do you recognize the need for change?

Are you prepared to look reality in the face? Are you willing

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

to change the way you do business – and change yourself? Will you turn the plan into action?

Do you have the guts to take you

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

Combination pro

business in new directions?

I would like to lay out a road map that will get you to view your business through a lens that eli

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

minates the distortions of everyday business. Let me warn you, you may not like what you see. But if you are going to meet 2007

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

head on it is a necessary process. Let’s look at what a strategic plan could do for you.

. Develop a statement of purpose. Why

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

does your business exist? Sometimes why we started the business is not the same as why we continue to work it. One of my long t

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

ime clients over the years has added staff, and possibly her successor, so that now she can travel more. The business was starte

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

so she could support her family.

. Conduct a SWOT analysis. This will help you evaluate your business' internal strengths and

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

Following aspects would a

weaknesses, along with the opportunities and threats you face in the market place. It will give you a basis for developing a pla

dd to the challenges in developing combination products:

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

n.

. Crystallize your thinking - Determine what specific long range goals you want for your business. It is never enough to jus

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

t want more money. They should cover all aspects of the business.

. Create benchmarks, with specific results for meeting those

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

goals. It is easier to make adjustments along the way without losing sight of the long range goals.

. Brainstorm strategies for

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

reaching each of the results. There is more than one way to achieve a result, ask others for ideas.

. Develop a Plan of Action

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

Professional from academic institutions, pharmaceutical industries, health care indust

Plan the progressive steps, along with who will do what when. Nothing ever happens without action, but there is a world of diff

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

erence between mere action and constructive action.

. Be confident in yourself and your own abilities. Be determined to follow

.

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

through on your plan, because without determination the plan will deteriorate.

The 8th step is to track your progress. Write ou

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

Companies that provide selfless information through particip

t your numbers (yes I said write), know your sales number, gross profit, cost of goods/time. It is a sure way of staying focused

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.e-folder.org.ua/article/16250/e-folder-The-2007-Dilemma.html">The 2007 Dilemma</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/16250/e-folder-The-2007-Dilemma.html]The 2007 Dilemma[/url]

Paid surveys are increasing in number and scope, reaching millions of people on a daily basis. As more and more companies become interested in receiving customer feedback through paid surveys, more survey companies emerge, offering people the opportunity to earn some cash and prizes as survey takers

Nursing education provides the basic building blocks of medical, scientific, and nursing knowledge, but competence in the nursing profession requires an ongoing process of continuing education. How does the busy working nurse find the time or courses though?

Tags

Links

E-Folder - The 2007 Dilemma

Related Articles: