Advice You - Business

STEP 3: Prepare a Business Plan

Once I have done all the preparations, I would start creating a detailed business plan -

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

a document that will provide the priorities, strategies, agenda and sanity I’ll need to startup my business.

In my experience an

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

Examples of combination products may in

observation of the business world, the “activity” of creating a business plan is as valuable as the end product itself. Just rem

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

ember that the most important audience for a business plan is ME. I am accountable for all the statements, claims, statistics and

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

facts. So if I try to “twist” the figure, I am actually lying to myself!

The business plan can also aid me as a tool to generate

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

Combination pro

interest from financiers, venture capitalists, staffs, suppliers and strategic associates.

Regardless of the structure or format

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

of my business plan, I will ensure that my business planning must contain answers for the following twelve questions:

1. What’s

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

my business idea?

2. How does my idea address consumers’ needs/wants?

3. What business model suits me best?

4. What’s unique a

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

out my business idea over the rivals?

5. What is the market opportunity and potential?

6. What is my role and responsibility?

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

7. Who are the key staffs or workers (skip if I do not have any)?

8. What price will the customer pay and how will they buy?

9.

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

How much money do I need to start and run the business?

10. What’s the source of my capital?

11. How will I measure the success

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

Following aspects would a

of my business?

12. What are my key milestones?

While preparing my business plan, I would cover all the elements of a business

dd to the challenges in developing combination products:

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

plan shown in DAY 3. Just for your study aims, I have attached a sample business plan at the end of this section.

I must ensure

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

hat my business plan is concise and neatly formatted (i.e. Microsoft Word document for the bulk of the plan, with any financial d

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

cuments as attached spreadsheets in Microsoft Excel), and need not include fancy graphics, flowery language or photos. The easier

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

I make it to read, the better.

Alternatively, there are occasions I work better with business plan templates and wizards. Hence

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

Professional from academic institutions, pharmaceutical industries, health care indust

I would search online as there are many business planning software packages available that only cost in the neighborhood of $100

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

as well as a few free online business plan templates. I would normally spend some time searching for the right software or templ

.

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

ates to aid me in constructing my business plan.

Disclaimer - This article may be freely reprinted in its entirety in any e-zine

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

Companies that provide selfless information through particip

newsletter, blog or website. The author’s name, bio and website links must remain intact and be included with every reproduction

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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What is the perfect desk? Your desk should reflect the professional that you are. When colleagues visit your office, the best role model you can set is to be organized and in control. Set up workflow systems that support your goals and allow you to be doing the most important tasks in a timely manner. Follow these 5 strategies to maintain your desk. You will be more productive, more professional and less stressed.

all too often the concept of innovation is intricately linked with radical change. In fact, the opposite is true:

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Advice You - 10 Step-by-Step Business Startup Guide - Step 3

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