Advice You - Business

If you're about to start a business (or approach a financial institution for funding to expand your existing business), then you must have a business plan. Your plan allows y

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

ou to set your goals, assess your strengths and address your weaknesses.

You wouldn't set out on a journey not knowing where you were going, yet many people establish a busi

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

Examples of combination products may in

ness with no real concept of what they want to achieve or how they'll achieve it.

The outline below shows what you need to include in your business plan; use it to gather th

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

appropriate information so that you get your business off to the best start.

EXECUTIVE SUMMARY

Quote (about your vision for the business)

What already exists

The niche -

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

- as you see it and benefits your business will bring

Type of business proposed -- benefits you will bring to the market niche

Overall financial goals -- anticipated sales

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

Combination pro

nd profits

Funds required to start up business

BUSINESS PROFILE

Business name

Principals

Description of business:
• what it aims to do
• its target market

Vi

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

sion -- ultimate goals

Mission -- value, service you'll offer

Competitive advantage you have -- e.g. flexibility, able to draw on wide base of talents, connections in the i

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

dustry etc.

SWOT analysis [Strengths Weaknesses Opportunities Threats](Be honest with these, but only put in threats, weaknesses that you know you can meet and overcome succ

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

essfully)

Objectives:
• at the end of the first 12 months of operation
• after 12 months

PRODUCT AND MARKET ANALYSIS

Product / Service -- description of what you

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

re offering

Features

Benefits

Price structure

Industry description and outlook

Market demand -- percentage of market you think you can capture; competition share you thi

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

nk you can take etc.

OPERATING PLAN

Resource requirements:
• what you need in order to operate
• what this will cost

List items and specify prices (tables etc)

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

Following aspects would a

MANAGEMENT PLAN

Manning levels:
• details of staff required
• training needed

Experience of managers and their skills

MARKETING PLAN

Divide this into: Internal

dd to the challenges in developing combination products:

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

- how you'll win repeat customers and referrals

External - how you'll get new customers

Impact - how you'll target specific groups

Detail how you'll go about targeting and

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

selling to each group e.g.

Service levels
Vouchers
Hand-outs
Music
Decor
Entertainment
Special add-ons
Etc.

Publicity and direct approac

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

es you'll make (specify targets e.g. music schools etc)

Promotion (e.g. freebies, discounts, buy one get one free, every 6th something free, charity performances, openings e

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

tc)

The actual product / service you're selling

FINANCIAL PLAN

Details:
• Projected sales
• Projected costs
• Projected profits

Give SPECIFIC details e.g.

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

Professional from academic institutions, pharmaceutical industries, health care indust

reak down into gross profits, overheads, net profits etc.

ACTION PLAN

Use table to show:
• Activities to be carried out
• When these will be done
• Who wil

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

l do each

Give a chronological sequence of action to show how you plan to start and develop the business.

Provide plenty of graphs (use different styles), tables, facts and

.

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

figures.

Get info from Bureau of Statistics on demography, socio-economic groups, age etc etc.

Have AN appendix and include any extra details (for example: newspaper cuttin

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

Companies that provide selfless information through particip

gs about bands bemoaning the fact that they can't get their CDs cut etc).

By following this outline, you'll have a realistic goal for your business ... and your bank manager

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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