Main Subject - Business

Lenders and investors may see hundreds of business plans in a single day. Make your business plan stand out against the rest, and avoid

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

these common mistakes.

1. Not proving that you have the management expertise to make it happen. The quality of your people will lend

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

Examples of combination products may in

credibility to your ideas and even to your financial projections. If your management team is not as strong as it could be, join forces

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

with a great board of advisors.

2. Not demonstrating where your revenue will come from - what customers pay you and why they pay you.

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

Don’t be too aggressive in setting revenue projections or you will undermine your credibility.

3. Not proving that your business model

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

Combination pro

and long term cost structure is good enough to make a real profit. How will your business make money - what is your margin structure, w

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

hat are your costs?

4. Not being clear enough in your product description to allow the reader to quickly see the need and the niche fo

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

r this product. It may seem obvious to you, but not so to the reader not educated in your business.

5. Not proving that the market opp

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

ortunity is big enough to get interested in. How big is your market now and what will it look like in 5 years?

6. Not adequately ackno

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

wledging your competition. Investors know that if there is no perceived competition, there may be no market for what you are offering.

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

he better you can describe your competition, the better you understand your market, and the more likely you will dominate it.

7. Not w

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

Following aspects would a

riting for the target audience. Although the core is the same, the plan should be written for the perspective of banks, equity investor

dd to the challenges in developing combination products:

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

s, and others. Go as far as you can to tailor each plan to the audience’s specific interests to show you’ve done your homework and know

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

to whom you are talking.

8. Starting with a boring, unenthusiastic executive summary. This is the first section to be read, and if it

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

isn’t exciting the rest may never be seen. Make it fun and be enthusiastic. It should stand alone and generate interest for more. It d

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

eserves all the thought you would put into a professionally done promotional piece for your customers.

9. Poor presentation. If you ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

e typos and grammatical errors in your business plan, the reader will assume the work you do in your business is sloppy too.

10. Sayin

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

g too much. Keep the entire plan to a maximum of 30 pages, with an executive summary of 3 pages or less. If investors are interested, t

.

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

hey will ask for any other information they need. Amateurs talk in the business plan about unimportant details because they don’t know

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

Companies that provide selfless information through particip

what they should say and what they shouldn’t. Hire a professional editor to reduce the page count and help you emphasize your strengths

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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