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1. Question the franchisor: The decisions that you make about your potential business will need to be based upon information from very pointed questions to the franchisors. Questions such

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

as, what is the initial franchising fee. These fees vary from franchise to franchise and could run as high as several hundred thousand dollars.

More than likely you will also be required

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

Examples of combination products may in

to pay an advertising fee to help promote the franchise. You will need to know the amount of that fee, or how it is figured (sometimes figured on a percentage of sales) and how much of t

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

hat is used for local advertising and how much for national exposure.

Royalty payments are payments to the franchisor for the use of the franchise name. These are usually figured as a p

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

ercentage of weekly or monthly gross sales. Again this number can vary from franchise to franchise and should be well understood before proceeding.

Find out the terms of the franchise a

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

Combination pro

greement, including the period of time that the agreement will last (usually 5 years), how can you terminate that agreement and what the guidelines are around the franchisor terminating

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

it.

Finally, some franchises will require you to do financial reporting each and every day along with upholding the uniformity of their system in each franchise. Inquiring if there is 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

ome flexibility will assist you in making a better decision about the franchise that suits your needs. You will also need to ask yourself if you can live with these processes or if it to

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

o stifling to allow you to exercise your own judgments in business.

2. The U.F.O.C. (Uniform Franchise Offering Circular). Much of the information above will be listed in the UFOC. It wi

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

ll be extremely important for you to peruse this circular very closely and even have a professional review it before signing any contracts.

3. Now if you have gotten this far with a parti

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

cular franchise you will want to talk to someone who is actually running their own franchise. Try to get a couple of different prospective of the business. You must realize that some of th

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

Following aspects would a

e ones you will talk to will give you a negative outlook on the business. Your challenge will be to sift through all that to make the best decision for you and your goals. Below is a list

dd to the challenges in developing combination products:

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

of possible questions that you may want to ask the franchisee.

• Are you happy with your franchise?
• What kind of income is you franchise generating?
• If you had it to do over

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

again, would you buy the same franchise or another?
• Was the training thorough, how long was it, and did you like it?
• Are the franchise fees you are paying the same as your

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

interpretation of the agreement, or are they more?
• What type of business experience did you have before purchasing the franchise?
• Were there any hidden franchise fees or une

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

xpected costs?
• Did the franchisor estimate the amount of operating cash you would need correctly or did they underestimate?
• Is your territory big enough to hit your goals?

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

Professional from academic institutions, pharmaceutical industries, health care indust

> • Can you sell other products or do you have to sell and use only theirs?
• Does the franchisor advertise as much as they said they would?
• Does the franchise give you an exc

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

usive territory for the length of the franchise period.
• If needed, will the franchisor assist you in finding a location that is suitable
• What determines a territory

Before y

.

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

ou make any decisions, make sure you get any agreements in writing and consider getting professional advice. Check with a lawyer for the legality of the business and to make sure you fully

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

Companies that provide selfless information through particip

understand the contract. An accountant can review the finances and promised income. The money and time spent seeking professional advice can save you from making a bad business investment

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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Your Space - Franchise Opportunity Tips (Part 2)

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