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Many companies wish to expand and a few wish to use franchising as a method of expansion. Not a bad idea, but one must consider the importance of the fine details. One book I recommend you read is the “E-

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

Myth” by Gerber it is available at all the usual places. You see when going from a small business to a franchise company it is important to make sure you take out all the mistakes you have made in the pas

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

Examples of combination products may in

in building your small business and insure that your future franchisees never make those mistakes themselves. After all they need not go thru the rigorous minefields and brick walls you had to in order 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.

be successful. Especially considering you will most likely be charging them a substantial upfront franchise fee.

Many new franchisors know they need an Official and Confidential Operations Manual, yet

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

since it is such a daunting task they often favor the idea of hiring someone not involved in their business to do so for them. The fees for operation manual writers is quite high and indeed it was my reas

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

Combination pro

ning to write my own for our franchise company, which happens to specialize in Mobile Car Washing and Detailing. www.CarWashGuys.com . After completing the manual, which is always under constant revision

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

as markets change and consumer buying behavior trends ensue, I found that not only was writing my own operations manual a cost savings; it was imperative.

A good Franchise operations manual will end up a

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

bout 500 pages, mine ended up over 1000 typed pages with about 10,000 hand written notes and sub topic accumulation of forms and ideas of the past 20-years. After going thru this process of designing what

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

I believe is the best franchise company ever created, I realized that you never fully understand your business completely until you put yourself, employees, customers, cash flow and procedures under a mic

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

oscope. I can tell you that when you finally do this, you will be humbled indeed. I suppose that is a good thing, even though us entrepreneurs seem to have above average egos.

So with this said let me fi

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

st say, I cannot give you our manuals for free, generally our perfected business model is sold in the form of a franchise and the franchise fees are generally $20,000 up front. But as an entrepreneur I wi

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

Following aspects would a

ll give the basic outline, which you need to write your own. Which if you intend to franchise your current business, I highly recommend you do it yourself or with a close in-house team. If you choose to h

dd to the challenges in developing combination products:

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

re a writer, pay a little extra and spend a little more time putting all your ideas into a tape or digital recorder so that the true important details are not lost in the political correctness of a Manual

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

Writer. Remember I am in a service, home based franchise company and you company will be slightly different and therefore your manual will also be somewhat modified, but I assure you this is where you nee

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

d to start. Try to have at least 20-pages for each item and then once you state using bullets, paragraphing, formatting and illustrations you should be closer to 35-40 pages for each topic. Here is the ou

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

line and best of luck and continued success in your business.

OFFICIAL OPERATIONS MANUAL

I. IMAGE

II. COMMUNITY RELATIONS

III. CUSTOMER RELATIONS

IV. MEDIA RELATIONS

V. EMPLOYEE RELATIONS

VI.

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

Professional from academic institutions, pharmaceutical industries, health care indust

VENDOR RELATIONS

VII. OTHER FRANCHISEE RELATIONS

VIII. FRANCHISOR RELATIONS

IX. LOCAL GOVERNMENT RELATIONS

X. BUSINESS COMMUNITY RELATIONS

XI. COMPETITION RELATIONS

XII. ABOUT VEHICLE

XIII.

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

MAINTENANCE OF EQUIPMENT

XIV. ENVIRONMENTAL CONCERNS

XV. WATER PURIFICATION

XVI. INTER COMPANY PROCEDURES

XVII. ACCOUNTING AND BILLING

XVIII. BANKING AND CREDIT CARDS

XIX. FINANCING

XX. ROYA

.

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

TIES

XXI. COMPUTER PROCEDURES

XXII. SUPPORT (COMPUTERS)

XXIII. SCHEDULING TIPS

XXIV. QUALITY CONTROLS

XXV. ASSOCIATIONS

XXVI. INSURANCE

XXVII. SAFETY

XXVIII. WASHING PROCEDURES (VEHICLES)

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

Companies that provide selfless information through particip

XXIX. INDUSTRIAL AND SPECIALIZED SERVICES

XXX. TERRITORY LIMITATIONS

XXXI. RECORDS TO BEAT

XXXII. UNDERSTANDING OUR FOUNDER, COMPANY HISTORY

XXXIII. FUTURE OF FRANCHISOR

XXXIV. FOUNDER’S MESSAG

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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