Advice You - Business

Every Franchise Opportunity comes with an Operators manual. This is the cornerstone of every franchise business. A well written and properly set out manual can easily

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

make the difference between having a successful franchisee or a failure. Many franchisors do not dedicate as much time and effort in their operators manual as they sho

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

Examples of combination products may in

ld.

I believe that a franchise business operator’s manual has to have the following:

Detailed instructions on how to run and manage the business properly. Most franc

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

isees do not come from business backgrounds and therefore need taught the basic skills of how to manage a business during their training programme. These guidelines sh

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

ould be laid down neatly and concisely in the operator’s manual.

Every aspect of running a business should be covered and zero assumptions should be made of the franc

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

Combination pro

isees existing knowledge. This might make the manual bulky but it is definitely the right way to go. The franchisees will come to regard the operator’s manual as his b

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

ble and if the franchisor has covered every aspect of running the business then this is more likely to lead to successful franchisees.

As the franchise network grows

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

the franchisor will have less time to spend to individual franchisees. Having more details in the operator’s manual will lead to less calls that have to be fielded by

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

he franchisor. It is imperative that when a franchisee does make a call and asks a question that is already covered in the manual that he is taken to the correct page

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

hilst on the phone. This will further reinforce in the franchisees mind the need to check the operator’s manual before making that call.

Every time a call is made whe

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

e the answer is not covered in the manual then it is time to update it. Over time this will lead to a comprehensive “bible” that covers most of the day to day question

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

Following aspects would a

s asked.

The manual should be broken down into at least two segments; the first segment should be purely for the franchisee and the second segment should be for the f

dd to the challenges in developing combination products:

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

anchisee and the staff employed in the franchisees business. This is important because often the franchisee will not want the staff to know everything about the busine

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

s. Some parts of the manual might cover aspects like how to deal with problem staff and disputes. Obviously this segment should only be for the franchisees benefit and

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

not for the staff employed in the business.

Great care should be taken to create a definite structure to the manual so that the information within can easily be foun

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

and understood. The addition of pictures, graphics and diagrams will enhance the manual and make it easier to understand.

Often if the manual is too bulky, it is eas

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

Professional from academic institutions, pharmaceutical industries, health care indust

er to have it in separate sections; examples of which could include: Administration, Marketing, Managing the Business etc. This will make it even easier to use.

The b

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

est way to provide updates to the franchisee is by having the manual loaded on a web page. A separate section should be created which just deals with regular updates.

.

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

his way the franchise can easily update his manual without having to print a new one every time certain pages are modified or improved.

A well designed operator’s man

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

Companies that provide selfless information through particip

al will lead to less headaches for the franchisor and ultimately to more successful franchisees. This in turn will lead to more enquiries for the franchise opportunity

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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