Advice You - Business

Franchising companies must address consistency of the products they use both in the operation of the franchise and those are items whic

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

h they sell. The franchising company must address these issues in the original franchise agreements that each franchisee signs. If som

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

Examples of combination products may in

e franchisees by their paper napkins from one company and another franchisee trying to save money buys their paper napkins from another

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

company to save money; there might be a problem with the quality from one of the companies that the napkins are bought from. This can

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

cause customer complaints, quality control issues and presents a problem for all franchisees of the franchising system.

To prevent th

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

Combination pro

is from happening in my company I added a clause to our franchise agreements to address the issue of approved vendors, quality control

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

issues and consistency. Below is a copy of that clause in our franchise agreements;

4.6 Non-Proprietary Equipment and Supplies

Franc

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

isee will have the right to purchase equipment and supply items, other than Proprietary Products, for use in providing Services, from a

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

ny responsible source; provided, however, that Franchisor reserves the right to approve suppliers, equipment and supply items. Independ

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

ent suppliers will be approved by Franchisor if their products meet the reasonable quality standards established by Franchisor. In orde

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

r to obtain approval of any such proposed alternative equipment or supply item, Franchisee will provide Franchisor with documentation f

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

Following aspects would a

rom a source independent of Franchisee or the proposed supplier which demonstrates, to the reasonable satisfaction of Franchisor, that

dd to the challenges in developing combination products:

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

the proposed alternative equipment or supply item performs as well as the item to re replaced.

Nothwithstanding such documentation, Fr

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

anchisor will have the right to test further any such proposed equipment or supply item and Franchisor will be reimbursed by Franchisee

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

for the costs of testing such items. In addition, Franchisor reserves the right at any time to require substitution of newly developed

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

Proprietary Products for non-proprietary items, which would then be sold to Franchisee in accordance with Section 4.6. The sale by Fran

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

Professional from academic institutions, pharmaceutical industries, health care indust

chisor, if offered, of nonproprietary equipment and supplies to Franchisee shall include a commercially reasonable markup.

--- --- ---

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

- ---- --- ---

Every franchise company is well advised to maintain a strong approved vendor list of quality products that will be used

.

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

in the operation of the franchise. The franchise company needs to address this issue in the franchise agreements and seek expert lega

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

Companies that provide selfless information through particip

l advice from a franchise attorney who is a specialist with experience in the franchising field. I hope you will consider this in 2006

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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Over 90% of businesses employ anti-virus software, firewalls, physical security measures, and access control measures, yet over 55% of these organizations still have unauthorized use and detect intrusions on their systems. These statistics are alarming considering the average reported loss of propriety information from a breach in IT security is at $2.7 million per incident(1).

For those who think they can get a job in the medical billing industry just like one at a Burger King, this look at just some of what's involved should be a real eye opener. Medical billing is not just a job.

Change direction from internal to customer focus, functional to horizontal management and management-centeredness to total involvement.

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