Useful Advices - Business

In today’s world time is very important, if not everything. Time to prepare, time to market, time to close, time to roll out, and many other time related events can determine in great part whether a franchise venture is successful or yesterdays news. Franchises have been

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

burdened, or perhaps mandated is a better choice of words, to comply with Uniform Franchise Offering Circular (“UFOC”) law for 25+ years. During this 25+ year period the UFOC has changed dramatically, and the legal bodies controlling its function and purpose have also cha

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

Examples of combination products may in

nged, but one thing has remained constant over these years, and that is UFOC’s are expensive.

They are very expensive to create, super expensive to produce and distribute, and unbelievably costly to store and audit. UFOC’s are one of the single greatest expenses new 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.

hises face, and for the first time there is a cheaper and more effective way to do business. It is legal, it is safe, it is secure, it is encouraged and it will make an existing franchise more efficient and lower the barrier to entry for new franchisers. This revolutionar

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

technology has only been around for 135 years, so it is about time the legislators let franchisers take advantage of the savings. What is this new technology you ask? It is electronic signature capturing, and New Hampshire was the first court system to rule on the validi

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

Combination pro

ty of electronic signatures in 1869, it was in relation to the telegraph and signing for invoices for goods shipped by railway cars, but it was and is legal, so why not use it in other forms of business?

In the 1980’s businesses and courts started to ask this same question

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

, and voil? there was the fax machine. The fax machine got the proverbial electronic signature ball rolling again in business, but the Internet will take it to its rightful level of use in business. Practically everyone has access to the Internet now. Public libraries, 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

chools, businesses and 100’s of millions of homes have Internet connectivity available to them on demand. The fax machine was certainly prevalent, but it could never have the wide spread use and functionality that the Internet offers, and therefore the Internet is the best

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

logical way to spread the use of electronic signatures.

Franchises may send their UFOC electronically to potential franchisees. They may do this by building internal delivery systems, or they may use external delivery services. The delivery method will depend on the size

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

and nature of the franchise, but the purpose will be the same, cut costs and reduce time to close business. Any franchise that is not actively looking for an electronic UFOC delivery service is going to be left behind. Electronic delivery will shorten sales cycles by all

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

owing franchises to start the 10 day waiting period immediately, and open up additional markets by reducing the cost of entry.

Franchisers that embrace electronic UFOC delivery will save money and time in multiple ways. Take a look at the following chart.

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

Following aspects would a

strong>Costs Associated with a 150 Page Paper UFOC’s

(1) 150 + Ink + Paper + Wear and Tear on printer = $3
(2) Binding = $1
(3) Outbound Overnight Shipping = $20
(4) Inbound Overnight Shipping = $20
(5) 150 Pag

dd to the challenges in developing combination products:

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

s 1 Year Storage Using Government Estimate = $19

(6) Labor @ 2 Hours for Total Process – Sending and Receiving = $40

(7) 2 Days Opportunity Time for Best Delivery Option = $Unknown

Total Cost of Using Paper = ($103.00)

<

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

strong>Costs Associated With Paperless UFOC Using Electronic Signatures

Labor @ 15 Minutes for Total Process = $5
Sending File Electronically = $5
Delivery Is Immediate = No Lost Opportunity Costs

Total Cos

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

t of a Paperless Transaction = ($10)

Total Savings Using Electronic Signatures vs. Paper = $93.00 per UFOC

The FTC has issued several Informal Staff Opinion Letters to electronic signature companies acknowledging that these service

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

s comply with the current FTC rules. PrivaSign.com, located at http://privasign.com/laws-cfr-ftc.asp is one of the companies that received such an opinion letter, and additional companies may be found at the http://www.ftc.gov website. By utilizing an electronic signature

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

Professional from academic institutions, pharmaceutical industries, health care indust

and UFOC delivery service, like PrivaSign, franchisers will save hundreds and potentially even thousands of dollars a month delivering their UFOC’s, and capturing new business.

Franchisers who are slow to adapt new electronic signature methods will undoubtedly lose busines

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

s to the faster and more aggressive franchises. Speed and timely delivery of materials will allow technology savvy franchisers to approach and win more business. In today’s franchise world prospects generally look at multiple franchisers before selecting which one is righ

.

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

t for them. Therefore the franchiser who has the fastest response time, and the first chance to earn a potential franchisees business is more than likely going to win.

Electronic UFOC distribution combined with an efficient electronic signature capture service is the righ

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

Companies that provide selfless information through particip

t choice for virtually every franchiser. Explore the market and try out different providers to discover which one is right for you. The cost savings, the time savings and the efficiency gained by using electronic signature technologies is worth the effort.

By:

Jason McKa

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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I finally arrived at Allentown, PA to attend a business school just a few days ago. The long drive from my home in Vermont wasn't too bad because the view was wonderful and relaxing. I arrived at the Allentown business school just in time to have a good weekend to explore before my classes started on Monday, although I would have liked to visit this city a little bit earlier in the month.

It's difficult to change a perception. If you gotta start changing, it should start at the top.

When a key performer decides to leave, it shouldn't be a surprise to you. Here's How To Stop The Surprises: Use this simple Employee Retention Risk Analysis process to prompt your managers to regularly assess the 'retention risk' of key performers, and report back to you regularly.

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