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Where do you find the necessary funding to seed a business, buy a new one, or raise additional working capital? Traditionally, business owners have

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

used SBA loans, personal contacts, retirement distributions, credit cards or home equity to satisfy their funding needs. The biggest downside to t

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

Examples of combination products may in

hese sources of financing is the accrued debt and corresponding payments. They can pinch the business’s cash flow and impair the ability to access

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

money in the event that “life happens.” This is why the idea of using retire¬ment funds to inject cash into a business has been gaining popularity.

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

Although few know about this new concept, if structured correctly it allows for an individual’s retirement account to invest directly into their b

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

Combination pro

usiness venture without taking a distribution and paying taxes or penalties.

THE BACKGROUND

The IRA and 401(k) were created in 1974 when congress

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

passed the Employee Retirement Income Security Act (ERISA). The IRA and 401(k) trans¬ferred the responsibility of retirement investing from the em

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

loyer to the employee. The rules sur¬rounding these plans are complex; the laws state that retirement plans are prohibited from only two types of i

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

nvestments: life insurance and collect¬ibles.

NEW TREND IN FINANCING

Retirement Account Facilitators (RAFs), such as Bellevue, WA-based Guidant F

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

inancial Group, Inc. help structure specific retirement accounts that en¬able investment into private businesses.

“This investment strategy has be

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

en implemented for [more than] 15 years and has been legal since ERISA passed in 1974,” said Joe Wishcamper, gen¬eral counsel for Guidant Financial

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

Following aspects would a

Group.

This industry, bolstered by the stock market perfor¬mance of recent years, has been growing at a rapid pace as more entrepreneurs pursue o

dd to the challenges in developing combination products:

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

wing or financ¬ing their business this way. Wishcamper said that “last year [Guidant] structured retirement accounts for about 800 clients. This ye

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

ar [Guidant] will structure retirement accounts for more than 1500.”

The main reasons a business owner would want to turn to their retirement acco

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

nts for financing in¬clude the added advantages of less business debt and greater long-term potential for their retirement funds. By using retireme

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

nt money instead of a tra¬ditional business or home-equity loan, business owners can avoid costly debt service.

This enables more money to be rein

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

Professional from academic institutions, pharmaceutical industries, health care indust

vested into the business instead of sending cash to a bank each month in the form of interest payments. In addition, because the retirement account

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

owns a portion of the business, some of the profits from the business can be returned to the retirement account tax-de¬ferred.

If you are looking

.

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

for financing for your new or current business venture, your retirement account just might be the answer. Before proceeding with this type of inve

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

Companies that provide selfless information through particip

stment strategy it is important to understand all the benefits and risks involved when investing retirement dollars into your business or franchise

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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As a small business start-up coach, I get asked a lot of questions. The most frequent one: Where do I get start-up cash? If you are wondering the same thing, this article is for you. In it, you will learn about the differences between angel funding and venture capitalists, the value of taking out a loan, and considerations of taking on a silent or working partner.

Offset printing is a more efficient and refined operation in generating prints. It is also the most common and practical printing process used by commercial printers for it adequately meets the standards of a desirable print.

If you are looking to leave your old career or job behind to start up your own business, then you are already half way there. The idea of you having something more has already been planted in your head, now all you have to do is have the courage and determination to follow through on your business ownership goals.

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