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Can you spot the difference? Let me give you a hint; it’s not the landscaping. It’s not the location. It’s not the gold pl

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

ated fixtures in the master bathroom. In fact, it’s not anything you’d ever notice with the naked eye. The $596,000 differ

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

Examples of combination products may in

nces are in how much the buyers unwittingly may pay for this home if they aren’t careful.

I recently met with a gentleman

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

who was referred to me by his financial advisor to receive some consulting on how to best structure his mortgage in prepa

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

ation for retirement. He wanted to retire in 13 years and he had refinanced his mortgage last year to a 15-year fixed rate

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

Combination pro

loan, taking advantage of the low rates, and wants to own his home free and clear right about the time he retires.

Most h

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

ome owners have the misconception that the wisest method to accelerate the pay-off of their home is to simply pay extra pr

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

ncipal payments to their mortgage by utilizing a 15-year mortgage, bi-weekly payments or even by adding an extra $100 each

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

monthly. In actuality, none of these methods usually proved to be the wisest method to accomplish a “free and clear” home.

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

You can accumulate sufficient cash in a conservative tax-deferred mortgage acceleration plan to pay off a home just as s

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

on or sooner than utilizing the methods described above. In addition you can accomplish the goal of paying off your home j

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

Following aspects would a

st as soon (typically in less than half the time) plus you will have the following advantages: 1) Maintain flexibility, li

dd to the challenges in developing combination products:

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

quidity and safety of principal by allowing the equity to grow in a separate side fund where it is accessible in case of e

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

ergency, temporary disability, or unemployment. 2) Maximize the only real tax-deductible interest allowed by tax reform by

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

keeping the loan balance as high as possible until you have the cash accumulated to pay off your home in a lump sum.

Let’

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 look at our example above…by strategically refinancing and taking advantage of the tax deductibility of mortgage interes

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

Professional from academic institutions, pharmaceutical industries, health care indust

we were able to accumulate enough money (at only 6% rate of return) to pay off the home in 8-1/2 years instead of 14 year

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

. If he continued to invest his monthly saving he would have $596,000 more than the balance his mortgage at the time he wa

.

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

s ready to retire. Don’t be fooled into giving up the liquidity, safety and potential rate of return on your money by givi

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

Companies that provide selfless information through particip

g it to your mortgage company. Get the facts and structure your mortgage to give you the greatest advantage from the start

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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