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When you make an investment – from a simple bank certificate of deposit to a large shopping mall – you are going to be buying from someone whose greatest skill is employing sales cl

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

osing techniques. Their skill in closing a sale will not include safeguarding your money or earning you any profit. And their number one priority is to make their sales quota to kee

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

Examples of combination products may in

p their job. It is only your personal education, experience and due diligence that can protect your money from the numerous people on the other side of the table.

It is a dilemma t

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

hat in order to invest, you’ll be face to face with professionals who do not have your financial interest at stake – but they will all appear to be. Sales people will appear to be o

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

n your side right up until the moment you write a check or sign a commitment. Then any problems are yours alone, their verbal promises go up in smoke, they stop returning your phone

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

Combination pro

calls and the fine print suddenly negates the possibility of getting a single dime back from your investment. In my experience, a salesperson’s top priority is never your best finan

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

cial interest, and you need to realize this no matter how friendly they are or how polished their sales pitch appears. As you walk into a bank or brokerage office, or call a broker,

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

you need to keep in mind that their personal goal is not in alignment with yours. To see past their sales routine, you need specific education, experience with the industry, and, h

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

opefully, a knowledgeable mentor.

For example, I once received a solicitation from a loan broker who wanted to get me into a triple-net lease commercial building with a million-dol

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

lar loan. After a few questions it was clear that he was acquainted with lending, but not very experienced. But continued questioning revealed that his knowledge of commercial real

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

state would barely fill a thimble. And he was the principal agent trying to slam me into a million-dollar loan so he could collect a commission check and move on to the next deal. A

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

Following aspects would a

lthough he sounded quite confident on the phone, his responses destroyed my trust in his ability to maneuver through the numerous issues and problems in my best interest. By studyin

dd to the challenges in developing combination products:

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

g an industry and talking to experienced players, you’ll be better able to ask questions with impact. And in this case, it was the difference between me keeping my money or locking

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

myself into a contract guaranteed to be a huge financial disaster.

To inoculate yourself against sales pitches, you need to do a lot of comparison shopping or at least become a sem

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

i-professional in the industry you want to invest in. Develop a healthy amount of suspicion and skepticism of any sales claim, and hire experienced professionals to assist you on yo

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

r side of the table. These would be attorneys, accountants, financial and operational experts that are being paid directly from you to assess every aspect of a complex transaction.

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

Professional from academic institutions, pharmaceutical industries, health care indust

He or she will support you in areas that you may be weak, and ask all of the confrontational questions that need to be addressed before you sign anything.

Due diligence acts as a b

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

arrier between your money and all the people that want some of it. I personally want Fort Knox around my money, so I make the effort to educate myself as to what is going on in the

.

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

areas that I want to invest in. I take some facts that are offered to me and verify them independently, and then I get more facts and continue the process until I feel comfortable e

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

Companies that provide selfless information through particip

nough with the people I am dealing with. If I depend upon the sales people to perform due diligence for me, it is no better than throwing money into the wind and hoping for the best

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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