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Are you considering having a partner in your new business?

Often I find that my clients are looking to go into a business

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

partnership when starting their new business. Considering my market – new entrepreneurs it makes sense that this is happeni

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

Examples of combination products may in

g. After all new entrepreneurs having never been involved in a business partnership would be likely to try it out. On the s

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

rface it seems a fairly common occurrence and a generally accepted business practice. Underneath however you're mixing a vo

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

latile concoction. One life lesson I learned long ago is that until you know how someone is about money, you really don’t k

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

Combination pro

ow how that person is. Money has the ability to reflect the best and worst in people. We all know it but somehow when it co

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

es to partnerships of all kinds we all too often play people pleasers numbed by the novocaine of looking bad.

There are 3

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

types of potential partners one takes on in business. They are as follows.

• Friend
• Family Member
•

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

usiness Associate that has become a friend of sorts.

The most common reason one brings a business partner aboard is the wo

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

st reason to do so. The most common reason is to "share the fear". As a business coach I have found this to be the case nea

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

ly every time someone wanted to bring on a partner. Whether they knew it or not, they wanted what I call "a liability spong

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

Following aspects would a

e". The logical follow is that once the fear has worn thin, the partners begin to compare who is doing more or less than th

dd to the challenges in developing combination products:

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

other, who is taking more time off, who comes in late and the list goes on. The partnership begins to look like 70% of the

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

marriages – they begin to look really dysfunctional and often end in divorce. Unfortunately in most cases (or fortunately j

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

ust the same) there was no vow taken before God where the partners stated "til death do us part". There is only money holdi

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

g them together.

If you do bring a partner on, be comfortable knowing that you could lose them as a friend or family membe

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

Professional from academic institutions, pharmaceutical industries, health care indust

forever -- long before death does you part. For me, all the money in the world can’t replace certain relationships in my l

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

ife. Despite many temptations to mix business with pleasure I know better. I know better because I've done it and I've even

.

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

lost a couple of friends in the process. Here is the good news. If you are going to bring a partner aboard in your new or e

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

Companies that provide selfless information through particip

isting business my article to follow, Business Partnerships – Doing it Right, will help you make it as painless as possible

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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