Advice You - Business

Many entrepreneurs have worked their way into a box.

They started a businesses to provide freedom, but in reality wha

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

t they have is job plus financial risk. They have placed themselves at the center of their business universe, and alth

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

Examples of combination products may in

ugh in theory they can take all the time off they want – they can’t ever. On top of that, if they want to increase the

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

r income it usually means working harder. In fact, many are afraid to grow their businesses at all, because they think

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

it will mean more work and more stress. And it will!

The added revenue just isn’t worth it to them.

Now these same e

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

Combination pro

trepreneurs (and you may be one of them) think the way out is to create some form of “passive income.”

What they mean

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

by this is income based on a product you create once and then earn money from forever – or at least a long time – with

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

out having to do much – or any – additional work. The fantasy is to sit on the beach, sipping margaritas, while the mo

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

ey rolls in.

Well let me tell you – without solid systems, there ain’t no such thing.

Unless they are totally digita

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

, passive income streams require logistics and fulfillment, creation, upkeep and production, just like any other busin

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

ss.

Without good systems, delegation and outsourcing - passive income is far from passive. And without a strong sense

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

Following aspects would a

of personal focus and a concept of your own highest-and-best-use, passive income can end up taking 20 hours a day. Or

dd to the challenges in developing combination products:

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

ore. Forget about sitting on the beach...

Of course, it’s not all bad news. What we call passive income should really

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

be called renewable income. BUT WITHOUT GOOD SYSTEMS – it will still be a ton of work.

So here’s the good news: stron

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

g systems can transform the myth of passive income into reality.

Can you see all the various steps that go into “pass

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

ve income?” And that’s without addressing the joint ventures, email writing, speaking, offline PR, and networking that

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

Professional from academic institutions, pharmaceutical industries, health care indust

go into marketing a successful passive income stream.

Hey – passive, it isn’t. It’s a myth. It takes tons of work. An

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

if you go the systems route, THAT takes a ton of work.

So is it worth it?

Absolutely. Because if you approach it pr

.

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

perly, most of the work is front loaded. In my case I get to build a portfolio of products which can create revenue fo

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

Companies that provide selfless information through particip

years to come, and in the process serve thousands more people than I could one company at a time. But it sure is work

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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Advice You - Seeking Passive Income

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