Digg It - Business

In its simplest definition, a system is nothing more than an organized, planned, and predictable way of doing things.

For example when we ta

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

lk about "marketing systems" we don't mean a single piece of advertising or even several pieces. A marketing system is all of your marketing

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

Examples of combination products may in

efforts working together in a synergistic fashion with your other systems that provides the owner/manager with predictable results.

There ar

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

e 5 types of systems:

* Organizational & Administrative - the structure
* Procedural - "how we do things here"
* Marketing - "ho

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

w we sell here"
* Financials - "how we pay for it"
* Benchmarks - the way to check

With these 5 basic systems set up one can run

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

Combination pro

just about any business. Think of the power of that statement! With only the knowledge of 5 basic systems, you can successfully run virtuall

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

y any business.

Put that in your pipe and smoke it, Mr. Harvard Business Grad!

We're often asked, "I'm a one-man band, do I really need to

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

write systems?" That's entirely up to you. Suffice it to say if your customers like continuity (they do) and you enjoy your sanity (we hope y

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

ou do!) writing systems will help make even the smallest company run smoother and more profitable. Hey, it's better than watching TV, isn't i

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

t? Of course it is. There are few things in business that will directly affect the profitability of a company than by working more on it rath

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

r than in it. Especially when it comes to marketing, finances, and productivity.

Of course there's a little more to know about how these sys

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

Following aspects would a

tems work but basically it all boils down to only a handful of things:

* Organizing
* Knowing who does what
* Implementing succe

dd to the challenges in developing combination products:

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

ssful marketing (via testing)
* Knowing your numbers
* Training your staff
* Checking progress

I can hear you now - "So wh

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

ere do I start?"

Start with writing down the tasks that you do and assign these tasks to a Job Description. (we call them Positional Contrac

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

ts) Next you "tweak" your systems to make them better. There's no such thing as a perfect system so always look for ways to improve and work

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

smarter not harder.

If you have employees, enlist them to help write the systems. Who says you need to do all the work? Your employees, surp

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

Professional from academic institutions, pharmaceutical industries, health care indust

risingly, will most likely come up with some extremely good material. Just be careful they don't delegate or remove the necessary tasks they

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

dislike! Simply tell them that you're not giving them a license to do away with the things necessary that have made you successful - you're m

.

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

erely asking for their professional input to enhance their customer relationship and ultimately their future with your company.

In future ed

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

Companies that provide selfless information through particip

itions we'll dig more into the types of systems and how they directly affect various aspects of your business. In the meantime, happy writing

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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