Main Subject - Business

Perhaps the most common theme I’ve heard in working with business owners or managers is that they rarely have time to plan for the future. They are so busy with day to day tasks and responsibilities, just getting through their weekl

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

y “To Do” list or fighting fires consumes all their time and energy, and then some.

Business owners often tell us that effective marketing strategies are not in place. Why? Because they are too busy selling. New products and serv

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

Examples of combination products may in

ces are not being developed. Why? Because they are involved in the delivery of existing products and services. Long-term planning is not addressed. Why? Because they are so busy working on this week’s “To Do” list.

The solution

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

to these scenarios is to distinguish long term functions from short term functions. This doesn’t mean deciding which tasks you will do today and which you will do at some point in the future. It means knowing which functions make t

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

he business healthy in the short term, and which functions make the business healthy in the long term. It’s not that one is more important than the other – you have to do both well.

The inevitable reality is that short term functio

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

Combination pro

s always crowd out long term functions. For example, let’s say I’m in the technology business and provide both “break and fix” work as well as installation of complicated networking systems. You hire me to develop a networked syste

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

for your business, which will take some time, some thought, some development. I’m about to begin this project for you when another customer calls and says, “My computer is down and I can’t work until it’s fixed.” Of course I rush

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

off to handle that customer’s short-term need at the expense of my long-term project with you.

Situations like this happen every day in every business. It’s common for a business owner or manager to handle both marketing and sales

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

or her business. You know you need to sit down and develop a marketing strategy for the next quarter, but cash flow is tight so you also know you’d better get out there and sell something. Short term versus long term again.

The si

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

gle most helpful action you can take to have the greatest impact on your business is to understand long term and short term functions, then separate them. Let’s take a look at examples of both short term and long term functions:

SHO

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

T TERM (if you do these well, your business will be healthy short term): - Accounting; - Administration (systems, procedures, policies); - Sales; - Operations; - Production; - Personnel (payroll, benefits administration).

LONG TERM

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

Following aspects would a

FUNCTIONS (if you do these well, your business will be healthy long term): - Marketing (anticipating the market & future customer needs; innovation); - Research and Development; - Finance; - Staff development & training; - Corporate

dd to the challenges in developing combination products:

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

culture, teamwork.

The second step is to begin separating those functions for yourself and your employees, realigning responsibilities. Take a look at all the roles you play in your business. Do you have responsibility for both lo

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

g-term and short-term functions? For example, are you handling both marketing and sales? Or handling both finance and accounting? Many business owners are spread all over the map.

Now look at the responsibility of each employee a

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

nd ask the same question. Are they responsible for both short term and long term functions? I’m willing to bet that if they are, the long term functions consistently fall lower on the priority list.

The best case scenario is to ha

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

e different people responsible for long and short term functions, as much as possible. Consider how to realign responsibilities so that certain employees are working primarily on long term functions and others are responsible for sh

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

Professional from academic institutions, pharmaceutical industries, health care indust

rt term functions. You may not need to hire anyone new, simply realign who is doing what.

In many businesses with a small staff, complete separation is unrealistic. The next best scenario is to be very aware that you are wearing t

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

wo different hats, and specifically allocate certain days or even hours to making sure your long term functions are given enough time and attention. For example, if you are handling both marketing and sales, you might block out two

.

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

ntire days each week where you do not schedule sales appointments, but you work on marketing instead. Or perhaps it works better for you to divide your days into morning for sales, afternoons for marketing. It takes discipline, and

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

Companies that provide selfless information through particip

it’s worth it.

Once you have the awareness, you’ll see your business through different eyes. Separating long term and short term functions is the most effective move you can make to help you grow your business.

© 2004 Darcie Harri

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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Tax attorney explains what to look for before hiring a tax attorney to help with IRS tax disputes and negotiations. A must read for taxpayers with IRS tax troubles or for anyone who knows of others with IRS tax problems.

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Late last year I was presenting a workshop for the senior managers of a major organisation. Whilst doing a pre-workshop survey to assess the challenges these managers were experiencing it became very...

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