Advice You - Business

My daughter Katie recently got married. Something dawned on me as the planning wound down and the big day finally arrived. (Actually, two things dawned on me. One was the almost machine-like efficiency with which this extravaganza reduced our bank account balance. But that’s not what I’m writi

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

ng about now.)

Here’s what I noticed: Everything came off exactly as planned.

Before you say, “So what?”, consider … There were dozens of people involved and hundreds of details to manage. Tuxedoes. Dresses. Photographers. Videos. Down-payments. A cake. A reception hall. Invitations. More do

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

Examples of combination products may in

wn-payments. Decorations. The church. The vows. Bridesmaids. Groomsmen. You get the idea - the list goes on and on.

It was a truly impressive display of planning your work and working your plan. Here’s what I saw:

It started with my daughter’s personal vision for her perfect

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

wedding. (A long-range vision.)

Then, she started making lists and putting her thoughts down on paper. (Establishing goals and written plans.)

This, in turn, led to Katie asking various people (including me, but especially my wife Joyce) to h

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

andle assorted aspects of the operation. (Delegating - Assigning specific tasks to specific people with specific timeframes and outcomes.)

Katie followed up with the people involved and on the planned activities to ensure all was proceeding as expected. (Using

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

Combination pro

Key Performance Indicators to measure progress and success.) I saw a potential lesson for small business owners. What if a small business owner planned and managed his or her business this way? Now, I know that this is not a perfect analogy. A wedding is a one-time event, a

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

d a business runs continuously. I understand that. But isn’t there something to be gleaned from such an example? For the most part, entrepreneurs know what needs to be done. The shortcoming isn’t in the knowing; it’s in the doing (or not doing.)

Suppose Katie had established

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

her vision, and maybe even went so far as to develop written goals and plans, and then dropped the ball. No follow-through. No delegation. No execution. The results would be predictable.

Instead, she was passionate about her vision, was focused on her goals like a laser beam, and was committ

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

ed to executing her plans.

And so, I ask again: What if a small business owner planned and managed his or her business this way?

Back to “knowing and doing” … Let’s assume that you know what you want to accomplish and you know what needs to be done to get there. You’ve got the “knowing” part

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

squared away.

Turning “knowing” into “doing” starts with a plan. Many business owners get tripped up at this stage. We entrepreneurs are natural optimists, and as a group we have no shortage of self-confidence. As a result, we sometimes tend to anticipate unrealistic outcomes. I frequently se

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

e small business owners whose to-do list would choke a horse. A relatively short list of major initiatives is plenty for anyone’s annual plan. Better to set optimistic yet realistic goals and achieve them than to set yourself up for disappointment by expecting too much.

So a plan is written a

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

Following aspects would a

nd now it’s time to execute. Now what?

In my daughter’s case, she still had to deal with the ordinary, day-to-day stuff ... her job, socializing, paying her bills, time with family, time with her fianc?, errands, and so on. Yet, because she was passionate about her vision, was focused on her

dd to the challenges in developing combination products:

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

oals like a laser beam, and was committed to executing her plans, she pushed through the clutter. Pushed through the distractions. Pushed through the interruptions. Discipline allowed her to turn her vision into reality. (I’m a down to earth, nuts-and-bolts guy, so I don’t want to sound too mu

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

shy, but I believe that your level of discipline is directly proportionate to your level of passion.)

She did much of the work herself, but she also delegated much of it to my wife and to others. For many business owners, one of the following scenarios comes into play. See if you can see your

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

self in any of these:

Nobody can do it as well as I can. Therefore, I may as well do it myself.
By the time I show someone else how to do it, I can go ahead and do it myself.
I don’t trust my employees with the information they need to handle this task, so I’ll do it

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

myself to guard the information.

I try delegating to my employees, but I just can’t let go. I’m there micro-managing every step of the way. So I’m 100% wrapped up in all the details, and no time is saved.

Learning to delegate effectively is a critical skill. It was a big par

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

Professional from academic institutions, pharmaceutical industries, health care indust

t of this event’s success. Fail to delegate and your enterprise will suffer. Finally, as time passed my daughter followed up with the various players to ensure that tasks were accomplished as planned. When needed, plans were adjusted and corrective action was taken. You can do the same in your

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

business. Use your passion for your vision to muster up the discipline needed. Set optimistic yet realistic goals, develop written plans, and then focus on them like a laser beam. Commit to executing your plans, and don’t allow yourself to be stopped by day-to-day distractions. Delegate. Meas

.

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

re your progress and make adjustments as needed.

Here’s my challenge to you: Make next year your break-through year. Despite past set-backs. Despite previous lack of discipline. Despite prior lack of progress. Give it your all – your best effort – for one year, and see what it does for your b

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

Companies that provide selfless information through particip

usiness.

I’ve seen first-hand the dramatic changes that can take place in a small business in one short year. Next year can be the launching pad for your future success. It can give you the confidence and the momentum (and the cash) to build upon for years to come. Make it your best year ever

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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Product development may be defined as the process of conceptualizing and marketing a product. And this product can be something new to the market or something new to an individual company, or it could be a product which already exists and has just undergone improvement.

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