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There are moments in life when someone says just a few magic words that become powerful beyond the speaker’s imagination.

Perhaps this has happened to you.

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

It has to me – twice.

The first magic moment occurred in 1972 when my high school science teacher, Stan Rhodes, challenged his students to see who could b

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

Examples of combination products may in

ild the strongest bridge using just a limited amount of balsa wood and glue.

On the day of the contest, a serious problem emerged. I knew the span of the b

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

ridge could be at least 12 inches, but I got the width wrong. I understood the maximum width was 1 inch. In fact, it was 1.5 inches.

While my design was go

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

d, my bridge was 33% thinner than all the others. Even so, it came in second place.

I was crushed. With an additional half-inch of width, I surely would ha

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

Combination pro

e won the contest.

As I was leaving, Mr. Rhodes pulled me aside and said, ‘Actually, your bridge had the best design. Well done.’

I looked up at him, my m

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

ood completely changed.

‘Really?’ I asked in surprise. ‘Do you think so?’

‘Absolutely,’ he grinned. ‘You are a very good designer.’

‘Thanks, Mr. Rhodes!’

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

I walked away triumphantly.

Today, more than two decades later, I make my living as an innovative curriculum designer. I’ve built bootcamps, orientation pr

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

ograms, international tours, interactive workshops, management retreats, conference games, video and web-based learning systems and more. I am confident and

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

passionate about the power of good design.

Stan Rhodes’ magic comment made a difference.

The second magic moment came when I was new to the business world

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

a recent graduate of my youthful years as a world-trotting citizen diplomat and Frisbee instructor.

I attended my first National Speakers Association Annu

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

Following aspects would a

al Convention. Nervous and inexperienced, I was under-dressed for the event and had no idea how successful speakers built their impressive careers.

By chan

dd to the challenges in developing combination products:

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

e I stood next to Thomas Winninger in the back of a large conference room. Thom and I are about the same height and for an instant we saw eye to eye. He int

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

roduced himself with enthusiasm – his trademark. I offered a more hesitant ‘Hello.’ We chatted for just a short while. I felt rather awkward.

A few moments

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

later, Thom looked right at me and spoke with an intensity that went to my core: ‘I can see you’ve got what it takes to succeed in this business. You’ll do

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

ell.’

It was a busy conference and Thom was very well known. We soon parted company in different directions. His comment, however, stayed with me.

Today,

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

Professional from academic institutions, pharmaceutical industries, health care indust

more than twenty years later, I enjoy my career as a successful professional speaker. Thom was right, I did have what it takes. I wonder how he saw it? Mayb

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

he figured that anyone who showed up at the Annual Convention had the interest and desire, if not yet the skills required.

Then again, perhaps Thom didn’t

.

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

see much potential at all, but spoke up to help me create it.

Thanks, Thom.

Key Learning Point

What you say to another person may impact the balance of

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

Companies that provide selfless information through particip

heir lives. Make the effort to boost their confidence, self-image and esteem.

Action Steps

Don’t hold back. Move other people forward. Say the magic words

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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