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As an author and professional speaker, I often meet audience members or readers who point out something so insanely obvious; I wonder how in the heck I missed it.

Ah, the wisdom of curbside observers.

Switzerland. S

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

ummer of ’05. I was hosting a workshop at a youth leadership conference. We’d just started our program, so I was only beginning to tell the teenagers about the various reactions I observed in the first few years of w

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

Examples of combination products may in

earing my nametag 24-7.

Suddenly, the hand of an enthusiastic staff member shot up.

“Yes sir,” I said.

“Well, it’s not really a question, but more of a comment,” the man explained.

Forty highschoolers turned their

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

eads towards the back of the room as he said, “You know why I like this whole nametag idea? Because it’s like you’re giving people PERMISSION to talk to you.”

The room fell silent.

Wow. Five years I’d been wearing

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

a nametag 24-7, and that word never occurred to me. Permission. I liked it! And in the next few days, I realized why the word PERMISSION was so essential to approachability and communication.

Problems Esc

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

Combination pro

late without Permission
Some people would rather jump off a cliff than talk to a stranger. They’re shy, introverted, scared, uncertain, don’t know what to say and have a fear of being judged by others. So, t

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

his means they will not approach you, or feel comfortable being approached by you, unless permission is granted.

The easiest way to give permission is to smile. It’s the simplest front porch known to man. According

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

o Irving Goffman, the father of social psychology, “a smile is the number one indicator that conversation is desirable.” And it might sound incredibly obvious, but you’d be amazed how many people don’t understand the

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

value of smiling as it pertains to giving permission.

Like my old boss, David, the Front of the House Manager at a hotel where I used to work. He was one of those ex-military types that stared people down with his ee

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

ie green eyes until they ultimately averted their gaze and allowed him to take control of the conversation. And I swear to God, he never smiled. You could crack the funniest joke in the world, and, NOTHING!

I’m not

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

even sure if he had teeth.

Anyway, because David didn’t smile, he wasn’t giving his staff permission to talk to him. Because he wasn’t giving permission, he wasn’t approachable. And as a result, our team lacked open

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

Following aspects would a

, effective communication. For example, I once had a problem with my hours, namely that I was working 54 of them in one week as a part time employee! But I never felt comfortable coming to David with my problem becau

dd to the challenges in developing combination products:

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

e he was just THAT unapproachable. My thought was: I’d rather suck it up and work overtime than have a conversation with this jerk. That’s how unapproachable he was.

But that only made things worse. And as the prob

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

lem remained hidden from my immediate manager, it escalated. I ended up working eight out of the next nine days in a row (remember, I was a part timer!) and ultimately became so upset that I just lost it. That ultima

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

ely resulted in my resignation from the position.

Because he never gave me permission to approach him.

Signals of Permission
Here are some other ways to give the people around you permission to approach y

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

ou:

*Make eye contact and greet everybody, even the people you don’t know *Use adequate pauses in your conversation so people feel comfortable chiming in
*As you exit conversations or meeting, remind people that

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

Professional from academic institutions, pharmaceutical industries, health care indust

they can still come to you at any time in the future with related questions or ideas
*Keep your office door open to make yourself physically available, or if not, post your schedule outside the door
*Even if

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

you’re freezing your butt off, don’t cross your arms
*Use the word “permission” in conversations to deliberately remind people that they can feel comfortable approaching you

Ultimately, these interactions are abo

.

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

t opportunity: opportunity to hear what’s really going on with your staff; opportunity to really get to know someone; opportunity to show your people that you’re really willing to listen to their ideas and problems. S

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

Companies that provide selfless information through particip

o, think about ways you can grant permission to the people around you. Because if you want your staff to feel comfortable and confident stepping onto your front porch, you’ve got to give them permission to talk to you

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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One sure fired way to increase revenues without damaging your reputation, is to educate your customers into your price increase first before doing it. You don't want to be worried about raising your prices. Most people are afraid to raise their prices.

You need to stand out from the herd when it comes to business. You need to be better, stronger and more adaptable than your competitors. You need to be eye-catching, fresh and hard to pass by. And if you have a brand you have an immediate advantage because you have a backbone, or a frame work, on which to hang your products.

To survive, a company must satisfy different groups, refereed as stakeholders. These include stockholders, employees, customers, and society at large. In the short term, the aims of these groups conflict.

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