Answers - Business

Just getting back from seven days at the Westin Hotel in Puerto Vallarta.

The purpose of this trip was to meet with my

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

mastermind group - Master Speakers International. We've been meeting four times a year for the last 10 years.

The ci

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

Examples of combination products may in

y was great and the hotel was good but it didn't rate a 12.5 score.

Let me explain:

Pedro - he gets the 12.5!

He was

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

the doorman. An extraordinary doorman. I couldn't help but notice all the little and positive things he did with his

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

ustomers. He gave new meaning to the words customer service.

From the neck down he had a body like Woody Allen - mayb

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

Combination pro

even smaller.

From the neck up he reminded me of Billy Crystal.

He was animated, energetic, and funny in a subtle wa

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

.

Last Wednesday, as Bernadette and I were going to dinner, a taxi pulled up and a 50 something guest greeted Pedro wi

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

h, "Pedro, I'm back and it's so good to see you again. I have a gift for you."

Pedro made you feel special when he wa

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

waving at you - as you are entering or leaving the hotel. It wasn't like a royal wave with a stiff outstretched palm

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

ith a rotating cupped hand.

No, when he waved his little fingers were fluttering like he was simultaneously playing th

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

piano and conducting a symphony.

He greeted everyone like a long lost friend.

I asked him, "Pedro, what makes you so

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

Following aspects would a

special to all of the guests at the hotel - everybody likes you so much?"

He responded with a great deal of humility.

dd to the challenges in developing combination products:

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

"I'm just a doorman," he said.

In a low-key way, which is hard for me to do, I repeated the question.

He said, "I ju

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

t want everybody to be happy and have fun when they're here at the Westin Hotel."

He was always smiling.

He always ha

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

a bounce to his step.

His eye contact was strong and focused on his guests.

He is a small man with a large presence.

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

His impact is powerful and memorable.

His job description probably says - doorman.

Even Pedro thinks he's just a doo

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

Professional from academic institutions, pharmaceutical industries, health care indust

man.

Pedro is not really a doorman, he's an Ambassador, for the Westin Hotel. In my book he rates a 12.5 on a 1-10 sc

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

le. He should be Director Of Customer Service.

I'm sending a copy of this to the CEO of the Westin hotels, and if he

.

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

as any sense he will give Pedro some recognition for his obviously outstanding job performance.

I also recommend a big

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

Companies that provide selfless information through particip

peso bonus for the hotel's premier Ambassador.

What are you doing to become the Ambassador role model for your company

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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ISO 9000 is a set of international standards that ensure product and service quality. In 1987, International Organization for Standardization (ISO) created the ISO 9000 standards providing guidelines to implement and operate quality management systems.

In a recent conversation with a young man who works in a restaurant, an all too familiar scenario was played out again. The young man recognized me as a frequent customer, and struck up a conversation that surprised me with the level of trust he had in confiding his situation. He said that he was trying to find a better job, because the place where he was working was low in pay and had no benefits. Unfortunately, he also stated that all the efforts he had recently tried in finding a better job were being thwarted by a negative reference from his current supervisor.

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Answers - Customer Service - On A 1-10 Scale It Was 12.5

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