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I have a friend named Owen, who I recently worked with to find him a new career in the restaurant industry. I am a restaurant

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

management recruiter, but more importantly, a career coach and a developer of interviewing talent. I worked with him in my pas

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

Examples of combination products may in

t life as a restaurant manager, so I knew what his accomplishments and strengths were and how he could improve a team. I also

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

knew that he was going to be one of the most challenging candidates I would ever work with!

You see the problem with Owen was

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

his inability to grasp his own assessment of his career and past experiences. He was a great manager and a solid leader, but h

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

Combination pro

e absolutely had no understanding of his abilities and how to market them to a prospective employer. He was in a dead end job

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

with no potential growth or upside, but he soldiered on everyday thinking it would get better or at least it couldn’t get any w

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

rse. I knew I had to break him of these cancerous thoughts and replace that negative mental attitude he had associated with hi

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

mself and his contributions. Because of the negative reinforcement by his direct supervisors and the illusions of the company

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

president, he would see himself as someone lucky to work for the company.

Now let me tell you that I was mind washed into thin

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

king the same thoughts about myself until I broke free from their grasp last year. I knew exactly what he was going through an

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

Following aspects would a

d I was determined to release my old friend from his prison, but I knew it would take work.

As I put myself in the hiring mana

dd to the challenges in developing combination products:

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

gers shoes and interviewed Owen, it became clear that here was an awesome manager and a very capable person who could do anythi

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

ng he wanted to- that is as long as it was talking me out of hiring him. He gave me every reason in the book to pass over him

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

s a potential candidate. He sold himself short on every question by focusing on what he hadn’t done, instead of marketing all

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

he had achieved.

This is a very common thing for people in bad situations. They believe to think subconsciously that somehow

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

Professional from academic institutions, pharmaceutical industries, health care indust

they deserve the place they’re at and they are directly responsible. This thought couldn’t be farther from the truth. Bad thi

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

ngs happen to good people and it is up to those people to realize that they can change their environment if and only if they re

.

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

ally want to.

By embracing a positive mental attitude and a can do mentality, anything they desire can be achieved. It won’t

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

Companies that provide selfless information through particip

be easy and it will take time to formulate a plan of attacking those goals, but it can be done.

Ask yourself…are you like Owen

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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