Advice Pool - Self Improvement

Leadership is a lost art in my book. It is one of the most wrote about topics imaginable. Go on Amazon and there is a ton of books written about leadershi

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

p. I could write one maybe ‘Everything I know about leadership I learned in the Marine Corp’. It’s true, and I know a few things that have worked and a fe

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

Examples of combination products may in

that don’t in my thirty plus years leading people. The one thing I know for sure is that you have to engage the ‘whole’ person. Each one of us brings thr

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

e things to the party, our hands, our head and our heart. Let me explain.

For starters each one of us brings our hands; that is our skills to the job. If

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

we work at McDonalds they have pretty much idiot proofed their processes and the skill required is to show up. If you’re a builder you hire people with ca

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

Combination pro

pentry skills, a trucker then you hire truck driver skills and so on. For many leaders and organizations this is where their engagement of their workers s

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

ops. They hire skills and they get skills and that is that.

The next part of the person a leader can engage is the head. The head represents a person’s i

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

ntellect, their engagement to think and bring more to the job than skills. When I worked at Compaq Computer in the mid-nineties they hired a lot of intell

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

ctual people who brought their heads to work. But as leaders, do we engage their heads in their work or allow them to just be involved to the minimum?

Th

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

third and most important element a leader can engage is a person’s heart, their passion. This can’t be bought, it must be led. In the early days of Compa

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

, or any start up for that matter, the hearts of the people are engaged from the excitement of the start up. Great leaders keep the engagement of the hear

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

Following aspects would a

s because of their leadership, not because of the start up.

The three parts of the whole person must be engaged to get the most out of your organization.

dd to the challenges in developing combination products:

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

Think about Gandhi for instance. He inspired an entire country with his leadership although he never held an elected position. Gandhi’s leadership brought

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

down the British Empire and he never held an official position. Why, because he engaged the whole person, not just one or two of the parts. He led by exam

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

ple and people knew they were important to him.

In my days as a Marine sniper, two consecutive years in the Vietnam War, I found the very foundation of t

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

is concept. We were highly trained in marksmanship and that was our skill. We were highly trained in tactics, given incredible support troops and trusted

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

Professional from academic institutions, pharmaceutical industries, health care indust

o complete our missions. We were allowed and expected to use our intellect. Then we were part of an outfit with a strong and proud history, with outstandi

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

g leadership above us and while our country wasn’t behind us, our Corp was … we had passion.

Why did fifty percent of us volunteer for more time in count

.

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

y than required? It sure wasn’t because of the money; I think they paid me $290.00 a month with hazardous duty pay. No, it was because of our passion to s

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

Companies that provide selfless information through particip

rve the man next to us, our Corp and to be the best at what we did. Leaders engage the passion in their follows while engaging the whole person.

Ed Kugle

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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