Advice You - Business

“Ha!” you say. “For someone to make a statement like that, they obviously haven’t worked in the real world and certainly have never had to run a company.” Well, let me assure you. In my past I’ve not only run companies, but spent many years in one of the most notorious industries f

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

or turnover – the restaurant industry.

Don’t get me wrong, I understand and appreciate the challenges that turnover creates. Turnover causes a drop in productivity, lower profits, inconsistent quality, and certainly creates work overload. In addition, turnover results in a lack of

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

Examples of combination products may in

motivation, a lack of enthusiasm, apathy, and a lack of teamwork. But here’s the question…

Are the challenges I just raised problems or symptoms? In the context of our discussion of turnover, most people would agree that they’re all symptoms of our turnover challenge. Turnover cau

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

sed each of these shortfalls, which leads us to the core question:

Is turnover a problem or a symptom?

Turnover is a symptom.

But what is turnover a symptom of? You may argue that turnover is a symptom of a weak workforce – unmotivated people, apathetic, too small of a labor pool,

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

etc. I believe, however, that turnover is caused by other factors. Turnover is related to leadership. Turnover is a symptom of leadership problems. Some of these leadership-related problems are: lack of purpose, lack of integrity, absence of a plan for developing people, poor com

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

Combination pro

munications, and treating people as objects instead of people.

Let’s discuss whether these factors really do cause turnover. I always suggest that clients use their own experience as their best example. Have you ever worked for a company just to earn a living? A job where you rea

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

lly didn’t care about the work or the company? I’d guess that virtually everyone has been in that situation at one time or another. You may even be in that situation right now. When you were in that job, were you on the lookout for a better opportunity? Did you leave the company t

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 take a job just to make more money? (… and then repeat the whole scenario once more?) When a company and a job lack purpose, turnover occurs.

Have you ever worked for someone who lacked integrity? Someone who would say one thing and do another? Someone who promised to do somethi

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

ng but never did? Someone who took the credit and placed the blame? Unfortunately, I’d have to guess that each of us has had that kind of boss at one time or another. When you were in that situation, did you continue to do your work? Of course you did. Was your work accurate 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

correct? Of course it was. Did you take the initiative on new projects for the benefit of the company? Maybe not. Go the extra mile to make a difference? Hmmm… Did you leave the company at the first opportunity? Point made. When an individual or company lacks integrity, turno

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

er occurs.

Ever work in a company where the prospects of advancement or expansion of responsibilities were nonexistent? Someplace where you knew that you weren’t going anywhere? Stay very long? That’s my point. Without an opportunity for growth, learning, expansion of responsibili

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

Following aspects would a

ty, and increase in personal value, people leave. When people aren’t developed, turnover takes place.

Have you ever worked in a company where major changes were “sprung” on you like a surprise attack? Where work was assigned to you and after you completed it, you found out you had

dd to the challenges in developing combination products:

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

done the wrong thing? What happens when people don’t communicate effectively? Poor communication leads to misunderstandings, conflict, de-motivation, and stress. What do misunderstanding, conflict, de-motivation and stress lead to? You got it – turnover.

And then comes the most i

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

nsidious issue of them all - treating people as objects rather than people. The truth is that from time to time we all fall into this trap to one degree or another. I’m talking about how we regard people. Again, use your own experience as your best example. Have you ever had someo

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

ne say something kind or positive to you, but you sensed that they were being “phony”? They used the right words, but you could tell their words were insincere? Did you believe the words or your sense of the person? No questions about it – we believe our sense of things and people.

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

When we are faced with someone who says one thing but means another, does our respect for that person increase, decrease or stay the same? Clearly it decreases. Not only do we rely on our sense of the person – our intuition – but we form opinions about them based on our insights.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Have you ever worked for someone who you lost respect for? Did you stay at that job very long? When people treat other people as objects, turnover occurs.

Purpose, integrity, developing people, effective communications, and regarding people as people are all leadership issues. Ex

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

ceptional leadership inspires the best effort in others, and when people give their best effort, the result is a high performance organization.

When you and your organization have a clearly defined Purpose, you attract and retain the talent you need. When you and your organization h

.

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

ave integrity, you build trust and loyalty. When you and your organization are committed to developing people, people become the best they can be. When you and your organization communicate effectively, conflict and tension diminish and cooperation increases. When you and your orga

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

Companies that provide selfless information through particip

nization work to treat people as people, they appreciate it and reciprocate.

Turnover isn’t a problem - it’s a symptom caused by leadership problems. Fortunately, the problems can be solved, and you have the power to make that difference. Strive to become the best leader you can be

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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Both Liquid Paper and Snugli were invented by moms as new solutions to old problems. Leveraging their ideas into successful products took different paths. Be smart about that business you’re cooking up at home.

When someone offers you a job you need to stop telling them why you deserve it and start thinking about how to make the situation work to your advantage. When an offer is presented, for the first time in the interview process, the candidate has the power.

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