Advice You - Business

I don't wear eye glasses, at least not yet. Even though I don't wear them, I still understand how glasses affect your sight. I will occasionally put some on, just to see how strange it looks through them. In my case, what I

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

see is all distorted and blurry, but if you talk to people about when they first begin to wear glasses they smile and talk about how clear things became for them once they put on those glasses.

Our eye sight changes gradual

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

Examples of combination products may in

ly and our eyes are able to compensate for some time. We begin to accept things being blurry in the distance; thinking that is the natural way for things that are far away. We begin to accept those changes as natural and ok.

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

Suddenly, something happens and we come to a realization we can’t see and that maybe we need glasses! After this epiphany, the glasses give us a brand new view instantly – providing us with a new and clearer picture of the

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

world around us.

Our mental perspective is much like our eyesight. Without new glasses to help us see the world in new ways, we can gradually lose our focus, take things for granted or just assume we know how things are, ev

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

Combination pro

en if they are blurry.

We don’t always think about it, but we always benefit from a fresh perspective. A fresh perspective can get us out of our comfort zone, kick start our thinking, put us on the road to improvement, and

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

help us find better solutions to problems. Here are five ways you (or your group or team) can gain the benefits of a new perspective without going to the optometrist.

1. Examine your assumptions. Assumptions get in our way

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

all the time. A large part of the humor on television comes from assumptions that one party makes that are erogenous. Because we can “see” the assumptions, it makes us laugh. Strive to reduce the role assumptions play in you

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

r life. When looking at a new problem or challenge, make a list of all of the assumptions in the system; yours, the team’s, the organization’s, the industry’s, the Customer’s, whoever! Once we understand the assumptions we w

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

ill understand other peoples’ behavior better and have a new perspective on the situation (and quite possibly find a great solution).

2. Read new things. If we only read the same things in the same magazines and newspapers

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

we risk blurring our vision. Go to your bookstore, newsstand or library and pick up three magazines you have never heard of, or borrow the magazines of your neighbor’s 14 year old. Then read them cover to cover. Read them wi

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

Following aspects would a

th curiosity, and keep your latest projects and challenges in mind as you read. Ask yourself as you read how you can apply these fresh perspectives to your situation and interests.

3. Visit new places and do new things. If

dd to the challenges in developing combination products:

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

you want a new perspective, go someplace different! A new restaurant, a new vacation spot, a different parking lot. Take the stairs up those five flights. Go ice fishing or inner-tubing behind a ski boat. New ideas will spaw

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

n from the new places and experiences.

4. Seek out differing opinions. Before finalizing your decisions, ask for divergent views. Ask a grandmother, someone in accounting, or your neighbor. Ask an eight year old or your bes

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

friend’s spouse. Ask them, expect to learn something and really listen. Asking for these opinions will give you new viewpoints, leading you to think, “Hmmm.. I never thought about it that way” which is the goal of trying on

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

all of these mental glasses anyway.

5. Look at this site. One of my favorite ways to get people to think of old things in new ways is to show them a Peters Projection World Map. We have all grown up looking at the world th

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

Professional from academic institutions, pharmaceutical industries, health care indust

rough the lenses of the Mercator map. We know what the world, countries, and continents look like from this view. The Mercator map was developed for navigators, and so the straight lines match up with a compass. The problem

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

is that this view distorts the relative size of things – because the world isn’t flat! With a spherical world and flat maps we depict both accurate size and shape on one map. I could talk more about this, but to help you “se

.

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

e” this new perspective, go to http://petersmap.com and read and see for yourself. It will be time well spent. (I dare you not to want to share this with someone else within five minutes of learning more about this map).

Ev

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

Companies that provide selfless information through particip

en if your eyes are good you should have them checked every couple of years. Don’t wait nearly that long between uses of these glasses! Each of these approaches offers you a new view each time you use them, so use them often

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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We now live in a world where just about individual wants everything that they use or do to be as easy as it could possibly be. That is one of the reasons why digital mass flow controllers are popular mass flow control products that are used in a wide variety of industries. Although digital mass control products are often considered the most popular they are not the only products currently available on the market.

Do you often do so many things behind the scenes that your customers have no idea how hard you're working for them? Do they know the expertise it takes to get the job done right - or do they think they can do just as good a job as you can, without any education or training at all? Let's do a few things to make it clear to our clients exactly how much value we bring to the table.

You won't hear much about productivity on the news because it usually comes from small improvements. But millions and millions of small improvements occur every year. And collectively, they have revolutionized the way we work and live.

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