Just Other Articles

Have you ever noticed that just when you think you may have found a solution to a problem another problem emerges? Then when you fix that problem, you find yourself back to your original issue? Well perhaps you never had a problem that could be solved in the first place. You may have been dealing with a dilemma or a "polarity" that simply needed to be managed!

Dr. Barry Johnson has been working on th

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

e Polarity Management" Model and its set of principles since 1975 and this paper has been written to introduce you to some of these concepts. By definition a "problem" is an issue which requires a solution. The goal of a problem is to find a fix to the current situation and move forward to a new reality without being required to ever look back. However, a "polarity" is an issue that needs to be address

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

Examples of combination products may in

ed, but the "solution" is not one that can survive independently and will actually still require support from the original issue.

Let's look at an extremely basic polarity that we are all managing very well at this precise moment. This is the polarity of respiration that contains within itself 2 basic "problems". The first problem is the human body's need for oxygen. How do we fix this problem? We bre

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

athe in. But is that the "solution" to our problem? If it was we would just continue to breathe in and in and in. Once we breathe in though, our bodies transform that oxygen into carbon dioxide which our bodies dont like. So what can we do? We breathe out. Thus losing the oxygen that was the solution to our first problem. In fact, there was never a problem at all (remember a problem should possess a si

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

ngle and final solution), rather we had a polarity that needed to be managed and this was accomplished through breathing in AND out.

Let's look at another example that is becoming more and more prominent in the corporate environment, the switch to a team-based workplace and dynamic. Many companies now believe the solution to a majority of their work-based problems is a shift to a more team oriented wo

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

Combination pro

rkplace. Teams are being credited for their ability to: create a synergistic effect, provide a common direction, provide mutual support, appreciate every individual's job, and create a cohesive unit. If this is true for teams, than certainly a shift to a team oriented workplace must be the answer. The "problem" is solved. However, with teams aren't the following characteristics also created: too much c

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

onformity, bland sameness, too many meetings that last too long, the neglect of personal needs, and the organization only rising to the level of the lowest common denominator? Perhaps teams aren't the answer after all, because when you focus on the individual you get: individual creativity and initiative, an entrepreneurial spirit, fewer meetings and individual freedom. But if focusing on the individua

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

l is so good, then why was there a perceived problem in the first place? Perhaps because with an individual focus you get: people who feel isolated and left out, no common direction, rewards to only those who hit home runs, and no synergist effect or team support!

So what then is the answer? There is in fact no answer to be implemented, rather only a polarity to be managed. In this case the two polari

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

ties are the individual and the team. By recognizing these two polarities, organizations can understand and predict the downsides of either pole and strive to maintain a balance between the two positive sides of both poles. Leaders in organizations who understand the strength of managing polarities are more effective because:

- they save time and energy not trying to solve problems which are unsolvabl

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

e- they have a better understanding of the resistance they may face to organizational changes they wish to make- they will be more effective in negotiating with those in opposition to their changes- they may serve as more effective mediators- they will be able to anticipate and minimize problems that occur within a workplace when polarities are not managed well- decision making will improve when leader

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

s learn the power of the "and" and don't rely constantly on either/or decisions

Polarities are usually found at the heart of any form of major (or minor) organizational change and there are commonly two competing sides. Dr. Johnson has provided labels for each of these sides. The one side has identified problems with the status quo and has a vision for improvement and change. This side has been labele

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

Following aspects would a

d as the "Crusaders". The Crusaders are the ones who want to move from the downside of the present pole to the upside of the opposite pole. But standing as their opposition are the "Tradition Bearers". These are the people who still stand by the strengths of the organization which got that organization to the position it finds itself in today. They see the downside of the plans lobbied by the Crusaders

dd to the challenges in developing combination products:

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

and fear the potential negative outcomes of the proposed changes.

In a conflict such as this, who is right and who is wrong? Surprisingly, both sides are actually "right", the problem is that although they are right, they are also incomplete.

(Please note: an image is missing here. Please visit http://www.team-building-leadership.com/polarity_management.html to view the entire article and image)<

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

/i>

Consider the image above (many of you have probably already seen this and know what they're looking at). There are those who see a goblet and those who see two faces. Who is right and who is wrong? Of course both perspectives are correct, they are only incomplete. In Gestalt's theory, he named that which the subject focuses on as the "figure" and that which surrounds the figure and is out of focus

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

as the "ground". In our example above, the figure and the ground can switch properties depending on where the subject focuses his/her vision. But what is interesting is that it is not possible for the subject to see the entire picture (the faces AND the goblet) simultaneously. Rather, the focus must switch from one to the other for the subject to understand the complete picture. This is the crux and

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

the strength of polarity management. For a polarity to be managed successfully, focus must be removed from one side of the argument and attention given to the other while remembering the allowance for the focus to shift back to the original side. To often when people or organizations believe they are solving a problem, they are resistant to ever focus again on from where they came. However, if you onl

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

Professional from academic institutions, pharmaceutical industries, health care indust

y allow yourself to see the faces above, you'll never again be able to appreciate the entire picture! Interestingly, we must also accept that without the goblet the faces would also not exist.

Polarity Management can be a very powerful tool when used at the right place and time. The task is knowing when and where to use it. Polarity Management does not imply there are no problems to be solved because

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

there are. PM can only be used when the following conditions are met:

1) The difficulty must be ongoing.

2) The two poles must be interdependent.

Let's imagine you have an employee who is stealing from the company. Is this a polarity or a problem? If you were to fire or have this employee arrested, the problem would be solved and would no longer be ongoing. This is definitely not a polarity to manag

.

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. Now let's return to the individual versus team example. If your company is failing to maximize the synergy of your workgroups but individuals aren't receiving the recognition they feel they deserve, do you have a difficulty that is ongoing and two poles that are interdependent? Yes you do, and this is a polarity to be managed.

The goal of polarity management is not to solve or remove problems. Rath

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

Companies that provide selfless information through particip

er it is to identify the strengths and weaknesses of the two poles that exist within the dilemma. With this knowledge organization leaders can predict, prepare for and manage potential pitfalls within the organization. The object is not necessarily to eliminate all the negative aspects of either pole, but rather to maximize and sustain the potential of existing within the positive sides of either pole.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Just Other Articles - Polarity Management

Related Articles: