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The reason for any professional or trade association to exist is for the purpose of synergistic and mutual improvement of the persons and organizations involved is a particular industry or profession. I believe an association to be a gathering of people with similar interests and goals. This gathering must be a multi-faceted partneri

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

ng alliance between members (including associate or supplier members), officers and paid staff.

In every association with which I currently hold membership or have held membership, I've have experienced a class structure. While I believe this class structure is generally unintentional, it is none-the-less destructive and at cross-pu

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

Examples of combination products may in

poses to the associations’ stated mission. The officers usually make policy and the rules for all to follow. The staff works hard to serve the officers, more so than the membership. This is because they believe, or have the perception, that they hold their jobs at the pleasure of the board of directors. While operational staff genera

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

lly works under, and is hired by, an executive director or executive vice president, the staff people see their jobs as being at risk when they inform board members on things the board members do not want to hear.

Elected officers try to do their best to run the association so it will best serve the membership, but they must also ru

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

their own business. Some of the challenges that frequently occur are:

Individuals seeing the world through his or her own filter or paradigm. This can cause people to only see what they want or to only see the world through their situation. If one selects to participate as an association leader, this is a luxury one cannot afford.

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

Combination pro

The ability officers have to pork barrel can drive a wedge through any industry, especially between the buyers and sellers in the industry. The association must create value for all dues paying members, regardless of their status.

Elitism, planned or inadvertently occurring. This is the most insidious of value dismantlers. While it

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

is human nature for offers that select to donate an unusually huge number of hours to socialize with one another at meetings and events, there still is a responsibility for officers to individually reach out to the general membership. Additionally, those same people that donate the hours sometimes feel entitled. Entitled to what you

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

ay ask? The list is limitless; from questionable association resource spending to policy making that only serves the selected few.

Participation burnout of officers is common. People that care about the success of their association and industry as a whole, can acquire the Savior Complex, thinking that the entire industry will stop i

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

they don’t do it all. Then they get bitter about the time they feel obligated to donate.

Personal ownership disassembling synergistic results. When certain "entitled" people believe they own the association more than others, based on their personal standards of participation and history with the association, they can unknowingly pu

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

sh others away.

Over the past decade I have been helping organizations to see the world through the window of others. The system I offer is that of Total Organizational Partnering System (TOPS). Many associations in which I have come in contact have or could benefit from TOPS. The decision to adopt the multi-faceted partnering model

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

is not always easy. It is unfortunate that many associations are encumbered with persons flexing their personal and sometimes hidden agendas.

Is it possible in association life to have cooperation? Absolutely, I see it frequently. Working with others for a mutually beneficial solution is what should be at the foundation of any assoc

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

Following aspects would a

ation. Partnering is the redeemer necessary to successfully carry an association to new heights of success in serving its industry.

Today, many associations are faced with the fallout of consolidations within their industry; both regular members and associate or allied supplier members. In some situations, in order to survive and se

dd to the challenges in developing combination products:

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

rve their membership, even associations have found it necessary to merge. There will always be the members that support their association, regardless of the value they believe they receive. And, there will always be the people in an industry that do not believe it is worth their time or money to belong to their industry association.

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

What every association (staff, boards and members) must explore is the middle mass. These are the industry players that will only belong to, and participate in, their industry association if they believe they can get more out than they put in. This is possible through collaborative synergies developed through TOPS. Association leader

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

must partner with this critical mass in order to have the number and financial support to do the work necessary to keep their industry alive, healthy and growing.

Never allow the situation to develop in which members or potential members say, "I want to be part of the system. I want a piece of the pie, but I don’t believe it’s poss

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

ible.” Be cautious not to treat less participative members as second-class citizens. I know there is some truth to this because I, myself, have felt like a second-class association member in times past. Was I really a second-class member or was it just in my mind? Since my perception is my only reality, what do you think? Does it mat

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

Professional from academic institutions, pharmaceutical industries, health care indust

er what others think? No, because my perception is my reality, and it is for your members too.

Members, retained and new alike, are the lifeblood of any association. If you are an officer and keep that in mind daily, your association will not only survive but it will prosper. Listed below, are ten of my partnering principles that I

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

elieve association officers, staff and members need to adopt.

Ten Partnering Principles

1. Partnering means learning the needs, wants and desires of others.

2. Partnering builds confidence and trust.

3. Do not take too long to act, as there are others that may beat you to creating valuable partnerships.

4. Partnering strengthens

.

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

your image and defines your culture.

5. You must deposit into the Relationship Bank before you may take a withdrawal.

6. Word-of-mouth is the best advertising available, and you must earn it.

7. People have short positive but long negative memories.

8. Partnering allows for immediate feedback. Ask, "How are we doing?"

9. Partne

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

Companies that provide selfless information through particip

ing creates an environment of possibilities.

10. Partnering is a subtle and successful form of marketing.

To access helpful additional information from Ed Rigsbee at no charge, please visit www.rigsbee.com/downloadaccess.htm. Also, association executives may visit www.rigsbee.com/association.htm for association specific information

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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Diversity is an inside job and leadership must recognize the importance of their decisions on women and people of color. Over the coming decades women and people of color will be operating the businesses as we know them today.

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Digg It - Associations Must Either Partner or Perish

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