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"The cruelest lies are often told in silence." — Robert Lewis Stevenson, 19th century Scottish poet, novelist, and essayist

We can't build a team or organization that's different

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

from us. We can't make them into something we're not. Failing to follow this principle is the single biggest reason that so many team and organization change and improvement effort

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

Examples of combination products may in

flounder or fail. The changes and improvements we try to make to others must ring true to the changes and improvements we're also trying to make to ourselves. The following is a c

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

ecklist:

Are You Trying to Make Your Organization or Team Into Something You're Not?

To What Extent am I:

Attempting to change my organization or team without changing myself?

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

_ Prodding my organization to be more people (customer/partner) focused when I am a Technomanager (driven by management systems and technology)?

__ Driving for industry or market

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

Combination pro

eadership when I am afflicted with the Pessimism Plague and/or Victimitis Virus?

__ Striving to stimulate and energize others when I am not passionate about my own role and life'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

work?

__ Promoting organization or team vision, values, and mission when my own picture of my preferred future, principles, and purpose aren't clear and/or well aligned with where

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

I am trying to lead others.

__ Pushing for a customer-driven organization while controlling and dominating, rather than serving (servant-leadership)?

__ Aspiring to develop new m

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

rkets and fill unmet needs while spending limited time with customers, partners, or those serving them?

__ Trying to build a learning organization when my own rate of personal gro

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

th and development is low?

__ Declaring the urgency of higher levels of innovation while I stick to familiar personal methods and traditional command and control management approa

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

hes?

__ Aiming for disciplined organization or team goal and priority setting when I am not well organized, a poor personal time manager, and fuzzy about my own goals and prioriti

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

Following aspects would a

es?

__ Setting organization improvement plans without an improvement process of my own?

__ Promoting teamwork and a team-based organization without providing a personal model of

dd to the challenges in developing combination products:

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

eam leadership and team effectiveness in action?

__ Supporting high levels of skill development — for everyone else?

__ Forcing accountability, performance appraisal, and measure

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

ent on others while I defend, avoid, or half-heartedly gather personal feedback?

__ Proclaiming empowerment and involvement while controlling and limiting people with a centralize

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

structure and systems that constrain rather than support?

__ Talking about the need for better communications without becoming a strong and compelling communicator?

__ Establish

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

ng formal reward and recognition programs when my personal habits of giving sincere recognition and showing genuine appreciation are weak?

__ Espousing support for change champion

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

Professional from academic institutions, pharmaceutical industries, health care indust

while suppressing "off the wall" behavior and pushing people to follow my plans and stay within in my established system?

__ Advocating reviews and assessments while doing little

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

personal reflection and contemplation?

What do my answers tell me about my leadership? Does this exercise help explain the positive, negative, or so-so results of the team and org

.

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

nization improvement efforts I lead? My reflections are important, but an even better source of feedback are the people on my team or those in my organization who know my leadershi

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

Companies that provide selfless information through particip

behavior well enough to give me some feedback. Ironically (and tragically), managers who need it most — the weakest leaders — are the least likely to ask for this kind of feedback

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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As a non-profit organization, your number one goal is fundraising and marketing your organization. The trick to successful fundraising, however, is finding ways to market the event without spending a fortune.

Raising funds can be really hard especially if your organization is not known or when it is just starting its operations. Face it, with today's rising commodities, people do not part with their money that easily. They need a very good reason to do this.

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