Advice Pool - Relationships

Relationships permeate every facet of life. The quality of your relationships in various arenas (career, family, 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

ntimate relationships, friendships, relationship to self) dictate the quality of your life experience. The focus o

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

Examples of combination products may in

this month's newsletter is on understanding and harnessing the power of Relationship Reflections or RR's.

What is

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

a Relationship Reflection?

Each relationship you have acts as a mirror reflecting back to you exactly what you ne

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

d to pay attention to and work on. The messages our relationships give us constitute the RR. The RR can be positi

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

Combination pro

e or negative. Usually, what is reflected is your unconscious/unspoken hopes, feelings, expectations, judgements,

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

and values. When you pay attention to what RR's are saying, you are able to tap into the areas that need the most

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

mprovement.

Recently, I worked with a client who felt frustrated with one of her relationships. K was an acquaint

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

ance that seemed to bring out the worst in my client. After each interaction with K, my client would become snappy

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

and short-tempered. Through examination and self assessment, my client was able to describe what her relationship

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

ith K was reflecting back to her. Because K shamelessly advertised her personal, career, and financial accomplishm

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

Following aspects would a

ents, my client concluded that K's behavior was not only inappropriate but also unacceptable. When she looked a li

dd to the challenges in developing combination products:

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

tle deeper into her feelings, my client realized that interacting with K stirred up her own feelings of disappointm

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

ent, insecurity, and jealousy. By understanding what her RR was telling her, my client was able to address her own

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

needs and work through her unattended-to feelings. As a result, my client was able to fortify her boundaries, reli

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

quish her expectations, and come to terms with her relationship.

You will notice that certain themes run through n

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot just one but several relationships. Such themes can include: compassion, support, collaboration, insecurity, j

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

alousy, personal expectations or disappointment. By paying attention and working through your RR's, you can learn

.

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

to respond rather than react, communicate your needs authentically, eliminate the should's and could's, and fully e

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

Companies that provide selfless information through particip

press yourself without fear. Relationship Reflections serve as your personal navigation system leading you to MORE

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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Advice Pool - Understanding and Using RR's; Relationship and Reflections

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