Summary - Relationships

Anyone who has been in a relationship with another person knows that they grow complex very quickly. Relationships in this area of our lives are not mechanical. Since they are not mechanical, simplistic explanations do not fully ex

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

press or explain what occurs. When things are going well in that relationship, few people consider trying to understand or improve what they are doing. When things go bad, people began looking for answers. Since they are hurting, t

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

Examples of combination products may in

ey often want simple answers. Operating a garage door opener requires the operator mash the button. Once the button is mashed, the electronic device opens the door. Such an interaction is purely mechanical, and can be explained in

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

ike manner.

Relationships between people involve reciprocal interactions. When reciprocity is brought into relationships, mechanical explanations do not convey the interactions that take place. Although there may be some interacti

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

ns that seem to occur in a mechanical manner, there are variations added that make the interaction increasingly complex. Let us return to the garage door opener to illustrate. When the button on the opener is mashed, the door open

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

Combination pro

. Only this time, the opener decides it did not like the amount of force used in mashing the button, so it changes the sensitivity level of the button. The next time the operator mashes the button, they may have to push with just t

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

he right amount of pressure to make it open. The door opens, as it has before, but the reciprocity involved in the first interaction has altered the relationship between the two of them. On the surface, the door still opens in a me

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

hanical manner, but the way to open the door has changed.

Relationships between two individuals begin with two people meeting. On meeting, there is often an acknowledgement of the other person’s presence. The acknowledgement is f

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

llowed by an exchange of greetings and often some type of small talk. The small talk consists of addressing a neutral topic. This is often sports, the weather, current events or their immediate surroundings. Besides verbal communic

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

tion, there are also non-verbal messages also occurring in the interaction. Many of the skills required in starting relationships are learned in childhood to early adolescence. Although many people learned the basic skills of how t

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

meet people and start conversations. Issues such as experience, confidence and self-image interfere with exercising those skills by either adding to or distracting from the basic skills.

Some people learn how to initiate relation

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

Following aspects would a

ships, but have not learned or mastered the skills necessary to engage the other person or take the relationship beyond the introductory or acquaintance level. Specific skills are needed at the various levels of relationships. Each

dd to the challenges in developing combination products:

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

level of relationship requires specific skills associated with it. The question arises as to “What are the required skills of relationships?”. The psychoanalyst Erich Fromm understood this dilemma. He identified some of the qualit

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

es necessary for the relationship to develop. “There are no easy instructions on relationships. To engage in relationship requires humility, courage, faith and discipline”. It is often easy to meet people. Work is required in impro

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

ing the quality of the relationship beyond the acquaintance level. Although movies make it look as though relationships magically go from acquaintances to a healthy relationship with time and a little effort. The truth is that rela

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

ionships require time and effort on the part of both persons. The best illustration of how relationships work is dancing. In dancing, the two partners work as a team. As part of that teamwork, there are many interactions going back

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

Professional from academic institutions, pharmaceutical industries, health care indust

and forth between them involving directions, attitude, preferences, style of dance, etc. The rookie dancer believes all they need to know is the correct dance steps and they can master any dance. When the inexperienced dancer mess

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

s up they look for simple answers like what step they missed. In some cases, it may be a missed step. In many cases, it is more complicated than a missed step, or what led to the missed step. The inexperienced dancer is not ready f

.

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

r other explanations, nor do they have the vocabulary to grasp the explanation. At that point all they understand is the missed step. As a dancer gains experience and skill in dancing, they can more readily understand the subtletie

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

Companies that provide selfless information through particip

and interactions behind mess ups and what it takes to make a great dance. When your relationship needs improving, recognize it requires work, and seek help from those who have experience in the interactions and subtleties involved

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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Summary - Looking for Simple Answers to Relationship Problems?

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