Summary - Relationships

Setting personal boundaries are like identifying the gates in our invisible fence lines which protects the precious heart and soul inside our bodies. Many people look a

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

t boundaries as walls, but rather when we establish healthy boundaries it provides a way to distinguish what we choose to let in and let out. They form flexible gates,

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

Examples of combination products may in

not stationary walls It is important to learn about setting healthy boundaries so we can make decisions about what is and what isn’t permissible in all relationships.

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

b>Boundaries are valuable

All relationships work more harmoniously when the participants know what to expect and what is expected of them. Being kind, but firm whe

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

n stating what you need from a relationship allows the other person to reciprocate. How other people act and think often has nothing to do with you, but rather with th

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

Combination pro

eir own perceptions. You can only take care of yourself.

It doesn’t matter how elaborate the fencing and eloquent our statements are, if we don’t honor ourselves enoug

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

h to draw the line and stick to it consistently. It is just as valuable to the other person that they learn how to be with you and what the guidelines are for the relat

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

ionship.

Body Language and tone of voice

Verbal communication is the language of information and only 20 % is absorbed. Body language and tone of voice is the

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

language of relationships and 80% is remembered. Make sure you appear confident and you speak with a neutral, calm and non-accusing tone when establishing your boundarie

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

s. Use “I” statements which reflect on how things affect you, rather than “you” statements which put people on the defensive.

4 Step model for setting boundaries

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

1. Calmly inform the other person by stating, “I feel uncomfortable and want to shut down when you yell at me.”

2. Request that they honor your boundary. “I as

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

Following aspects would a

k that you talk to me without yelling.” Or ..For me to listen and hear what you are saying to me, I need to you speak to me in a calm voice without yelling.

3. Insis

dd to the challenges in developing combination products:

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

t that they honor your boundary, again with a firm but kind voice, “I insist that when we are talking we talk in calm voices.”

4. Leave the situation. Now is not

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

the time or place to continue communicating with someone who refuses to respect your boundaries. Leave the door open to talk later in a more respectful manner. Continu

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

e to maintain a calm but firm voice and say, “I will not continue this conversation in this way. I welcome an opportunity to talk with you without yelling or screaming

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

at another time. Let me know if you decide to visit without raised voices.”

Don’t take it personally

You can not assume responsibility for other people’s feeli

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

Professional from academic institutions, pharmaceutical industries, health care indust

ngs, agendas or methods of communication. You can only state how you desire to be treated in life. If there are old patterns, it may take some time to convince others

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

that you are serious about sticking to your boundaries. Everyone has the right to be treated with respect and courtesy.

People you know may be surprised at first when y

.

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

ou tell them they have crossed the line, but will respect you more in the end. Hopefully, they will model this communication style and it will make for more honest and

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

Companies that provide selfless information through particip

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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