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Several years ago now our family life was drastically changed as we were told one of our members had a serious mental illness. First, I thought this can’t be happening. Then, when I got past that, I thought, “Well, if I work hard enough and give enough support, all will be

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

OK. I thought that “being there” for someone meant never looking to my own needs. The result was that I began to suffer from some chronic health issues myself.

But, being a Christian I had always been conscious of how one is to serve others. I was forgetting other passa

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

Examples of combination products may in

es in the Bible which should have reminded me that I was not to do that to my detriment. Matthew 19:19, as well as many other passages, tells us we should love our neighbor as we love ourselves. That last part is often overlooked. How loving of ourselves is it to set no b

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

undaries? How loving is it to not take care of ourselves? If the result of our not taking care of ourselves is that we fall apart, how does that help any situation? Loving our neighbor and ourselves involves not just being nice all the time; it can also mean speaking the

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

ruth with love, and sometimes also putting consequences with that truth.

So, what does self-care look like anyway? We can’t live in this world without being aware of constant messages about exercise and eating properly. And those are important aspects of self-care, but I

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

Combination pro

earned that there is more. I was being pretty careful about my diet, and exercise has always been a part of my life, but still I was developing some health issues. There was more I had to learn.

In my need to have the “perfect” family, I was trying to be all things to all

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

people, and especially to the person I deemed the most needy. The result was I never got enough sleep, I stopped taking time to do any of the things that used to bring me joy, and, worst of all, I kept changing my plans in order to fall in with someone else’s plans. I was

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

totally out of control, all because I wanted to fix the situation. Not only was I not taking care of myself, I was not helping the family situation at all as my ability to function effectively became less.

It has taken time; I did not change overnight. However, gradually I

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

began to become aware of the fact that God still wanted me to have an abundant life. Jesus says in fact that is why He came, so that we could have life and have it abundantly. (John 10:10) He didn’t say we were to have a life with no problems, but He said we were to have

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

n abundant life. For a long time I could not figure out how to do both—have family issues and an abundant life.

Today I still don’t always get it right, but I continue to learn. And what I have learned is to pay attention to my feelings, really pay attention to them, and

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

f I am feeling resentful, then a change of some sort is needed. Sometimes the change is that I have to learn to think differently, but often the change is that I have to set some boundaries to prevent other people taking over my life. I have come to understand that usually

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

Following aspects would a

people are not acting out of malice, but out of their own pain. People in pain cause pain, as I say in my book. But because they are in pain I do not have to allow them to seriously disrupt my life. I can lovingly set limits and stick to them. And in taking care of myse

dd to the challenges in developing combination products:

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

f, I am actually also helping those who right at this time are unable to effectively manage their own lives. I am helping them to learn how to behave, what is appropriate, at a time when they can’t do this for themselves.

There could be many examples in my family of how my

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

learning to set boundaries helped the needy person gain some control over her life, but for this purpose I will use her seeming inability to be on time. The result was the rest of us were left waiting, not getting on with whatever the plan was until she showed up. As you c

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

n imagine, by the time she came we were frustrated and angry, and whatever we were going to be doing was not really enjoyed by anyone. In our not taking care of our own needs, we not only were not helping her, we were blaming her for creating conflict.

Eventually, we learn

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

d to set some limits. There would be a ten minute grace period, and if something came up, we expected to be called. On two occasions when these guidelines were not met, we did not wait and went on with our plans. And those were the last times we ever had to wait, now in o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ver ten years. There have been many other ways we have learned to set limits, and the benefit is two-fold. The person needing the limits now has a structure, help to know what is expected, because people in severe emotional pain are often unable to see what trouble they ar

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

causing others, and what happens then is they get all the blame for causing problems. Now we are able to appreciate the genuine gift this person is in our lives because we have helped her not to be such a disruptive influence. We have come to see all the positives about h

.

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, her strengths, and she has many. In our taking care of ourselves, we changed the whole dynamic of the family for the better.

Yes, we have to pray to learn what boundaries are reasonable, but helping others to grow, rather than keeping them too dependent, is the best serv

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

Companies that provide selfless information through particip

ce we give. When I don’t take care of myself, I am not serving another well either. And, yes, as Christians we are to serve others, but sometimes that service takes the form of saying a loving “No,” for our sakes, but equally, and perhaps even more importantly, for theirs

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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