Encyclopaedia - Writing and Speaking

"You write about so many things," a friend commented. "Where do you get your ideas?" Her question startled me and answering it took weeks. I di

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

scovered that each writing project came from the conscious pursuit of a thought trail. Where do I get my ideas?

REAL LIFE. I wrote two books ab

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

Examples of combination products may in

ut Alzheimer's disease during the nine years I was my mother's caregiver. Right now I am writing about caregiving because I am helping to care fo

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

my elderly father-in-law. I have written about the confusion of dementia, moving a loved one to Assisted Living, buying gifts for someone with

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

emory disease, and more.

MEMBERSHIPS. I am a health and wellness writer and belong to the Association of Health Care Journalists. The AHCJ quar

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

Combination pro

erly, "Healthbeat" and its email network are sources of writing ideas. Because I write about grief I belong to the Association for Death Educatio

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 Counseling and get writing ideas from its newsletter, "The Forum." These memberships also give me speaking ideas.

PERSONAL INTERESTS/NEEDS.

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 an avid cook and love to try new recipes. Early in my career I was a food writer for a city magazine and the experience has served me well.

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

My husband has an artificial descending aorta and I am salt-sensitive and have a food allergy, so we eat healthy. Adapting recipes is part of my

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

daily routine and I have written about healthier oyster stew, fettuccine with tomatoes and artichokes, home made breads, and other foods.

COMMUNI

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

Y NETWORKS. Writing is a solitary experience and I balance it with group experiences like serving on public health committees. The minute a publ

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

Following aspects would a

ic health nurse said teens thought drinking pop before sex prevented pregnancy I had an article idea. This led to a series of "Talk to Your Kids"

dd to the challenges in developing combination products:

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

articles on sex, marijuana, methamphetamine, cigarettes, and risk-taking.

HEALTH ISSUES. Serving on Mayo Clinic's Action on Obesity Task Force h

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

s given me a host of writing ideas. I have written articles about fixing heart-healthy recipes, healthy snacks for families, and making smart foo

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

choices in restaurants, to name a few. More article ideas are rattling around in my mind.

FAMILY. I am blessed to be the grandmother of frater

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

al twins. When my grandson said he only had chips for his school lunch ("The nacho meat tasted funny, the lettuce was brown, the tomatoes were ic

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

Professional from academic institutions, pharmaceutical industries, health care indust

y.") I was appalled. This resulted in three activity books for kids in grades 3-5: "Food Label Detective," "Catching the Exercise Thief," and "Cr

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

cking the Health Words Code." I gave the books to the Minnesota Medical Association Alliance to use with its mission of "building healthy communi

.

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

ies."

Where do you get your writing ideas? You may have more ideas than you think. Carry a small pad with you and jot down every idea as it com

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

Companies that provide selfless information through particip

s to mind. Then, follow each thought trail. Before you know it, you will be swamped with new writing projects.

Copyright 2006 by Harriet Hodgso

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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