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People sign up for my grant writing workshops to learn to write grant proposals. I often find they have great ideas, big hearts, 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

nd lots of activities that they believe will make a difference. What I tell them all—even those who want to hire me as a grant wri

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

Examples of combination products may in

er—is they need a sound plan before they start writing. There are an infinite number of activities that one can engage in on behal

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

f of hunger, literacy, homelessness, pollution, etc. If these activities aren’t linked to objectives plotted to reach a goal, you

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

ill be exhausted with no measurable differences occurring over time. If you’re attempting to address the root causes of issues, pl

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

Combination pro

an first, and focus your energies in ways that are more apt to move your organization toward your realization of long-term goals.

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

How is planning different from answering the questions posed in a grant application?

Strategic planning is a process of thinking

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

through a project in light of every imaginable detail. A great plan is based on reality. It factors in:

* what you intend to acco

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

plish;
* the resources that you have as an organization;
* any partners or stakeholders who care about and support your

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

vision; and
* your strengths and weaknesses.

After you’ve identified this information, you can begin to plot the kinds of ac

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

ivities you might deliver. There are so many ways to tackle a problem or issue. Your approach must be based on the above informati

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

Following aspects would a

n, as well as the specific needs of the clients, environment, or issues addressed. This requires hours and hours of research. Cons

dd to the challenges in developing combination products:

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

ider how many agencies and organizations receive grants and run full time, and yet there are negligible changes after years or dec

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

des of project implementation.

Which brings us to research-based approaches.

Many funders now want to know whether there is rese

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

arch that supports your proposed methods for grant implementation. We can all brainstorm and come up with lovely ideas, but succes

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

es are based on more than fantasies. Just think of how many concerns there are about the education system. In spite of billions of

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

Professional from academic institutions, pharmaceutical industries, health care indust

dollars invested, significant numbers of children still can’t read. Now, however, there is a growing body of research that suppor

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

s using particular strategies to ameliorate specific conditions and challenges. Such research reinforces the wisdom of your choice

.

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

s for intervention or prevention programs.

Strategic planning can be a time-consuming endeavor, and it delays our desire to get t

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

Companies that provide selfless information through particip

e money yesterday; however, writing a winning grant proposal that will make a difference is hinged on in-depth thinking beforehand

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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Latinos have a special affinity for business because of our cultural heritage. Elements of our heritage, however, provide both challenges and opportunities -- elements like family focus, faith and concepts of fate. We can make the most of our cultural opportunities through education, expanding our mindset and getting out of our own way.

Do you ask prospective clients to go too far? Must your new clients take a “leap of faith” when they engage you? Or do you gradually draw them closer using a series of pre-planned contacts designed to address their concerns and build their trust in you.

Seize control of your software development with the right amount of requirements documentation. Create an MRD or PRD and use it as a roadmap for your software outsourcing.

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