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I found this great article over at A List Apart, Avoid Edge Cases by Designing Up Front by Ben Henick. A list apart is one of the best online journals for finding information and articles about web design and programming written by seasoned professionals. A list

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

apart is pretty strict about who is allowed to author articles, ensuring that each entry is very well written and provides tremendous value.

Henick’s article was no different. In Avoid[ing] Edge Cases by Designing Up Front, Henick outlines, in great detail, a

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

Examples of combination products may in

umber of problems and solutions to planning for success when designing or beginning a large scale web project. What I found most amusing, and of import note was the following:

[I]t has been my experience that too often, a graphic designer will begin

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

a project by building composites or prototypes with the goal of creating an attractive site. While there’s nothing wrong with attractiveness, the look and behavior of a site need to be driven by its objectives.

For “brochure” sites, an emphasis on aesthetic val

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

e is probably acceptable, because many brochure-site sponsors are reluctant to pay for an extensive project-planning phase. Their reluctance isn’t unfair, since most brochure sites have the same business objective: to provide a basic yet attractive web presence

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

Combination pro

or the client, without requiring much in the way of application functionality or other components which require keen attention to the details of the user experience.

However, if the demands of the project go beyond the scope of a brochure, it’s wise to do some

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

ssessment and planning before anyone opens their tools. The six steps outlined above might be adequate for simple sites, but…not every site is simple.

I disagree that, “for ‘brochure’ sites, an emphasis on aesthetic value is probably acceptable.” T

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

o often I have seen brochure site owners, unwilling to spend time or money on research, or development, opting for the quickest, template-like solutions. These same site owners are then the first to complain when results are unsatisfactory. Some type of compromi

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

e needs to be reached. In today’s digital marketing world, even the simplest brochure sites will need to open up (either in front-end user functionality and features, or through different back end avenues and solutions in order to fully exploit the potential of

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

igital, internet marketing).

And the extent to which planning must be done increases exponentially with the size and scope of the overall project.

Larger, non-brochure type sites do require extensive planning and clearly defined goals and guidelines. At the en

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

of the article Henick’s proposes the following as an outlined planning process:

1. Assess objectives and requirements

2. Conduct scenarios

3. Produce wireframes (and establish site architecture)

4. Produce sketches, comps, and (if necessary) prototypes

5.

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

Following aspects would a

Draft the style guide

6. Produce templates and stylesheets

7. Write code

8. Test presentation and behavior

9. Reconcile test results, if possible

10. Publish

With the exception of step 3. or step 5. most of these steps were the same steps my team and I fol

dd to the challenges in developing combination products:

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

owed during the production of one of our largest projects to date, The SERVS management system. Florida Gulf Coast (the University I am currently attending, and where my business partner Harry Casimir is trying to attain his MBA) enlisted our help in creating a

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

ystem to management the connection of Educators (new teachers looking to learn more about their desired profession and grade level) with SERVS Mentors (veteran teachers willing to coach and mentor new teachers).

The site, which took nearly three months to creat

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

required extensive planning, including, most importantly an assessment of objectives and requirements, and conducting scenarios. Of little importance was aesthetic design (or the attractiveness of the system), the role I was assigned to fulfill. First and forem

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

st, the design had to be user-friendly, and secondarily, it had to be extensible. We had to keep in mind that both older, less-computer savvy teachers might be using and registering on the system, and so would more digitally comfortable users. In the end, a desi

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

Professional from academic institutions, pharmaceutical industries, health care indust

n was approved that was attractive (which aided in the overall approval of the full scale project and helped “WOW” FGCU administrators), but primarily it was use able and extensible for the coders.

I would propose an 11th and final step to Henick’s list, a step

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

that many people forget exists. It is often neglected, but it is almost always present, testing & maintenance. Ongoing, post-published, testing and maintenance and constant reviews with the site/system owners will help ensure the project’s continued success. As

.

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

secondary bonus, this constant testing & maintenance can be a continued source of revenue for a site designer as well as a consistent resource for project planning & client management. Review your mistakes, don’t make them on your next project, implement plans

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

Companies that provide selfless information through particip

hat streamline some of the hurdles you had to get over during your first attempt.

Stay Tuned for Part 2 of this article where I will discuss in more depth, Web Site Project Planning, Specifically the final step, how to plan and accommodate post-launch processes

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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A series of articles exploring the seven critical areas that can indicate a partnership is in trouble. Conflict Becoming the Norm – Part 2 In a previous article, I wrote about how unresolved conflict...

In PART I of this article, I began by emphasizing on how big the internet has grown over the years. Now I'll begin by telling you how small the internet really was when it first started. You'll be surprised to know that this web of interconnected machines, which now makes our lives so much more convenient, was nothing more than just four computers using 50 Kbps lines to transfer small packets of information across three states. There were no more than a handful of people who had access or even knew about the project.

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