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Ineffective functional specification for Web projects such as Web sites, Intranets or Portals contribute largely to delays, higher costs or in applications that do not match the expectations. Independent if the Web site, Intranet or Portal is custom developed or built on packaged software such as Web-, enterprise content management or portal so

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

ftware, the functional specification sets the foundation for project delays and higher costs. To limit delays and unexpected investments during the development process, the following pitfalls should be avoided:

Too vague or incomplete functional specification: This is the most common mistake that companies do. Everything that is ambiguo

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

Examples of combination products may in

usly or not specified at all, developers do not implement or implement in a different way of what site owners want. This relates primarily to Web features that are considered as common user expectations. For example, HTML title tags, which are used to bookmark Web pages. The Web steering committee may specify that each page contains a page titl

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

e, but does not specify that HTML Title tags needs to be implemented as well. Web developers therefore may do not implement HTML Title tags or implement them in a way, which differs from site owners' visions. There are other examples such as error handling on online forms or the definition of ALT texts for images to comply with the disability a

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

ct section 508. These examples look like details but in practice, if developers need to modify hundreds or even thousands of pages, it amounts to several man-days or even man-weeks. Especially, the corrections for images as business owners need first to define the image names prior that Web developers can implement the ATL texts. Ambiguous func

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

Combination pro

tional specification can result due to the lack of internal or external missing usability skills. In this case, a one-day usability best practice workshop transfers the necessary or at least basic usability skills to the Web team. It is recommended, even for companies that have usability skills or rely on the subcontractor's skill set, that an

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

external and neutral consultant reviews the functional specification. Especially, as such reviews relate to marginal spending as compared to the total Web investments (e.g. about $10 K - $15 K dollars for a review).

Future site enhancement not identified or not communicated: It is crucial that the Web committee identifies at least the m

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

jor future site enhancements and communicates them to the development team. In the best case, the development team knows the roadmap for the coming three years. Such an approach allows the development team to anticipate implementation choices to host future site enhancements. It is more cost effective on mid- or long-term to invest more in the

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

beginning and to build a flexible solution. If Web teams do not know or even ignore future enhancements, the risk for higher investment increases (e.g. adding new functionality in the future results in partially or at worst in totally rebuilding existing functionality). Looking at the financial delta for a flexible solution versus a solution ju

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

st satisfying the current requirements, the flexible solution has proven to be more cost-effective in practice from a mid- and long-term perspective.

Planned functionality not aligned with internal resources: Many companies look at site functionality only from a site visitor perspective (e.g. facilitation of searching information or per

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

forming transaction) and corporate benefits (e.g. financial benefits of self-service features). However, there is a third dimension the impact of site functionality on internal resources. Site functionality that can heavily impact internal resources are for example:

- Web sites: providing news, online recruitment, online support, etc.

- Intr

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

Following aspects would a

anets / portals: providing content maintenance functionality for business managers.

It is crucial for the success of site functionality that the Web committee analyzes the impact and takes actions to ensure operations of the planned functionality. For example, providing the content maintenance functionality to business owners and product mang

dd to the challenges in developing combination products:

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

ers with an associated workflow. This functionality is effective and can generate business benefits such as reduced time to market. However, in practice, business owners and product managers will need to write, validate, review, approve and retire content. This results in additional workload. If the Web committee has not defined in the Web gove

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

rnance (processes, policies, ownership and potentially enforcement), it may happen that this functionality is not used and hence becomes useless.

Wish lists versus actual needs and business requirements: The functional specification is not aligned with user's needs or business requirements. This is more common for internal applications

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

uch as Intranets or portals. In many cases, the project committee neglects to perform a sound internal survey and defines functionality by generalizing individual employees' wishes without any sound proves. Capturing the feedback of internal users across the organization allows determining the critical functionality. To effectively perform a su

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

rvey a representative set of employees need to be questioned. Further these employees need to be categorized into profiles. The profiles need to be characterized by for example, frequency of usage of the Intranet, estimated duration by visit, usage of the Intranet to facilitate their daily tasks, contribution to the business, etc. Based on this

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

Professional from academic institutions, pharmaceutical industries, health care indust

information the Web team can then prioritize the functionality and choose the most effective and relevant functionality for the next release. Less critical or less important functionality may be part of future releases (roadmap) or dropped. If such a sound decision process is not performed, it may happen that functionality is developed but onl

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

y used by few users and the return of investment is not achieved.

Not enough visual supports or purely text based: Textual description of Web applications can be interpreted subjectively and hence leading to wrong expectations. To avoid setting wrong expectations, which may are only discovered during development or at worst at launch ti

.

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

me, functional specification need to be complemented by visual supports (e.g. screenshots or at best HTML prototypes for home pages or any major navigation pages like sub-home pages for the major sections of the site such as for human resources, business units, finance, etc.). This allows reducing subjective interpretation and taking into accou

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

Companies that provide selfless information through particip

nt the users' feedback prior development. Such an approach helps setting the right expectations and to avoid any disappointments at the end once the new application is online.

We have observed these common mistakes, independently if companies have developed their Web applications internally or subcontracted them to an external service provider

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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