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Where is our success? Although there have been improvements, over 60% of projects/programs failed and many were canceled in 200

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

3 (ref:The Standish Report CHAOS)! Our goal for 2004 and beyond is to contribute to a 60% and better, project/program success r

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

Examples of combination products may in

te! STOP THE MADNESS-MANAGE AND CONTROL PROJECTS

WITH THE FOLLOWING:

Best Practice Processes for Project/Program Success(Outli

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

ne):

Program/Project Management (and Business Management) (Integration)
- Use of Experience and Knowledge (I

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

tegration)

Planning and Scheduling/WBS (Scope/Time/Cost)

Communication Planning (Communication)

Status & Earned V

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

Combination pro

alue Reporting (Communication)

Performance (metrics) Reporting (Communication)

Risks Identification and Management (Ri

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

ks)

Project Repository/DB (Communication/Lessons Learned/Knowledge Transfer)

Change Management (Integration)

Subc

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

ontractor/Vendor Control (Procurement)

Team Building (Human Resource)

Development Process (Integration/Solution

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

Scope)

Selection of the appropriate model/technique (e.g., Interactive, Waterfall, Spiral, Evolutionary Object Orient

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

ed, Structured)

Selection of the appropriate implementation methodology (e.g., MSF, RUP, GXP, DOD- STD 2167 and other stand

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

rds)

Selection, if required, to use Rapid Development

Rapid Application Development/Joint Application Development (RAD

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

Following aspects would a

JAD)

Prototypes and Mockups

Interviews and Facilitated Sessions

Collaboration

Selection of technical and pro

dd to the challenges in developing combination products:

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

ject reviews

Selection of development and support tools and applications

Configuration Management (Integration/

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

cope/Control) (described in the book "Software and Firmware Configuration Management", subtitled "Management Control and Quality

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

".)

Configuration Identification
Configuration Control - Software/Application, Firmware (Embedded Software, and

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

ystems)

Configuration Status Accounting

Configuration Audits

Quality Assurance (Integration/Quality/Contro

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

Professional from academic institutions, pharmaceutical industries, health care indust

Verification
Validation
Testing

Some of the organizations that support these practices an

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

certifications for their professional knowledge recognized in many industries are: Project Management Institute (PMI) , America

.

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

n Management Association (AMA), Software Engineering Institute (SEI), Electronic Industries Association (EIA), Institute of Elec

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

Companies that provide selfless information through particip

rical and Electronic Engineers (IEEE), International Organization for Standardization (ISO), and the Department of Defense (DOD)

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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