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Many software development organizations are reporting great success with agile development techniques. Scrum is an agile,

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

lightweight process that can be used to manage and control software and product development using iterative, incremental

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

Examples of combination products may in

practices. The whole premise is collaborative approach as oppose to serial and sequential as in waterfall method. Most

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 the usability practitioners still feel that there's very little scope of User Centered Design process in Agile Developm

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

ent as it is currently exercised with larger projects and longer development cycles.

My experience with transitioning fr

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

Combination pro

m traditional waterfall method to Agile Scrum has been pretty much enlightening. Earlier, we did have resistance as we ha

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

d very much set processes, deliverables & testing procedures outlined and then changing it entirely to a new Agile proces

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

s which itself was unpredictable did cause inevitable chaos. But, keeping in mind the dynamic changes in business require

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

ents, we did have to cope up on speed and Agility. Chunks of tasks and product milestones were achieved by breaking into

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

manageable sprints and tracking the burn-down chart of product backlogs

We adopted an integrated UCD and SE approach to

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

inimize the risk of overshooting the product release timelines and also not a holistic compromise on Usability. The proce

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

Following aspects would a

ss adopted the following phases:

Requirements and Feasibility

Performed competitive analysis and initial concept

dd to the challenges in developing combination products:

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

models based on contextual enquiries, customer survey & interviews to establish primary user goals and personas. These w

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

re followed by development of user stories and storyboard framework which would be the key artifact throughout the produc

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

t lifecycle

Design and Development

Screen flows with wire frames were developed helped visualization for the dev

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

lopment and Quality assurance teams to build test cases around the user stories. These were backed with contextual scenar

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

Professional from academic institutions, pharmaceutical industries, health care indust

ios and functional descriptions.

Testing and Feedbacks

Intermittent feedbacks were taken more with discount usab

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

ility techniques and fed to design iterations.

The key to the entire integrated design, development and testing effort w

.

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 the user stories that were outlined earlier that formed solid basis to validate business requirements and user needs. T

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

Companies that provide selfless information through particip

he product backlogs were tracked by multiple parallel and the whole agile process was managed by a simple tool ScrumWorks

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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Subjects - Agile Scrum - Incorporating Usability Practices and UCD Processes in Agile Projects

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