FDA Turns To Appian BPM To Improve Efficiencies

The U.S. Food and Drug Administration (FDA) will employ BPM from Appian and  immixGroup to streamline and manage key business and governance processes. One goal of the five-year contract aims to speed approval and certification of medical devices.   

Tags: business process management, BPM, Appian, business rules, enterprise architecture, cloud, dashboard, metrics, process, KPI, FDA,

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The U.S. Food and Drug Administration (FDA) will employ BPM from Appian and  immixGroup to streamline and manage key business and governance processes. One goal of the five-year contract aims to speed approval and certification of medical devices.   

The FDA’s five-year Blanket Purchase Agreement with Appian and immixGroup is valued at approximately $12 million, company officials said. The FDA is expected to use the BPM platform across all its centers to better align processes between groups and departments, and improve management of several core business processes, according to Appian officials.

FDA’s larger commitment to BPM comes after success with a targeted pilot project, Samir Gulati, Appian’s vice president of marketing told IDN. 

In 2008, the FDA did a BPM pilot rollout for an application called iReview, which automates the pre-market certification of medical devices.  The pilot was designed to test whether BPM might improve compliance and regulatory tasks, Gulati said. “It was the success of this pilot project that has now led to this larger, multi-year BPM contract with FDA,” he added.

How FDA Saw the Light with Big Benefits from BPM
So, what happened in the first pilot project to make the FDA a believer in BPM?

“The light bulb went on about benefits from BPM, when [the FDA] started to see impressive stats on time to market and time to value,” Gulati told IDN.

Specifically, FDA realized benefits in weeks across wide areas of the iReview process, Gulati said.  “FDA found BPM helped them with better compliance, risk management, visibility and more timely audit trails,” Gulati said. “We also helped them ensure all steps in those processes were documented and that everyone in reviews and approval cycles were informed.”

samir_headshot_smallAnother key benefit was ensuring that processes were applied consistently to all devices.  “Because processes and approvals were now able to be more built into how FDA does work in this area, no steps get missed or done in the wrong order -- and nothing gets sent out prematurely,” Gulati said. Because procedures were always followed, process efficiencies and quality of approvals were improved.

Gulati told IDN the key takeaway was that when it came to return on investment, which can typically take six to nine months or more, the Appian BPM Suite approach could accrue these benefits to FDA much more quickly.

A key to the quick ROI, Gulati explained, comes from its BPM Suite approach, which unifies many needed aspects of BPM in a robust but flexible architecture layer that can be deployed on premise or as a cloud-based SaaS (software as a service) model. 

This approach meant that Appian BPM could drastically reduce installation and training times for FDA, and virtually eliminate IT maintenance. On the end-user side, Appian BPM comes with a customizable user interface, which allows dashboards and screens to be designed for each user, helping to reduce user training time. 

But there was one more “ah ha” moment for FDA reviewers, Gulati said.

As the pilot project was wrapping up, the FDA realized even though it only applied BPM to one process, the technologies could be easily extensible to support more complicated tasks that included many inter-related and dependant processes.

“That ease of extensibility, we believe, was key to the FDA’s further adoption,” Gulati said. “FDA, and many other areas of government, now realize that BPM can take on projects that require management of multiple processes.”   

Architecturally speaking, the components of Appian BPM Suite and Architecture support: 

Business Process
Simple web-based modeling using BPMN and SOA methodologies for rapid development and automation of business processes.

Business Rules
Automate, enforce and audit policies and practices with agile, centrally-managed business rules.

“The light bulb went on about benefits from BPM, when [the FDA] started to see impressive stats on time to market and time to value.”

Samir Gulati
Vice President
Appian


Portal and Forms
Rich portal, dashboard, and forms creation tools enable users to quickly build simple interfaces that deliver personalized content to complete work faster.

Content Management
Integrated document and content management platform provides robust functionality to store, secure, version, search, and manage enterprise content.

BAM Reporting & Dashboards
Ability to track real-time process performance and create rich reporting dashboards. This tie between UI and backend progress and metrics allows users to  identify process bottlenecks, and optimize process efficiency flow.

Identity Management
Integrate into the corporate directory to intelligently route tasks and content using skills, roles, or dynamic group structures.

Data and Integration
Connect data sources and integrate quickly using standard SOA development to build a repository of re-usable services that accelerate BPM deployment.

Collaboration
Encourage collaboration with threaded discussion boards, targeted content, and fast content sharing across all users. The result is smarter business decisions

Appian Says Ensuring BPM Success
Needs More Than Architecture

But for all the work Appian has done with its architecture, Gulati added a successful BPM project often requires more than technology.  It requires working with the client to understand his process, ensure it is efficient and then set in place ways to measure that KPIs (key performance indicators) are met. This means “process discovery” is also another area where Appian works with clients, such as FDA, Gulati said.

“Once we start a BPM project, we sit down with knowledge workers and process managers and try to derive the business processes involved in getting their outcomes or their KPIs, as well as each step and what needs to happen there and by who,” Gulati said. 

To achieve this, Appian has developed a wizard that can build a basic process map based on key information it gathers, such as steps in a process, who is responsible, who needs to review and approve, etc.

“This is really classic case management,” Gulati said.  “And when you have a process entirely understood and handled by a [BPM] system that means the worker can better execute that process, where human intervention is required, and also more quickly be notified if some item is out of process, and even check the analytics and metrics on a case  and see where it is in the process and how long it might take to get through the process.”

Under the five-year contract extension, Gulati expects the Appian/immixGroup BPM solution to be used by all FDA Centers to execute on many of the agency’s process improvement goals.

 




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