Tag Archive for: Risk Management Plan

Companies are facing intense pressures to bring complex products to market faster than ever. In addition, those delivering products in safety-critical markets must also create and execute against a risk management plan for expanding standards and regulatory oversight.

In these cases, inefficiencies and blind spots in the development process can lead to risk management errors which not only throw releases off schedule but can put lives in jeopardy.

To help raise awareness around these issues, prominent research and consulting firm Frost & Sullivan recently observed the product development landscape and its relationship to risk. The output is a recently-released brief, “Safeguarding Regulated Products Amidst Growing Complexity,” that spotlights Jama Connect™ as a remedy for ineffective risk analysis in product development.

Symptoms of Ineffective Risk Management

The Frost & Sullivan brief outlines the current competitive environment facing organizations producing products in regulated industries and makes the case that relying on outdated processes impedes success.

“Many businesses in these spaces have invested heavily over the years in their document-based systems to manage their product development process and are hesitant to upgrade to unknown technologies or solutions,” writes Frost & Sullivan. “These antiquated systems are often static and spreadsheet- or even paper-based. And while they may offer a (possibly false) sense of reassurance against the costs and risks associated with a live digital system, they end up creating more costs and causing more harm.”

As we’ve heard from many companies, performing requirements management and risk analysis through versioned spreadsheets and extensive meetings not only drains resources, slows development, and creates errors, but it’s just no longer an effective strategy when you need to build safe products quickly.

Gain a stronger handle on ISO 14971 — the FDA’s mandatory standard for risk assessment in medical devices — by grabbing our whitepaper.

Strengthening Collaboration During Development

One other notion dispelled by Frost & Sullivan is the idea that remote development teams can operate at maximum efficiency without a powerful, shared solution for centralized enablement.

For instance, with regulated companies, there’s too much at stake to leave issues around requirements, risk mitigation, and compliance up to emailed documents.

“A strong, platform-based solution can provide a virtual space in which different but interdependent teams can collaborate, key stakeholders can review and weigh in on decisions, and regulators can trace end-to-end compliance,” writes Frost & Sullivan. “It can also enable risk mitigation as an ongoing, semi-automated process that catches and integrates changing conditions. Such a solution can help ensure compliance across processes, functions and locations, as well as with product definitions and design, processes and test cases.”

Learn how how a Fortune 100 semiconductor company is meeting the challenges of developing automotive-related technology by downloading our case study.

A Better Risk Management Solution

For businesses still hesitant to invest in improvements to their risk management process, it’s not always strictly a question of budget. The move involves a change in mindset and executable process, according to Frost & Sullivan. For instance, tracking and managing risk needs to be an intrinsic, collaborative, ongoing part of the development process, and not something performed by a specialized team in a silo.

Some organizations, especially newcomers to regulated industries, may not even be sure where to start with complex standards like ISO 14971, let alone assembling a risk management plan. It’s in these cases you’re more likely to see a development team dig into a risk management framework in the later stages of development, potentially adding rework and cost when schedules and budgets may not allow for either.

Frost & Sullivan contends Jama Connect is worth a look for all organizations interested in mitigating product risk, as it can “provide risk management, collaboration, efficiency and regulatory compliance as aspects that strengthen, rather than complicate, each other.”

Whichever path a company chooses, what Frost & Sullivan make clear is that staying the course with an ineffective risk management process isn’t really an option at all.

“Teams will otherwise struggle to get their people up to speed, across the globe and across groups,” writes Frost & Sullivan. “A team-based approach… is the ideal solution in heavily regulated industries.”

Access the full Frost & Sullivan brief, “Safeguarding Regulated Products Amidst Growing Complexity” by downloading it now.