Medical Device Development Cannot Be Managed With Documents

Jama Connect for Medical Device Development Briefing Note

By Daniel R. Matlis

The Jama Software executive team recently briefed Axendia on its new Jama Connect for Medical Device Development platform.   The new solution is designed to help engineering teams manage medical device requirements, risk and design control in a single platform. The medical device offering also aims to make regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment while supporting device quality.

“We’re excited to introduce our new solution designed specifically for medical device developers which,  will help ease the development process from the start,” said Josh Turpen, Chief Product Officer at Jama Software.  “Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving engineering teams from the cumbersome and often frustrating process of filing paperwork,” he added.

Medical Device Development Cannot Be Managed With Documents

Medical Devices have become increasingly complex, connected and integrated systems. Yet many engineering teams still rely on documents and spreadsheets to manage development, risk assessments and testing of devices to provide evidence of design control. This approach is no longer viable. Instead, Medical Device Manufacturers must leverage integrated platforms that enable them to focus on the introduction of innovative, high quality products that improve patient outcomes while ensuring compliance to applicable regulatory requirements cost effectively.

Using an integrated development platform supports improvements in product quality and safety through improved visibility and control across the development process and, in turn, reducing risk.  An integrated platform also improves agility and flexibility to mitigate rising product development costs as well as changing regulatory requirements.  In addition, the rise in complexity and connectivity of medical devices requires increased collaboration among software, hardware and support teams to meet project timelines.

 “Device development teams are under pressure to meet quality and compliance standards while staying on pace to hit delivery dates as they develop complex devices,” noted Clay Moore, VP of Customer Success at Jama Software. “Technology, when properly leveraged, can reduce that review cycle by as much as 75%—a vast improvement,” he concluded.

The Jama Connect for Medical Device Development platform supports the following capabilities out of the box:

  • Best practices including procedure and configuration guides to manage design controls, verification and validation, risk management, and adhere to relevant FDA, ISO, IEC and EU regulations
  • Standard frameworks that are aligned to industry regulations and standards including:
    • ISO 13485:2016
    • FDA 21 CFR 820.30
    • ISO 14971:2019
  • Ability to export templates for the design history file (DHF) and risk management file
  • Ease of onboarding to set developers up quickly with training and documentation aligned to industry regulations, while applying a proven systems engineering approach to product development.
Image source: JAMA Software

Customer Testimonials

Grifols, S.A. develops, produces, and markets innovative solutions and services in more than 100 countries. With its team split between Spain and the US, Grifols believed its requirements and risk management processes could be improved.  To provide a consistent development approach and support strong collaboration for its globally dispersed development team, the company implemented Jama Connect.

“With Review Center, we review things more incrementally, and we can catch changes, or things to fix, very early in the process. So, the cost at the end is less,” commented Carmen Pazos, Diagnostic Divisions R&D Instruments Senior Manager, Grifols.

RBC Medical Innovations designs and manufactures a wide range of diagnostic and therapeutic medical devices for industry clients that supply hospitals and healthcare facilities. The company has a semi-manual processes that required significant labor and allowed opportunities for errors.  It also lacked a central development process dashboard to ensure that essential requirements were linked to ensure proper test coverage.

To gain improved visibility into tasks, tests, and costs and to keep team members informed on each aspect of a project, RBC implemented Jama Connect.

“Jama Connect frees us up to focus on the design of the product, not the logistics of the work that needs to be done. We are able to spend our time more effectively — helping our customers,” asserted Scott Britt, Systems Engineering Manager at RBC Medical Innovations

In Brief

As Medical Devices become increasingly complex, connected and integrated systems, engineering teams can no longer rely on documents and spreadsheets to manage development, risk assessments and testing of devices to provide evidence of design control.

Jama Software offers an integrated development platform built to support agility and flexibility to mitigate rising product development costs as well as changing regulatory requirements.  This integrated approach drives improvements in product quality and safety through enhanced visibility and control across the development process.

Complex and connected Medical Device development requires increased collaboration among software, hardware and support teams to meet project timelines.  An integrated solution designed specifically for Medical Device developers can streamline the development process, support regulatory submissions and audit preparations as well as speed time-to-market to support improved patient outcomes.

To learn about the benefits of aligning People, Process and Technology to support Medical Device development register for our webinar on 23-JUN-2020 11:00 AM ET

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