Why You Shouldn’t Be Developing Medical Devices Without Traceability

Tim Anderson | March 13, 2018

Once your team uses traceability for medical device development, you’ll wonder how you managed any other way.

Building traceability into the process is a critical step to ensure regulatory needs are met, requirements hit and changes managed along the way.

When brought to market, the margin of error for medical devices is near zero. Any defects not discovered and corrected during development can result in patient injury or death, not to mention devastating legal consequences for the company that released the product. With the stakes so high, every step of the development process must be traceable.

Traceability ensures a collaborative and unified timeline from conception to market, meticulously documenting everything in between. It also allows stakeholders to continually monitor timelines, and view how changes affect the team and the necessary response needed.

In essence, traceability lets teams map out interdependencies at each phase of development, ensure all compliance regulations are continually met and changes conform accordingly.

A Unified System of Record for Medical Devices

Heavily regulated products like medical devices require comprehensive audit trails of changes during development.

Traceability enables teams to view and analyze all changes made during development — including who made the change, what it was, when it was made and why it occurred in the first place. Since a traceable development project is kept in a unified system of record, it allows you to revert back to an earlier version of the changes.

Traceability also saves time and effort by communicating requirement modifications directly to the relevant group or individuals responsible in real-time, instead of forcing various team members to pore over the spec to determine if the latest change affects them.

Streamlining Communication for Medical Devices

Collaboration has become a central component of product development teams, and it’s the core of modern traceability.

Bringing all stakeholders together ensures compliance as well as productivity. With everyone on the same page, any potential questions an auditor could raise about process or a development decision can be easily answered. Traceability also makes a product lifecycle and its surrounding processes a living, ongoing entity as opposed to an afterthought. This is vital with the increasing complexity of today’s market.

Bringing Globally Distributed Teams Together

Multidiscipline teams working with different processes and systems must be able to see and understand what their fellow collaborators are doing.

This is especially true in complex spaces like medical device development, and traceability lets remote teams move faster and work together in a more cohesive way. This empowers them to independently make important decisions, based on correct and current data.

Anyone pulled into the conversation during development can be quickly brought up to speed without impeding on the momentum teams have already built.

Adopting Traceability for Medical Devices

Today’s medical devices are so much more than metal and plastic. Software plays a big part in communicating data to patients and doctors. This means the software component must be as traceable as the hardware, since a single instance of incorrect code can become a major liability.

All risk must be considered throughout the product design and implementation. Proper traceability establishes consistent, accurate links between each step of work to ensure the framework protects the user and organization.

Traceability isn’t just about information tracking, it’s about being able to call up that data in the correct format to share with customers and auditors. With Jama, you can track your design and verification within the solution.

Some of our customers complete their risk management analysis around why specific severity was assigned or why a mitigation was applied in a certain way. A single spot for modern traceability around the product you’re developing makes it simple to find the information you need about why decisions were made, as well as understanding their upstream and downstream impacts.

Learn how Jama uses live traceability to let medical device developers locate the source of any decision, manage risk and reference similar past projects in our webinar, “Live Traceability: The Golden Key to Proof of Compliance.”