Improving the assessment of medical devices

Medical Devices Director, Catherine Epps, says Pharmac and Health NZ are working together on a coordinated national approach to medical device assessment, with a strong focus on improving transparency and collaboration.

“Our goal is to make assessment processes clearer, engage meaningfully with suppliers and clinical communities in the design of these processes, and ensure we are focused on those areas which add the most value to the sector.”

A key part of this work is the joint Health NZ and Pharmac development of a national entry point for medical device assessments. This is intended to provide a more consistent pathway for assessing new technologies.

In the coming months, we will also trial a new application process designed to ensure suppliers aren’t putting unnecessary effort into applications unlikely to be progressed, and that Pharmac and Health NZ are getting the information needed from these applications to undertake a fit-for-purpose assessment. This process will be tested with a small number of submissions and refined using feedback from the Medical Devices Supplier Reference Group and other stakeholders.

“The Supplier Reference Group members are a cross‑section of suppliers and manufacturers. It has been established to help us understand what’s working well, what isn’t, and what needs to change; based on their experience in the sector,” says Epps. 

“These are some of the people who will be using any new processes and forms we design. It’s vital that we make it as easy as possible for them to interact with us. They also play an important role in helping bring innovative technologies to New Zealand, so it's important that we work closely with them to get these processes right.”

Alongside this, Pharmac is continuing to strengthen the specialist advice that supports medical device category management and decision-making. This includes:

• Establishing an Endomechanical and Electrosurgical Advisory Group (EEAG).
• Re-establishing the Wound Care Advisory Group. 
• Establishing a Cardiac Electrophysiology Advisory Group. 

“When we're assessing these technologies, it's essential that we seek clinical advice from the people who use them every day. They understand the practical realities of delivering care in New Zealand and the factors that need to be considered before decisions are made.” 

Epps says clinical expertise is critical to understanding how medical devices will work in practice and inform decision making.

This work will continue to evolve over the coming months, and we'll be working closely with suppliers and clinical communities along the way. If you're a supplier, you can expect to hear from us regularly as we test new approaches and refine processes to make them easier to navigate and more effective for everyone involved. 

More information 

Meeting summaries and information about the Supplier Reference Group