We believe that manufacturing is as crucial to the success of a MedTech venture as the product itself.

At IDE, we set up manufacturing for medical devices, manage production, and ensure supply to customers.

Our Approach

  • We apply best practices to design optimal manufacturing processes, challenging preconceptions to meet the commercial requirements of the business.
  • Our process is agnostic, utilising our supply chain or developing processes for our clients or third parties.
  • Our services include supplier management, tooling, production process development, quality controls, process validation, and automation.

  • Our manufacturing resources are part of the core cross-functional team from a project’s inception.
  • New Product Introduction (NPI) activities are managed within an agile project management framework and scaled according to project constraints and priorities.
  • Our NPI activities include manufacturing strategies and plans, design for manufacture & assembly, cost of goods analysis, prototyping, device master record & quality assurance, design transfer and pilot production.

  • IDE’s manufacturing capabilities and supply chain can quickly set up and produce new products, providing low to high volume production.
  • We are certified to ISO 13485 for the contract manufacturing and assembly of medical devices and in vitro diagnostic devices.

  • Producing saleable product for the first time can uncover unforeseen issues, and IDE is uniquely positioned to address these quickly.
  • Having product development and commercialisation resources adjacent to manufacturing ensures security of uninterrupted product supply.

  • IDE can act as the legal manufacturer for products, providing all necessary services including product registration, regulatory approvals, production, distribution, marketing & sales, and post-market surveillance.

  • IDE provides post-market surveillance, production monitoring, and lifecycle management activities, including product improvements, issue management, process improvements, and end-of-life management.

  • IDE helps clients scale up production to meet growth, whether it’s increasing capacity, lowering costs, or improving logistics.
  • We apply our capabilities, resources, and processes to execute a successful scale-up, ensuring maximum commercial return.

Whether scaling up production at IDE, transitioning it in-house, or outsourcing it to a third party, IDE can leverage its capabilities, resources, and processes to ensure a successful scale-up and maximise commercial returns for our clients and partners.

Our business strategy and development services are geared towards achieving the optimal end product for all stakeholders involved, grounded in practical experience and a commitment to tangible results.

– Richard Sokolov
Executive Director and Co-Founder IDE Group

Our Global Manufacturing Presence

IDE Group placed high importance on relationship building. This enabled efficient communication with project stakeholders to keep the project moving smoothly.

– Lee Veliss
Section Leader Patient Interface, ResMed

Our Projects

Clinician communicates to woman as she prepares her for CT scan, Medran centargo to the right

Bayer

MEDRAD® Centargo CT Injector

Together with Bayer, we not only successfully invented a novel product but changed the face of injectors to come.

Atomo HIV Rapid Test being applied onto a finger

Atomo Diagnostics

Atomo Diagnostics HIV Rapid Test

John Kelly shared his dream with us, to improve the way blood was collected and to build a successful medical device company in doing so.

Unilife Safety Syringe

Unilife

Unilife Safety Syringe

When Unilife had the opportunity to develop a safer pre-filled syringe, for a leading pharmaceutical company, we were eager to support them on the journey.

Woman writes note next to truscreen device while in online meeting on computer

Truscreen

Truscreen Cervical Cancer Screening

TruScreen’s technology accurately detects pre-cancerous and cancerous cervical cells and provides immediate, precise results.

man views an image while wearing a viosionsearch bioamplifier

Visionsearch

Visionsearch Bioamplifier

Back on the road, moving forward. It’s full circle for this young Australian company, taking research from the university lab to the market.

child wearing resmed pixi mask holds hose up to camera

ResMed

ResMed Pixi Mask

IDE collaborated with ResMed to develop a sleep apnea mask for kids proving that serious engineering can lead to sweet dreams!

nano-x patient rotation system in a room

Nano-X

Nano-X Patient Rotation System

Designing a cervical cancer screening technology that accurately detects pre-cancerous and cancerous cervical cells and provides immediate, precise results.