A lab technician in a white coat holds blood samples near laboratory equipment, showcasing the legacy IVD product modernization process while ensuring 510(k) compliance.

IVD Platform Refresh

Client

Fortune 500 IVD Company

Challenge

Our client faced the obsolescence of critical components within a legacy IVD product platform, including single-board computers and microcontrollers. A lack of original firmware source code and the sunsetting of institutional knowledge required extensive reverse engineering before updates could be designed and implemented. Adding further complexity, Triple Ring was tasked with modernizing the product to maintain market competitiveness yet demonstrate equivalence to fulfill the criteria of a Special 510(k) regulatory pathway.

 

Outcomes

A full system design and regulatory package was delivered for a refreshed IVD product with demonstrated equivalency to its FDA-cleared predecessor. Triple Ring replaced obsolete components, reverse-engineered and migrated existing software to a new OS, updated subassemblies, and developed new firmware compatible with legacy systems. The refreshed system featured modern industrial design, met manufacturing cost targets, and integrated seamlessly with existing manufacturing processes, ensuring uninterrupted production.

 

Value Propositions

  • Multidisciplinary teams skilled in reverse engineering and future-proofing
  • Software porting expertise
  • In-depth knowledge of clinical IVD devices and relevant regulatory requirements
  • Strong collaboration with client manufacturing and service teams
  • Industrial Design capabilities to modernize user experience
Close-up of a computer hard drive circuit board, showcasing blue circuitry and an attached circular component with orange connectors, reminiscent of the precision needed in legacy IVD product modernization and 510(k) compliance.
A person is sitting at a desk using a laptop and monitor, both displaying lines of code. A tablet with a blank page is also on the desk, suggesting plans for legacy IVD product modernization.

Background

A large multinational corporation specializing in In Vitro Diagnostic (IVD) devices engaged with Triple Ring to refresh and future-proof a legacy product line facing component and software obsolescence. Triple Ring executed an accelerated program to modernize the platform while holding production costs steady and demonstrating equivalent performance.

Two medical professionals examine brain scans on monitors. A patient lies on a CT scanner in the background.

Maximize Legacy Product Value

Client

Large Corporations

Background

Sustaining engineering is more than product maintenance and implementing market requests; it’s a strategic approach to keeping legacy products competitive and profitable over decades. At Triple Ring, we don’t simply maintain legacy products – we transform them to meet modern demands.  We add high-value features like AI in addition to updating industrial design, increasing reliability, and lowering production costs.  We also address evolving regulatory risk, including cyber security, while carefully protecting core intellectual property.

Modernization of Legacy Products

Keeping products ahead in the market through:

  • AI design and integration
  • Cybersecurity software migrations
  • Performance upgrades and added functionality
  • Refreshed industrial design, usability, and aesthetics
  • Supply chain security
Soldering prototype PCBA board.
A scientist uses a pipette in a lab, with DNA sequences displayed on a screen in the background.

AI Enhancement

Enhancing legacy systems with physics-based AI improves performance, accuracy, and efficiency, and supports predictive maintenance. These features dramatically extend product lifespan without costly hardware upgrades. Triple Ring has the experience and expertise in AI algorithm design and integration to modernize products and create new valuable solutions for customers.

Supply Chain Optimization

Updating and optimizing supply chains addresses obsolescence, reduces cost, increases production yields and product reliability. Triple Ring and our partners ensure smooth production, minimize disruptions, and unlock new cost-saving opportunities for your legacy products.

Why Partner with Triple Ring?

Successful products often outlive the teams that launched them resulting in critical knowledge gaps within organizations that grow over time.  Product companies need a trusted partner with deep expertise in reverse engineering, modern regulatory standards, supply chain access, and expertise in AI.  Partnering with Triple ring unlocks these benefits, and importantly, saves product companies the cost and schedule delays associated with rebuilding engineering teams.  Ensure product success and optimal return on investment over the long haul by engaging with Triple Ring on your next sustaining engineering project.