Key Takeaways
- The client aimed to develop a DNA/RNA detection technology to improve patient outcomes and promote antimicrobial stewardship.
- Optikos solved the problem by using a gated product development process and a multidisciplinary team to develop an Alpha prototype.
- Within five months, Optikos delivered 15 fully functional demonstrators that were developed in accordance with ISO 13485 standards and continue to be used for ongoing R&D.
- The complex development included thermal controllers, LED based fluorophore excitation, imaging optics, motion control, illumination control, and custom software, with industrial design outsourced to a strategic partner.
- This case study highlights Optikos’ expertise in optical system design and rapid prototyping, as well as its ability to transition projects toward manufacturing.
The Customer
In this case study the client was developing and commercializing proprietary DNA/RNA detection technology. Their goal was to improve patient outcomes and combat antibiotic resistance. In addition, they aimed to promote antimicrobial stewardship in various ambulatory settings including hospital outpatient and emergency departments and long-term care facilities.
The Problem
The client had developed a “proof of concept” breadboard using off-the-shelf components and a mobile phone. However, they lacked the optical engineering or manufacturing capabilities to bring together an Alpha prototype. They approached Optikos to create a more robust design that could serve as both a development platform and a demonstrator system for fundraising efforts. This all needed to be accomplished within a tight timeline.
How Optikos Solved the Problem
Optikos relied on its well-proven, gated product development process for medical devices, along with a dedicated team of full-time engineers (FTEs). These resources allowed them to deliver units for de-risking and further product development. Completing a project of this magnitude within a limited time frame required a robust, multidisciplinary internal team and strategic partners. A wide range of technical functions and skill sets were essential for the project’s on-time completion. These included project management, optical engineering, electronic and electrical engineering, mechanics and optomechanics, and industrial design.
Within the established five-month timeline, Optikos delivered 15 fully functional, highly reliable, long-lasting demonstrators. They progressed from a clean-sheet design to an operational proof of concept. The development process adhered to ISO 13485 standards. The devices continue to function years later and remain in regular use for ongoing R&D.
Optikos managed all aspects of product design, while outsourcing the industrial design to a strategic partner. The instrument development was complex and involved several components. These included thermal controllers, a sample loading mechanism, LED-based fluorophore excitation, imaging optics and camera, a motion controller, illumination control, and custom control software with a graphical user interface (GUI).
Conclusion
This case study demonstrates Optikos’ ability to support optical, illumination, opto-mechanical design, project management, and rapid prototyping of multiple prototypes. These can be rapidly transitioned to manufacturing. Optikos’ ability to design, build, and test all types of optical systems–paired with a robust supply chain with some of the best suppliers in the industry–provided the client with exceptional hardware. This hardware met the specific needs and quality demanded by the client’s specifications.
Whether a client needs an off-the-shelf two-channel fluorescence detection system with a wide range of excitation and emission bands for early de-risking in a rapid turnaround, feasibility for a qPCR product, or ground-up development with the ability to transition its organization to volume manufacturing, Optikos will ensure success.
