Increasing Commercial Success of Genomic Startup with Breakthrough Technology
The innovation of genetic analysis tools and platforms is revolutionizing the traditional practice of medicine, improving reproductive care, and enabling earlier disease detection. This all results in improved patient care and human health. One of the fast-growing areas in the field of molecular diagnostics is Next Generation Sequencing (NGS), providing detailed genomic information.
The goal was to increase the overall robustness of the design, enhance reliability, and transfer the unit into BIT manufacturing to allow a fast production ramp-up upon launch.
In 2019, the molecular startup company, Miroculus, and BIT partnered to commercialize their proprietary NGS library prep platform, Miro Canvas. The goal was to increase the overall robustness of the design, enhance reliability, and transfer the unit into BIT manufacturing to allow a fast production ramp-up upon launch. Miroculus launched the first beta units in Q4 2020, and the commercial launch is slated for Q4 2021 for Research Use Only. Compared to other library prep platforms available on the market, Miroculus’ innovative solution is fully automated and flexible providing great benefit for laboratories of all sizes.
- Providing Confidence to Investors
Miroculus was looking for an experienced full-service partner to support the design, development, technology transfer, and scale-up of their cutting-edge technology. To support the commercialization of future product launches and give confidence to investors, Miroculus needed additional regulatory guidance.
- Boosting Market Access and Increasing Commercial Success
Miroculus needed engineering support to make the prototype design robust to increase usability and overall manufacturability. In addition, the existing production costs (e.g., material/labor costs) did not meet the required cost structures for the intended market and had to be value-engineered for Miroculus to be competitive and commercially successful.
- Manufacturing Excellence and Technical Service Capabilities
As a startup company, Miroculus did not have the necessary in-house capabilities and experience to manufacture their products at scale and cost. The initial prototype was not yet optimized to be manufactured at a larger scale. Instead of using limited internal manufacturing resources, the best option was to outsource the project to a reliable, experienced, and flexible partner with proven operational capabilities.
Miroculus needed engineering support to make the prototype design robust to increase usability and overall manufacturability.
< 3 mos.
Rapid Phase 0 DFM Analysis
Production Costs Decreased
Assembly Time Shortened
- Joint Step-By-Step Approach for Innovative Biotech Startups
By applying this business model to the Miroculus project, BIT identified and solved many technical challenges from design transfer to production under budget all within a tight timeline.
- Leveraging BIT’s Cost Down Program to Increase Commercial Success
BIT proposed a full Design for Manufacturing (DFM) analysis to decrease manufacturing costs, enhance prototype manufacturability, and ensure a smooth transfer into manufacturing. BIT identified a cost-down program, starting with a detailed bill of materials (BOM) analysis to identify the main cost drivers on a part and commodity level. BIT was able to significantly reduce unit costs by 15%. Through these design decisions, BIT increased the overall robustness of the system, which ultimately enhanced the reliability and consistency of the device. These product improvements and cost savings created a competitive product for Miroculus.
- Experience as Full Life Cycle Support Partner: Design, Manufacturing, Technical Service and End of Life Management
By working with BIT, Miroculus was able to leverage BIT’s experience and significantly decrease manufacturing costs. In addition, BIT’s global footprint and more than 130,000 ft2 of floor space can support Miroculus in their future growth while allowing some flexibility in terms of an adjusted forecast. Miroculus now has a reliable partner to collaborate with for future innovative projects.
BIT was able to significantly reduce unit costs by 15% and increased the overall robustness of the system.
- 150 Engineers and Scientists Holding over 30 Internal Patents – Systems, Software, Electronics and Mechanic Engineers with vast knowledge in a broad variety of technologies receive continuously updated training in spaces like market regulatory requirements, risk management, and design processes to ensure they are leaders in their space. Our patents can be utilized by clients to accelerate time to market and to add additional beneficial features to their products.
- 43 Years of Excellence with More Than 190,000 Instruments on the Market – Our competency is evident in our long-term manufacturing relationships with industry leaders like Siemens, Abbott, Beckman Coulter.
- We Speak Regulatory – With an in-house regulatory team and all BIT manufacturing facilities operating under ISO 13485 and FDA certifications we ensure our customers are planning and achieving all relevant regulatory requirements.
- Long-lasting Team Collaboration – We have over 95% full-time employee’s with low turnover rates and long work relationships in our engineering and manufacturing department. This allows working together with a stable and consistent project team throughout development and manufacturing.
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