BIOMEDICAL OVERVIEW Biomedical Research and Diagnostics Boston Engineering solves complex product Boston Engineering applies its phase-gate development and engineering challenges for development process to: biotherapeutics, diagnostics, and medical devices • Mitigate risk organizations. Our multidisciplinary teams combine • Optimize for manufacturability and service innovative thinking with the technical and regulatory • Comply with stringent regulatory requirements experience to drive product success. • Accelerate time to market Our Impact: Accelerate Genomics Engineering from Months to Days Background: Researchers needed to speed up complex manual DNA engineering to synthesize genomes for therapeutics and other applications Results: Developed an automated genomics research system to: • Perform 50 different genome alternations at nearly the same time • Generate billions of different mutant genomes per day • Scale the bench-top system from targeted research to commercially licensed technology Our Impact: • Cut cycles significantly. Example: created a target bacteria variation in three days that would have taken months manually • Translated laborious and expensive research into a configurable automated processes • Developed novel technologies: ▪ Workflow (sequencing, timing, prioritization) ▪ End effectors with robotic arm (speed, precision, handling, cleaning, and safety) ▪ Incubation chamber (thermal management) Process Overview: ▪ Filtering (safety, sample collection) 1) Grow cells, induce expression, and chill ▪ Fluid pathway (precision, volume) 2) Filter media, add oligos to washed cells ▪ Graphical user interface (ease of use) 3) Deliver oligos into cells, recover cells The Boston Engineering Advantage Boston Engineering develops novel technology for Biomedical Engineering: commercialization that improves how people work • Design for manufacturability and assembly and live. Examples: (DFM&A) Precision: Examples include: • Integrate novel technology with commercial- • Conduct DNA-level genome editing off-the-shelf (COTS) products to accelerate • Generate samples 20 nanometers thin – the development, reduce costs equivalent to slicing the width of a human hair • Micro fluidics: dispense, handle, and transfer into 4,000 sections • Thermal management and control Automation and Performance: • Kinematics modeling (control systems) • Cut testing cycles from months to days, • Software and GUI development or days to hours Connected Capabilities: • Automate and control manual research • Internet of Things (IoT) processes that are slow and costly • Augmented Reality (AR) • Enable sophisticated sequencing, timing, Compliance: and prioritization • ISO 13485:2016-certified design control • Run experiments 24/7 for weeks procedures • Maintain precise temperature, environmental Application of device design standards requirements • including IEC 62304, IEC 62366, and Diagnostics: IEC 60601 • Laboratory and point-of-care applications • Disposable cartridge development: design through commercialization and support About Boston Engineering Boston Engineering provides product design and engineering consulting from concept through commercialization and connectivity. Boston Engineering is also the Northeast’s largest PTC software reseller and is a ThingWorx IoT partner. Certified for ISO 9001 and ISO 13485, the com- pany’s industry expertise includes commercial, Contact us: defense, and medical. Founded in 1995, Boston boston-engineering.com Engineering is headquartered in Waltham, Mass. [email protected] 781-466-8010 © 2018 Boston Engineering Corporation. All rights reserved. Boston Engineering and Imagine the Impact are trademarks of Boston Engineering Corporation. All other brand or product names are trademarks or registered trademarks of their respective owners. CM180930v1.