BIOMEDICAL OVERVIEW - Boston Engineering · 2018-10-03 · • Integrate novel technology with...

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Boston Engineering solves complex product development and engineering challenges for biotherapeutics, diagnostics, and medical devices organizations. Our multidisciplinary teams combine innovative thinking with the technical and regulatory experience to drive product success. Boston Engineering applies its phase-gate development process to: Mitigate risk Optimize for manufacturability and service Comply with stringent regulatory requirements Accelerate time to market Biomedical Research and Diagnostics BIOMEDICAL OVERVIEW 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) Filtering (safety, sample collection) Fluid pathway (precision, volume) Graphical user interface (ease of use) Process Overview: 1) Grow cells, induce expression, and chill 2) Filter media, add oligos to washed cells 3) Deliver oligos into cells, recover cells

Transcript of BIOMEDICAL OVERVIEW - Boston Engineering · 2018-10-03 · • Integrate novel technology with...

Page 1: BIOMEDICAL OVERVIEW - Boston Engineering · 2018-10-03 · • Integrate novel technology with commercial-off-the-shelf (COTS) products to accelerate development, reduce costs •

Boston Engineering solves complex product development and engineering challenges for biotherapeutics, diagnostics, and medical devices organizations. Our multidisciplinary teams combine innovative thinking with the technical and regulatory experience to drive product success.

Boston Engineering applies its phase-gate development process to:• Mitigate risk• Optimize for manufacturability and service • Comply with stringent regulatory requirements• Accelerate time to market

Biomedical Research and Diagnostics

BIOMEDICAL OVERVIEW

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) ▪ Filtering (safety, sample collection) ▪ Fluid pathway (precision, volume) ▪ Graphical user interface (ease of use)

Process Overview: 1) Grow cells, induce expression, and chill2) Filter media, add oligos to washed cells3) Deliver oligos into cells, recover cells

Page 2: BIOMEDICAL OVERVIEW - Boston Engineering · 2018-10-03 · • Integrate novel technology with commercial-off-the-shelf (COTS) products to accelerate development, reduce costs •

About Boston EngineeringBoston 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, defense, and medical. Founded in 1995, Boston Engineering is headquartered in Waltham, Mass.

© 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

Contact us:[email protected]

The Boston Engineering AdvantageBoston Engineering develops novel technology for commercialization that improves how people work and live. Examples:

Precision: Examples include:

• Conduct DNA-level genome editing

• Generate samples 20 nanometers thin – the equivalent to slicing the width of a human hair into 4,000 sections

Automation and Performance:

• Cut testing cycles from months to days, or days to hours

• Automate and control manual research processes that are slow and costly

• Enable sophisticated sequencing, timing, and prioritization

• Run experiments 24/7 for weeks

• Maintain precise temperature, environmental requirements

Diagnostics:

• Laboratory and point-of-care applications

• Disposable cartridge development: design through commercialization and support

Biomedical Engineering:

• Design for manufacturability and assembly (DFM&A)

• Integrate novel technology with commercial-off-the-shelf (COTS) products to accelerate development, reduce costs

• Micro fluidics: dispense, handle, and transfer

• Thermal management and control

• Kinematics modeling (control systems)

• Software and GUI development

Connected Capabilities:

• Internet of Things (IoT)

• Augmented Reality (AR)

Compliance:

• ISO 13485:2016-certified design control procedures

• Application of device design standards including IEC 62304, IEC 62366, and IEC 60601