Accelerate Your Medical Device into a Manufactured Product
MEDICAL DEVICES
Focused on the Unique Challenges
of Medical Device Development
PROJECT
Video Laryngoscope
CHALLENGE
Produce a disposable assembly with an inexpensive blind-mate connector meeting the life-expectancy of the re-usable console.
ACCELERATE
A single rigid-flex-rigid PCB-A was designed, leveraging existing cycle-rated PCI connector standards. This extended to an inexpensive image sensor and an LED that doubled as the heat source to defog the window.
RESULT
Our innovative integration of known and novel technologies that kept COGS on target, was readily prototyped and had a robust supply-chain.
PROJECT
Surgical Robot Manufacturing for Engineering Qualifications
CHALLENGE
Concurrently complete the design of a complex re-sterilizable articulation and visualization assembly while generating the test and assembly fixtures.
ACCELERATE
Created nine independent assembly stations, established in-process test parameters, created Work Instructions, and trained the staff.
RESULT
Successfully built units for evaluation and clinical trials under ISO13485 certifications.
PROJECT
Auto-Injector Evaluation
CHALLENGE
Evaluate an Auto-Injector Pen for use in a new micro-dose application for a fortune 100 pharmaceutical company
ACCELERATE
Analyzed the existing mechanical design. Applying tolerance analysis theory, the best expected performance was calculated and compared physical testing to ISO 11608 protocols.
RESULT
Calculations were validated by empirical data proving micro-injections could not be accommodated without redesign.
PROJECT
Dental Tip for 3D-laser Scanning System
CHALLENGE
Design a low-cost disposable with an interferometric grade electrically heated mirror for digital impression system.
ACCELERATE
Engineered an architecture that took advantage of laminar construction manufacturing, large-sheet materials, low-cost active circuitry and low-cost processing.
RESULT
Successfully sold and manufactured for several years. Met COGS expectations to avoiding offshoring by a novel introduction of materials that passed cytotoxicity testing.
PROJECT
Surgical Robot Test & Assembly Stations
CHALLENGE
Develop a disposable surgical robot manufacturing line for transfer to a Contract Manufacturer.
ACCELERATE
Developed multiple assembly & test stations after determining the optimal process flow. Developed procedures, training, qualifications and calibrations.
RESULT
Kicked-off a successful manufacturing line that produced units for clinical trials.
PROJECT
Ergonomics and Usability of Electro-Mechanical Auto-Injector
CHALLENGE
Ergonomics Studies indicated users preferred a different device orientation than the device that was in the middle of its design cycle and needed to be rapidly changed to lessen schedule impact.
ACCELERATE
Rapid prototyped a functional unit to confirm User-Study’s claims. Impact to current design was evaluated to determine how to minimize changes. Design was expedited and quickly developed concurrently and in parallel to the ongoing development.
RESULT
We successfully pivoted a key parameter of the device. With an accelerated design cycle, the changes were made and merged into the ongoing design with minimal impact to the overall schedule.
I am always impressed by the depth of knowledge Jason has about the larger process of developing a new product. As a medical doctor, I deeply value not only knowledge but the ability to communicate that knowledge in understandable terms. Jason went far beyond my expectations of Gathering resources in the Boston area and recognition of the best strategic partners for the Alzheimer’s eye-tracking device.