Accelerate Your Medical Device into a Manufactured Product

MEDICAL DEVICES

Focused on the Unique Challenges
of Medical Device Development
medical devices 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

surgical robot manufacturing for engineering qualifications for medical device development

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

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.

Dr. Cary Fechter, MD

CEO, Quality Of Life Innovations