Pivot Life Sciences

Medical Device and Life Sciences Development Consulting Services

Fractional, founder, or interim executive functions
Project-based consulting
Milestone-based value creation

Focus Areas

Medical devices
Life sciences treatments and diagnostics
Software, algorithm, AI/ML, data science
Intellectual property
Product development
Clinical trial design and operations
Regulatory strategy

Therapeutic and Technology Specialties

Interventional cardiology
Treatment and characterization of arrhythmias
Drug-device combination products
Non-invasive sensing
Life sciences process tools
Optical methods for chemical analysis and tomography

Our Work

Novel novel AI/ML software as a medical device (SAMD)

Provided fractional CTO for a novel AI/ML software product (SAMD) for dramatic improvement of angiographic imaging
Devised technical strategy for initial market, cultivated and grew intellectual property portfolio, designed and carried out two clinical trials, secured key clinical collaborators, oversaw FDA submission, assisted with fundraising

Coronary imaging catheter based on novel transducer technology

Provided fractional CTO for a startup commercializing an intravascular ultrasound (IVUS) imaging catheter based on technology developed at the Cleveland Clinic
Grew intellectual property portfolio as both co-inventor and portfolio POC, optimized licensing strategy
Pruned and optimized technical plan to achieve successful prototype and acquire preclinical data to support B-round of financing

Direct delivery of next generation metabolic therapeutics

Creation and iterative improvement of design control package to increase chances of regulatory success
Harmonization of fundamental treatment parameters with achievable specifications
Optimization of device visibility on imaging technologies used in minimally invasive procedures