Enabling the future of health

SYNTHESIZE

‍We are on a mission to help entrepreneurs build and investors back ventures poised to transform health and medicine

Discover

We unlock the potential of your innovation

As expert navigators of the complex $4 Trillion US healthcare industry, we partner as hands-on interim executives to create a navigable path for US market entry and achieve your first $1mn in revenue applying our cross-functional expertise in product, human factors, market access, FDA regulatory, and Clinical domains.

As consigliere to MedTech and Digital Health startup executives we successfully introduced 10 new products in SaMD, life -sustaining devices, wearables, assistive tech, surgical instruments, Medical XR, and AI in Diagnostics and personalized treatment delivery.
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We helped our clients achieve
4 FDA/Health Canada clearances,
5 ventures hit their first $1mn ARR,
Raise $7mn in capital from grants and VCs,
and contributed towards creating new CMS reimbursement pathways in DME and Category 1/3 codes.

Let's work together

To achieve critical milestones:
Regulatory Authorization
Fundraising
Early Adopter Acquisition
Health Economics and Clinical Outcome Evidence
Product Market Fit

Product & Usability Evaluation

Product feature requirements, and Human Factors and Usability Assessment to attain FDA regulatory readiness and deliver easy-to-use interactions

Market & Regulatory Readiness

Building a product and regulatory roadmap, conduct usability and safety assessments, determine labeling claims to enter the market

Regulatory filing & HIT compliance

FDA and Health Canada regulatory filings,
working as a registered agent, setting up QMS, Health Data Privacy and IT compliance - HIPAA

Market Launch - Early adoption

Working on the pillars of Engagement, Economics, and Evidence through post-market studies to prove effectiveness and economic viability

Market Access & GTM strategy

Identifying revenue pathways, finding reimbursement paths, developing pricing models, customer discovery, customer acquisition

Post market quality & regulatory

Performing FDA quality and IT/AI compliance audits, offer independent assessment on product improvements for continued growth

Our areas of expertise

We focus in the practice areas of of Physical, Occupational and Mental Health, Ambulatory surgery centers (ASCs), Ophthalmology, Neurology, Kidney care, virtual & hybrid models of care delivery, remote monitoring, and population health management.
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Our work spans technologies where IoT expanded reach, miniaturization enabled portability, new digital biomarkers pushed the envelope in diagnostics, human movement analysis helped design next-gen recovery and assistive technologies, and AR/VR devices transformed into a diagnostic, therapeutic & assistive tech.

01.

Digital Health

Enabling a new era of medicine and care delivery

Unearthing medical-grade functions in consumer devices like smartphones, xR devices, and wearables enabled the digital medicine revolution. New regulations from the FDA on SaMD and CMS on interoperability will increase the time to market and the burden of clinical and economic proof different industry stakeholders will seek from digital health startups.
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We work with:
Software-as-Medical-Device (SaMD)
Medical Extended Reality Applications (AR/VR)
Digital Therapeutics (DTx)
Clinical decision support systems (CDSS)
Medical Applications on Consumer Hardware Devices
Medical Device Data Systems (MDDS)

02.

Medical Devices

cutting edge science meets with a changing business landscape

The rapid growth fueled by specialty outpatient & at-home care is bringing a paradigm shift in the design of medical devices. We are transitioning to AI-native medical technology driven by the availability of affordable performance computing. Nearshoring, CHIPs Act, and generative AI will change device companies' operations in the next decade.

We work with:
Neurotechnology
Miniaturized Continuous monitoring devices
Wearables & Assistive technologies
Surgical Innovation to introduce new minimally invasive procedures
Diagnostic Imaging and Imaging guided therapeutics
Portable Life-sustaining devices
Point of care Diagnostics

03.

Health AI

tremendous potential, difficult and complex path to adoption

In a decade, AI will help de-risk drug discovery, speed up device design cycles, reduce workflow friction in clinical settings, personalize treatments, and we will see an explosion of personal health assistants that help with better disease management of individuals and families. This potential comes with new regulatory (FDA, CMS, DHS, FCC, FTC + more) and ethical challenges that builders need to account for in the earliest days of product development. We are involved in policymaking research to allieviate challenges of handling malpractice and economic risk, which is a key barrier to adoption.
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We work with the use of AI in:
Biosignal processing (ExGs) and Imaging
Diagnostics
Decentralized Clinical Trials
Personalized treatment and disease management
Back-office automation
Foundational Vision-Language Models in Medicine
Education and Quality Improvement

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Our Process

Harmonize

Software-as-Medical-Device (SaMD)
Digital Therapeutics (DTx)
Clinical decision support systems Digital Biomarker Discovery
AI in Diagnostics

Synthesize

Durable medical equipment
Consumables
Wearables
Remote Monitoring
Point of care Diagnostics
Drug Delivery devices
Medical Imaging
Surgical Instruments

Galvanize

Ambulatory Surgery Centers
Orthopedics
Rehab technology
Pain Management
Behavioral Disorder Management
Metabolic Disease Management CKD and ESRD Management
Dermatology

3 Areas to focus to succeed in the RTM world

This one is for our entrepreneur friends entering the RTM world. We are entering year 3 of RTM, and in this article, we are unpacking the common challenges in the adoption of Remote Therapeutic Monitoring.

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