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Enabling the future of health
SYNTHESIZE
We help innovators and entrepreneurs build transformative health technology ventures by overcoming product design, regulatory, market access, and clinical and consumer adoption challenges
Unlock the potential of your innovation
At Synthesize, our mission is to help entrepreneurs build and investors back the next era of ventures poised to transform health and medicine.
We are a team of experienced Medical Device and Digital Health venture builders with a history of successful FDA and non-FDA regulated product launches.
We come in as strategic consultants and interim functional executives in product, commercialization, quality & regulatory, and clinical to solve critical product and business challenges for ventures working on new initiatives.
Our work resulted in 10 health technology product launches ranging from endoscopy products to VR for behavioral disorders and rehabilitation. We helped our clients achieve 3 FDA clearances, hit 7-figure ARR, and contributed towards creating new CMS reimbursement pathways.
Let us help you launch your transformative venture!
we work with
Digital Health, Medical Device, and Health AI ventures
at different levels of maturity
Pre-revenue
SEED STAGE
GOAL: Successfully launch your first commercial product
Growth
SERIES A/B
GOAL: Achieve product market fit and become profitable
Scale-up
SERIES C+
GOAL: Launch your next act, expand your reach
Enterprise
MEDTECH & DIGITAL HEALTH
GOAL: Successful launch of new product initiatives
OUR OFFERING
Build engaging products
Achieve market adoption
Succeed in the US market
We help entrepreneurs find a navigable path towards building a successful company with clinically validated products. There are four major obstacles that hinder product adoption for health tech ventures
Need for higher quality clinical evidence
Product design issues leading to low user engagement
Misaligned incentives across stakeholders
Lobbying & highly fragmented gatekeeper economy
Our expertise, experience, and vetted ecosystem can help you overcome those obstacles.
Our areas of expertise
We have a history of product and service launches in the areas of Physical, Occupational and Mental Health, Ambulatory surgery centers (ASCs), Kidney care, virtual & hybrid models of care delivery, remote monitoring, and population health management.
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 xR head mounted displays transformed into a diagnostic & therapeutic devices.
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.
We work with:
Software-as-Medical-Device (SaMD)
Medical Extended Reality Applications
Digital Therapeutics (DTx)
Clinical decision support systems (CDSS)
Digital Biomarker Discovery
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:
Durable & consumable medical equipment
Wearables & Assistive technologies
Point of care Diagnostics
Surgical Robotics and Minimally invasive surgical products
Medical Imaging
Imaging guided therapeutics
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 work with the use of AI in:
Biosignal processing
Observability of devices and IT
Computer Aided Detection and Diagnostics
Population Health and Practice Management
Physical Medicine and Rehabilitation
Domain specific foundational LLMs
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
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Let's work together
We share your vision to:
Build in-house capabilities
Ensure safety & clinical effectiveness
Provide best-in-class user experience
Cultivate partnerships for sustainable growth
Deliver on the promise of good health
Targeted
We are the opposite of one-size-fits-all, our recommendations are based on your product, regulations, resources and market conditions
Bias towards action
We are fast learners and we roll up our sleeves to put our recommendations into action together with your team, in a matter of few weeks
In it for the long run
We focus on frequent Iteration of the product and business models to create and capture more value per $ spent.
Access to ecosystem
Our 600+ expert ecosystem consists of investors, doctors, clinical scientists, practice owners, quality, regulatory, and manufacturing experts
Focused and Exclusive
We commit to very few projects each year to stay focused on the quality of our output and to maximize the value our ecosystem can offer
Only available to newsletter subscribers!
Let's Connect
01.
Say Hello
Mon - FRI - 8 AM - 7 PM Eastern time
02.
Drop us a line
Tell us what you are building and where you need help
Enabling the Future of Health
Home
8
Health technology
products launched
100%
Cleared through
regulatory bodies
in first Attempt
3
3 FDA or Health Canada
cleared products
launched since 2020
01.
Emphasize on our experience
Design refer to the process of conceptualizing, planning, and executing visual elements.
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02.
Highlight the services offered
Design play a critical role in shaping a brand’s identity, as well as influencing its performance in the marketplace.
03.
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About company
We understand that design services are an essential aspect of modern-day business operations.
04.
Services
US Market Access to Success
Build clinically effective, safe, easy-to-use products and manage them throughout their lifecycle
01.
AI Research to Revenue for Health Systems
Build a sustainable business model and partnerships to achieve market adoption and build a sustainable business
02.
Deal Sourcing and Diligence for VC/PEs
Your optimal regulatory strategy to launch your product, scale your business, and become profitable
03.
Health Tech Insider
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