Enabling the future of health

SYNTHESIZE HEALTH

We help innovators and entrepreneurs overcome product design, regulatory, commercialization, and clinical adoption challenges to build transformative health technology ventures

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 implement targeted operational frameworks that best fit a venture

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

05.
Investors

Investors

Automates key business processes across company departments

Investors
04.
Enterprise

Enterprise

Plan, track, and manage business projects, resources, and budgets

Enterprise
03.
Scale-up

Scale-up

Streamlines financial management tasks, such as invoicing and reporting

Scale-up
02.
Growth

Growth

Schedule, manage, and track employee time and attendance

Growth
01.
Pre-revenue

Pre-revenue

Secure and user-friendly platform to sell products and services

Pre-revenue

we HELP

Build engaging products
Achieve market adoption

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, fasten 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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Work with us

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

3 Areas to focus to succeed in the RTM world

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.

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

Sent!

Thank you for your interest.

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Enabling the Future of Health

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8

Health technology
products launched

100%

Cleared through
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in first Attempt

3

3 FDA or Health Canada
cleared products
launched since 2020

01.
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Emphasize on our experience

Design refer to the process of conceptualizing, planning, and executing visual elements.

Our services

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Highlight the services offered

Design play a critical role in shaping a brand’s identity, as well as influencing its performance in the marketplace.

Our solutions

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About company

We understand that design services are an essential aspect of modern-day business operations.

About us

04.

Professionals

Professional design services help to convey a sense of professionalism and expertise to your target audience.

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Services

Product

Product

Build clinically effective, safe, easy-to-use products and manage them throughout their lifecycle

01.
Go to Market

Go to Market

Build a sustainable business model and partnerships to achieve market adoption and build a sustainable business

02.
Regulatory

Regulatory

Your optimal regulatory strategy to launch your product, scale your business, and become profitable

03.
Health Tech Insider
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Business articles
3 Areas to focus to succeed in the RTM world
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.

Read Article

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