Partisan. Healthcare Advisory
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Irvine, California · Global Healthcare Advisory

Bringing breakthroughs to life.

Partisan Healthcare Advisory takes Healthcare companies from clinical study to commercial scale across every major geography — accelerating time to market while cutting cost, so innovations that benefit millions actually reach them.

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One partner, the full pathway

From first study to first sale

01
Clinical Studies
Low-cost, high-speed trials to unlock regulatory and commercial approval.
02
Supply Chain
Manufacturing transfer to cut COGS, capital outlay, and tariff exposure.
03
Commercialization
Regulatory approvals and a built-to-fit commercial channel that sells.
80+
Combined years of device commercialization at the founder level
50+
Countries covered by regulatory & distribution partners
40+
Investigator sites via our India clinical organization
~90%
Lower patient-recruitment cost vs. US in select markets*
9
Manufacturing geographies across our CMO network
Who we are

A global commercialization partner, run by operators.

Partisan Healthcare Advisory LLC is an Irvine, California based management consulting firm focused on healthcare commercial-channel development, clinical studies, and supply-chain optimization.

We help healthcare companies accelerate time to market while reducing overall cost. That often starts with high-speed, low-cost clinical studies paired with the right supply-chain partner — and extends through local regulatory approvals and a purpose-built commercial channel in every major market.

Our leadership has run cardiology for Baxter in Japan, all of Asia for Edwards Lifesciences, and taken multiple startups from inception to full global launch. On the ground in India, we operate through our majority-owned company, Indical MedSurg — giving clients a direct clinical and commercial organization, not a chain of subcontractors.

See what we do →
Headquarters
Irvine, California, USA
Focus
MedTech clinical, supply chain & commercialization
Geographic reach
US · Europe · LatAm · India/SE Asia · Africa–ME · North Asia
India delivery arm
Indical MedSurg (majority-owned)
Manufacturing network
9 countries, incl. US FDA-registered CMOs
Regulatory coverage
Partners across 50+ countries
What we do

One partner, the entire pathway to market

Everything a healthcare company needs to reach and scale a new market — a product's actual route from first study to first sale, handled end to end.

Clinical Studies

A full clinical organization to run device trials fast and affordably — from First-in-Human through pivotal and registry studies, structured to support both regulatory approval and commercial adoption.

  • First-in-Human and formal regulatory trials
  • 40+ investigator sites, fast IRB/ethics approvals
  • Data management, medical writing, registries
  • India data positioned for FDA IDE/PMA inclusion

Supply Chain

Choosing the right contract manufacturer reshapes your economics — lowering cost of goods, capital outlay, import tariffs, and time to market. We manage transfer, validation, and second-source setup end to end.

  • Manufacturing transfer & design-for-manufacturing
  • CMO partners in 9 countries incl. US FDA-registered
  • Second-source validation & ongoing value engineering
  • Manage long-term or transfer to you when ready

Commercialization

Regional sales-channel managers in every major market build the go-to-market that fits your product — direct sales force, distribution network, or hybrid — then run it or hand it over.

  • Regional channel leads: US, EU, Japan, China, India, Africa–ME, LatAm
  • Local regulatory approvals to unlock revenue
  • Bespoke direct, distributor, or hybrid channels
  • Long-term management or clean transfer at exit
Track record

Proof, not promises.

The innovations we back are among the most inventive in healthcare. Names are withheld at our partners' request — the work speaks for itself.

1st
First-in-Human robotic surgery evaluation delivered in India
2–3 mo
Typical regulatory approval when the dossier is in order
Up to 50%
Manufacturing cost reduction via network CMOs
30+
Countries that honor Indian commercial approval
Case study · Surgical Robotics

UK robotics innovator, first-in-human in a new region

1stFirst-in-Human robotic surgery of its kind, on an aggressive timeline
The challenge. A UK-based surgical-robotics company needed a trusted partner to navigate regulatory approvals, stand up a local legal entity, run a first-in-human robotic surgery evaluation, and open a commercial pathway across the Asia–Middle East–Africa region — all against a tight clock.
What we did. Through our India organization, Indical, we acted as the on-the-ground Authorised Representative, managed every regulatory submission, established the client's local entity, coordinated the first-in-human evaluation across top surgical centers, and activated the AMEA commercial distribution channel.
First-in-Human Regulatory Entity formation AMEA commercial
Case study · Structural Heart

Structural-heart pioneer, a world-first polymer valve

1stFirst commercially available polymer heart valve, brought to the world
The challenge. A structural-heart innovator had developed a polymer heart valve with the potential to reach the millions of patients who can't tolerate today's tissue or mechanical options — and needed a fast, rigorous clinical pathway to prove it and open the route to first commercial approval.
What we did. Operating the innovator's own India entity, our India organization, Indical, ran the polymer heart-valve clinical study end to end — leading clinical operations and coordinating leading cardiac centers — supporting the path to the world's first commercially available polymer heart valve.
Polymer heart valve Clinical study Structural heart World first
Technologies we've advanced

Breakthrough devices, carried to market

A sample of the categories we've supported across clinical, regulatory, manufacturing, and commercial workstreams.

Structural heart

Polymer Heart Valves

Urology

Microbubble Kidney-Stone Therapy

Robotics

Robotic Dental Surgery System

Robotics

Robotic Surgical System

Visualization

4K ICG Visualization System

Endoscopy

Panoramic Endoscopic Visualization

Leadership

Global MedTech operators, not career consultants

The people who will run your program have built channels, transferred manufacturing, and launched devices across the world.

Brad Sharp

Founding Partner
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Brad Sharp

Brad Sharp

Founding Partner

41 years in high tech, the last 25 as a medical-device CEO. Ran cardiology for Baxter CVG in Japan and all of Asia for Edwards Lifesciences, and brought two startups from inception to full global launch. Degree in applied physics; speaks Spanish, Korean, and Japanese. Based in Irvine, CA.

LinkedIn ↗Email

Laxmi Khanolkar

Founding Partner
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Laxmi Khanolkar

Laxmi Khanolkar

Founding Partner

41 years of pharma and medical-device commercialization. Has built distribution networks in every major market — including the US — and multiple direct sales forces in India. A recognized expert in establishing commercial channels across South Asia and Africa–ME. Based in Mumbai, India.

LinkedIn ↗Email

Andrew Sharp

VP Technology
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Andrew Sharp

Andrew Sharp

VP Technology

Biomedical engineer with deep experience in design, design-for-manufacturing, overseas manufacturing transfer, and value engineering. Former VP of R&D at Integrated Endoscopy, where he led transfers to China, Taiwan, India, and the DR. Heads the global technical function. Based in Irvine, CA.

LinkedIn ↗Email

Dr. Manisha Jadhav

VP Clinical
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Dr. Manisha Jadhav

Dr. Manisha Jadhav

VP Clinical

15+ years in clinical research and global operations. Former Global VP of Clinical & Operations at Integrated Endoscopy and India Clinical Manager at Foldax, with a strong record building clinical, regulatory, and operations teams across therapeutic areas. Core expertise in India and Africa–ME. Based in Pune, India.

LinkedIn ↗Email

Abhishek S. Padmanabhan

Finance Lead
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Abhishek S. Padmanabhan

Abhishek S. Padmanabhan

Finance Lead

15+ years in accounting, financial management, and corporate administration in the medical-device sector. Leads finance and corporate operations at Indical — foreign-investment and ECB structuring, statutory compliance, and commercial finance for market entrants — with prior roles at Insightra Medical and CMR Surgical. B.Com in Accountancy; MBA in Corporate Finance. Based in Goa, India.

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Shruti Bhat

RA/QA & Manufacturing Lead
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Shruti Bhat

Shruti Bhat

RA/QA & Manufacturing Lead

Leads regulatory affairs, quality assurance, and manufacturing at Indical. Manages CDSCO and MD-15 submissions, quality-management systems, and the local production and sterilization partnerships behind device manufacturing and import in India. Based in India.

Email
How we work

From first conversation to commercial success

A guide, not a rulebook — we adapt each step to your product, timeline, and commercial goals.

STEP 01

Discovery Call

We learn your product, therapy area, target markets, and commercial goals.

STEP 02

Strategy & Pathway

A tailored market-entry plan: regulatory route, clinical strategy, and channel model.

STEP 03

Agreement

NDA and service agreement executed — scope, timelines, and terms agreed.

STEP 04

Regulatory Submission

We prepare and file applications with the relevant health authorities.

STEP 05

Clinical Execution

Where required, our clinical organization runs trials or registry studies.

STEP 06

Commercial Launch

Approval secured, distribution activated, first sales and ongoing support.

Trusted partners

A vetted network behind every engagement

Beyond in-house resources, we activate specialist partners by region and need — anchored by our own India organization.

● Majority-owned · India delivery arm

Indical MedSurg Pvt Ltd

Mumbai, India · Founded 2012

Our on-the-ground organization in India and the single-window partner for healthcare companies entering the region. Indical combines a full-service CRO, regulatory representation, local manufacturing, and pan-India distribution under one roof — so clients get a direct clinical and commercial team, not a chain of subcontractors.

Visit Indical ↗
40+
Investigator sites for device trials
2012
Serving foreign healthcare entrants since
CRO
Full-service: FIH to registries, data & medical writing
IAR
Authorised Indian Rep: MD-15 import & CDSCO strategy

Strategic Partner

US FDA-registered, ISO-certified manufacturing partner in Gujarat's device cluster — ETO sterilization and ISO Class 7 cleanroom production, with duty-free import/export pathways and up to 50% cost reduction.

Manufacturing network

CMO partners across the US, Japan, China, Singapore/Malaysia, Thailand, India, Brazil, Mexico, and the Dominican Republic.

Regulatory partners

Specialist regulatory partners spanning 50+ countries to secure approvals and unlock revenue in each target market.

Distribution & talent

Distribution partners in every region across a wide range of clinical indications, plus HR and fractional-management partners in major markets.

Get in touch

Ready to reach your next market?

Tell us about your device and where you want to take it. We'll come back with a candid view of the pathway, timeline, and cost.

Global Headquarters
Partisan Healthcare Advisory LLC
8 Japonica
Irvine, CA 92618, USA
C/o: Brad Sharp - FOUNDING PARTNER

T: +1-949-892-7812
E: brad@partisanmed.com
India Operations · Indical MedSurg
Mumbai, India
A/4, Ground Floor, Vile Parle Colony CHSL,
Sahakar Road, Vile Parle (East), Mumbai – 400057
C/o: Dr. Manisha Jadhav - VP CLINICAL AFFAIRS

E: manisha@indicalmed.com
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Or email us directly at brad@partisanmed.com