Since 2012 · Mumbai, India

From global innovation to India's next breakthrough

We take pioneering MedTech companies from first consultation to sustained growth in India — guiding you through every gateway: clinical study, commercial launch, and local manufacturing. One partner, the entire climb.

Global Innovators Indical Consultation 1 · Clinical Study 2 · Commercial Launch 3 · Local Manufacturing Sustained Growth & Profitability
$18B+
India MedTech market in 2026, ~8% CAGR
12x
Lower operating & labour cost vs. USA
8.2%
Share of global economy (PPP)
10×
Lower clinical trial costs vs. US/EU
Top 20
Global medical device market · #4 in Asia
Who We Are

India's most comprehensive MedTech partner

Founded
2012
Headquartered
Mumbai, India
Majority Shareholder
Partisan Healthcare Advisory (Irvine, CA)
Specialties
All Medical Device Specialties
Network
India, Middle East & Africa
Global Access
Via Partisan's Network — USA · Europe · LatAm

Indical MedSurg Pvt Ltd is the India-based MedTech commercialisation company majority-owned by Partisan Healthcare Advisory, Irvine, California. Indical's own operations are focused on India, the Middle East and Africa — and through Partisan, Indical clients gain access to Partisan's wider global network across the USA, Europe, and Latin America.

Since our founding in 2012, we have been the trusted single-window partner for foreign MedTech companies entering India — combining regulatory expertise, clinical research, local manufacturing, and distribution under one roof. Thirteen-plus years navigating India's complex MedTech regulatory landscape means global standards, deep local expertise, and real commercial results.

The only advisory in India combining CRO + Regulatory + Manufacturing + Distribution under one roof
We don't just process paperwork — we serve as strategic advisors, bringing global executive experience to optimise revenue and the bottom line
Specialising in emerging markets, where friction is highest and ROI potential is unmatched
Our Four Service Pillars

One partner, the entire pathway to market

Everything a foreign MedTech company needs to succeed in India — a product's actual route from first study to first sale, handled end to end.

01 / Clinical Research (CRO)

Full-service CRO

FDA projects, fast IRB approvals, 40+ investigator sites, expert data management and medical writing — from First-in-Human studies to registries.

#1 Revenue Driver
02 / Market Entry & Regulatory

Authorised Indian Representative

MD-15 import licensing, CDSCO submissions, complete regulatory strategy, dossier preparation, and local entity formation.

#2 Key Differentiator
03 / Local Manufacturing

Strategic manufacturing

Partnership with Dolphin LifeScience (US FDA registered, ISO certified) — full ETO sterilisation and ISO Class 7 cleanroom production.

#3 Cost Advantage
04 / Distribution & Sales

Pan-India commercial channel

Experienced sales force, KOL relationships, and Partisan's global network activate the market once approved.

#4 Market Reach

Clinical Research — the numbers

67+
FDA projects
40+
Investigator sites
5+
Registry studies
3,500+
Registry patients
89%
Registry compliance (vs. 67% industry avg.)
3 mo
Approval process (vs. 6 mo industry avg.)
4 mo
Review process (vs. 9 mo industry avg.)
10×
Lower trial costs vs. US/EU

Your regulatory pathway into India

Option A

Standard Pathway

12–18 months
  • Set up Indian legal entity yourself
  • MD-15 import licence under own name
  • Build own sales infrastructure
  • Higher upfront cost & longer timeline
  • But the greatest control
Option C

Local Manufacturing

5–9 months
  • Manufacturing transfer to Dolphin (Class A–D)
  • MD-5 / MD-9 CDSCO licensing
  • Duty-free COGS optimisation
  • Lowest cost, strongest pricing advantage

Local manufacturing — Dolphin LifeScience

Gujarat's prominent medical device cluster, with free-zone duty-free import and export pathways — up to 50% manufacturing cost reduction.

Certifications & Registrations
US FDA Registered · ISO 13485 Certified · CE Marked · CDSCO A–D Licensed
Cleanrooms
9 manufacturing + 2 testing, 7,760 sq ft ISO 7
Sterilisation
2 ETO machines, ISO 11135 validated, 588 CF
Packaging
14 sealing machines — Tyvek, paper pouch, blister
Products made
Coronary stents, PTCA balloons, catheters, valves

Distribution & sales

A vast network of commercial channel partners, experienced sales professionals, and deep KOL relationships across every major geography.

Indian Distribution Network
Mumbai Delhi NCR Bengaluru Chennai Hyderabad Pune Kolkata Cochin
Key Markets
India
The fastest-growing major economy in the world
South Africa
Africa's most industrialised economy, and gateway to Sub-Saharan Africa
Saudi Arabia
The Middle East's largest economy, investing $65B+ in healthcare under Vision 2030
UAE
The Middle East's healthcare & logistics hub, bridging global markets
Therapy coverage
Cardiac & Interventional Cardiology Robotic & MIS Ortho, Spine & Neuro Diagnostics & Vascular
Innovations We Champion

Breakthrough MedTech innovations, brought to market with Indical

Indical backs the world's most inventive medical technologies and carries them through to commercial success — across CRO, regulatory, manufacturing, and distribution. Company names are withheld at our partners' request; the innovations speak for themselves.

Heart Valves

Cardiac Surgery · Structural Heart
Regulatory · India Entity · Clinical Trial · Commercial

Microbubble Kidney Stone Therapy

Urology · Stone Management
Regulatory · India Entity

Robotic Dental Surgery System

Dental Surgery · Robotics
Regulatory · Clinical Trial · Commercial Launch

Robotic Surgical System

General Surgery · Robotics
First-in-Human · Regulatory · India & Middle East entities · Commercial

4K ICG Visualisation System

Surgical Imaging · Fluorescence
Regulatory · Clinical Evaluation · Commercial Launch · Distribution

Panoramic Endoscopic Visualisation

Endoscopy · Surgical Imaging
Regulatory · Distribution
Success Story

Robotic Surgical System · First-in-Human in India

1st
First-in-Human robotic surgery in India
Indian Entity
Legal entity established by Indical
AMEA
Full commercial launch across the region
Challenge

A UK-based surgical robotics innovator needed a trusted India partner to navigate CDSCO approvals, establish a local entity, conduct India's first-in-human robotic surgery evaluation, and activate a commercial pathway across the AMEA region — within an aggressive timeline.

Indical's Role

Served as Authorised Indian Representative, managed all CDSCO regulatory submissions, established the company's Indian legal entity, coordinated the first-in-human evaluation across top surgical centres, and activated the AMEA commercial distribution channel.

Our Leadership Team

Global MedTech expertise, deep India knowledge

BS41 yrs
Brad Sharp

Brad Sharp

Founding Partner

View bio

Brad Sharp

Founding Partner · 41 yrs

A technology and medical-device leader with 41 years in high tech — the last 25 as a medical-device CEO — with a track record of taking businesses from inception to full global launch.

He ran cardiology for Baxter CVG in Japan and led all of Asia for Edwards Lifesciences, and has brought two startups from inception to worldwide commercialization.

Brad holds a degree in applied physics and speaks Spanish, Korean, and Japanese. As Founding Partner of Partisan, he anchors Indical’s global network and strategic direction. Based in Irvine, CA.

LK40+ yrs
Laxmikant Khanolkar

Laxmikant Khanolkar

Managing Director

View bio

Laxmikant Khanolkar

Managing Director · 40+ yrs

A global healthcare leader with more than four decades shaping the pharmaceutical and medical device industry — building markets, scaling breakthrough technologies, and turning strategic vision into commercial reality.

He has held senior roles at Edwards Lifesciences, Baxter Healthcare, and Glaxo. As COO of Insightra, he led development, commercialization, and distribution of cardiovascular products.

Most recently, as Asia Pacific Head at CMR Surgical, he spearheaded regional expansion and scaled robotic-assisted surgical technology across key markets — navigating regulation and forging the partnerships that powered APAC growth.

SR40 yrs
Sanjay Rane

Sanjay Rane

Head of Operations

View bio

Sanjay Rane

Head of Operations · 40 yrs

A seasoned operations leader with 40 years across the hospitality and medical device industries — a background that sharpened a rare instinct for running complex, service-critical operations with precision.

He specializes in strategic management, process optimization, and team leadership, with a proven record of overseeing intricate operations end to end and embedding the best practices that drive efficiency.

Anchored by a commitment to excellence and continuous improvement, Sanjay builds high-performing teams and delivers the operational discipline that turns strategy into consistent, on-the-ground results.

MJ15+ yrs
Dr. Manisha Jadhav

Dr. Manisha Jadhav

Head of Clinical Affairs

View bio

Dr. Manisha Jadhav

Head of Clinical Affairs · 15+ yrs

An accomplished healthcare professional with 15+ years across clinical research, professional education, medical affairs, and hospital administration — with senior roles at Integrated Endoscopy (Global VP), Foldax Inc (India Clinical Manager), and CMR Surgical.

Across India, the Middle East, and Africa she has built service and support teams, developed training pathways, and led market-entry strategies. An adept clinical-trials strategist, she has managed global studies across cardiothoracic, general surgery, gynecology, and oncology.

Her impact extends into hospital administration — implementing NABH protocols and directing operations. As a thought leader she has authored scientific manuscripts and collaborates with global key opinion leaders to advance medical research.

SB22+ yrs
Shruti Bhat

Shruti Bhat

Head of Regulatory & Quality

View bio

Shruti Bhat

Head of Regulatory & Quality · 22+ yrs

A regulatory and quality expert with 22+ years spanning multinational corporations, start-ups, and academia across pharma and medical devices — equally effective at building systems from the ground up and scaling them to global standards.

She specializes in regulatory affairs, quality assurance, and manufacturing, ensuring compliance with global requirements, leading robust quality management systems, and overseeing manufacturing operations end to end.

Shruti holds a Master’s in Pharmaceutical Sciences and Technology with a specialization in Quality Assurance — pairing deep technical expertise with the rigor behind safe, compliant, market-ready products.

AP15+ yrs
Abhishek S. Padmanabhan

Abhishek S. Padmanabhan

Head of Finance

View bio

Abhishek S. Padmanabhan

Head of Finance · 15+ yrs

A finance leader with over 15 years in accounting, financial management, and administration, built across multinational medical device companies including Insightra Medical and CMR Surgical.

He specializes in financial analysis, modeling, budgeting, and forecasting — translating numbers into strategic insight, alongside a proven record of streamlining processes, optimizing costs, and ensuring compliance.

Abhishek holds a Bachelor of Commerce (Accountancy) and an MBA in Corporate Finance, pairing deep technical grounding with a strategic view of how finance powers a growing enterprise.

The Partnership Journey

From first conversation to commercial success

Week 1

Discovery Call

We understand your product, therapy area, and commercial goals for India.

Weeks 2–3

Strategy & Pathway

Tailored India entry strategy: regulatory, clinical plan, distribution model.

Week 4

NDA & Agreement

NDA and service agreement executed. Scope, timelines and terms agreed.

Months 2–4

Regulatory Submission

Indical files the application to CDSCO.

As applicable

Clinical Execution

If required, Indical's CRO runs India clinical evaluations or registry studies.

Months 10–18

Commercial Launch

Product approved. Distribution activated. First sales and ongoing support.

Let's Build Your India Story

India's single-window MedTech partner, since 2012

India HQ

Indical MedSurg Pvt Ltd

A/4, Ground Floor, Vile Parle Colony CHSL
Sahakar Road, Vile Parle (East)
Mumbai – 400057, India

T: +91 9623243509
E: manisha@indicalmed.com
Dr. Manisha Jadhav
VP, Clinical Affairs
Global Headquarters

Partisan Healthcare Advisory LLC

8 Japonica
Irvine, CA 92618
USA

T: +1-949-892-7812
E: brad@partisanmed.com
Brad Sharp
Founding Partner, USA