Max Neeman International is India’s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies. The portfolio of the services include comprehensive Phase II-III clinical trials, regulatory submissions, phase IV post approval programs & commercialization services.

1. Device
Exper+se
Dr. Jayashri Krishnan
Senior
Manager,
Clinical
Opera1ons

2. 2
Dr. Jayashri Krishnan
Senior Manager, Clinical Operations
Experience
Dr. Jayashri Krishnan is a leading clinical research professional who is highly motivated and
creative with more than 17 years of Academic and Industrial Clinical Research experience;
specialized in Medical Devices, Dermatology and Ophthalmology. Her experience includes
conducting and executing global medical research through strategic planning, management and
driving her team with timely deliverables to the clients. She has excellent organizational skills,
communication with clients, and customer focus with a high level of attention to detail. Dr.
Jayashri proactively identifies and for sees operational risks in clinical trials from study start, and
then develops project specific risk mitigation plans accordingly. She has been very resourceful
and has mentored many employees through her training skills to ensure compliance with ICH –
GCP Guidelines and applicable national and international regulations.
Role
At Max Neeman, Dr. Jayashri has grown with Clinical Operations and been a pioneer in developing
the Standard Operating Procedures and Implementation strategy. She has wide therapeutic area
knowledge as a Medical Device expert and has worked across all phases of clinical trials with
strong project management and business management skills. Through her excellent project
execution and auditable regulatory data, many of the Medical devices have been CE-marked for
European marketing authorization. She is passionate about Clinical Research and holds a Medical
& Doctorate degree to her credits.
Client’s Trust
She has always been an asset to the Max Neeman organization and gains repeat business from
her customers thus receiving awards and recognition within the organization and also from
Clinical Research bodies for her excellence in Clinical Research.

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Medical Device Market in India
q India’s medical device market is currently the fourth largest market in Asia
with 700 medical device makers, and ranks among the top 20 in the world*
q Valued at $ 4.4 billion in 2013, the Indian medical device and equipment market grew to
around $ 5.8 billion by 2014 and is expected to reach to $ 7.8 billion by 2016, growing at a
CAGR of 15.5 per cent,
q Today, India’s medical device sector is dominated by multi-national companies, which is
evident from the fact that about 75% of the sales are generated by imported medical devices.
But Indian government approved 100% FDI in medical devices via the automatic route, on
25th Dec, 2014. A foreign investor will no longer have to go to the Foreign Investment
Promotion Board (FIPB) for permissions - they had to till now, which was a time-taking affair
q A significant percentage of purchasers of medical devices are private medical institutions and
hospitals, which used to be importing everything from disposable plastic and wound care
products to precision metal implants
*India Semiconductors Association
**Indian Medical Technology Sector, Grant Thornton

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Regulatory Framework for
Medical Devices
q There are certain medical devices which have been regulated by
creating a statutory fiction thus deeming these medical devices as
“drugs”. By virtue of this, these few medical devices get regulated by the
Drugs and Cosmetics Act, 1940 and the rules framed there under viz.
Drugs and Cosmetics Rules, 1945. They are referred to as “Notified
Medical Devices”
q The regulation of Notified Medical Devices is overseen by both, the
central government and the state governments
q In specific instances such as manufacture or import of new Notified
Medical Devices, both a permission from the central drug licensing
authority and a license from the state drug licensing authority is required

5. 5
The following categories of medical devices were notified by the Ministry of Health
and Family Welfare through Gazette notification:
• Disposable Hypodermic Syringes
• Disposable Hypodermic Needles
• Disposable Perfusion Sets
• In Vitro Diagnostic Devices for HIV, HBsAg and HCV
• Cardiac Stents
• Drug Eluting Stents
• Catheters
• Intra Ocular Lenses
• I. V. Cannulae
• Bone Cements
• Heart Valves
• Scalp Vein Set
• Orthopedic Implants
• Internal Prostatic Replacements
Through the DCGI Office order, it is clarified that any devices other than above do not require
any registration, license, permission or NOC for their import or manufacture, sale and
distribution so far as the provisions of Drugs and Cosmetics Act and Rules made there under are
concerned.
Regulatory Framework for
Medical Devices

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Experience in Medical Devices
Max Neeman has conducted more than 25 medical device studies till date in
all clinical phases of development, with experience ranging from single
center studies to large multi-country trials. Our experience spans across the
spectrum of indications to include: Cardiology, Ophthalmology, Neurology &
Gastroenterology.
Study Phase
Congestive Heart Failure – Acute Pre-Market
Atherectomy with Stent Pre-Market
Congestive Heart Failure Pre-Market
Congestive Heart Failure – Extension Pre-Market
Coronary drug eluting stent in patients with de novo lesion Pre-Market
Drug-Eluting Stent to Treat CAD Pre-Market
Heart Failure Pre-Market
Drug Eluting stent Pre-Market
Guidewire in total occlusion of coronary arteries Pre-Market
Drug Eluting stent Pre-Market

7. 7
Study Phase Sites Subjects
Cardiology
Congestive Heart Failure – Acute Pilot 1 40
Atherectomy with Stent Pilot 4 50
Evaluation of drug eluting stent in patient
population
IV 50 1830
Congestive Heart Failure III 8 180
Congestive Heart Failure – Extension 6 40
Coronary drug eluting stent in patients
with de novo lesion
III 5 120
Drug Eluting Stents in Clinical Practice IV 25 1000
Coronary stent in routine practice IV 12 400
Drug-Eluting Stent to Treat CAD III 8 350
Sample List of Device Studies (1/3)

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Study Phase Sites Subjects
Cardiology cont’d
Intravenous UFH during PCI in high risk
patients with UA/NSTEMI
IV 5 100
Heart Failure Pilot 3 96
Atrial Fibrillation IV 60 800
Drug Eluting stent IV 9 180
Drug Eluting stent III 6 40
Cardiac Pacemaker IV 14 670
Guidewire in total occlusion of coronary
arteries
Pilot 1 20
Sample List of Device Studies (2/3)

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Study Phase Sites Subjects
Ophthalmology
Post Uveitis III 1 120
Non-Infectious Anterior Segment Uveitis I/II 6 35
Punctal Plug Use III 1 110
Contact Lens 2 80
Neurology & Spinal
Gait Disorder Pilot 1 15
Stroke III 4 100
Spinal Stenosis Pilot 4 40
GI & Urology
Linear Stapler III 3 300
Prostate Surgery Pilot 1 30
Sample List of Device Studies (3/3)

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Case Study-1
q Study Title: A Prospective, Single Blind, Multi-center, Randomized Trial to
Compare the XXX Coronary Stent System against the XIENCE Prime™
Coronary Stent System in the treatment of a Diabetic Patient Population in
India
q Study Design: Prospective, multi-center, single-blind, randomized clinical trial
q Enrollment Target: 1830
q No. of Sites: 46
q Status: Completed
q Highlights: Max Neeman has ensured steady recruitment at the sites for the
study maintaining high quality documentation even in the presence of
competitive trials & have addressed the medical/ safety related queries of the
investigators in a timely manner thereby keeping the sites engaged in the
study.

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Case Study-2
q Study Title: Biorobotic Aquablation Pilot Study (APS) for the treatment of
Benign Prostatic Hyperplasia
q Study Design: Prospective, single-center, open label clinical trial
q Enrollment Target: 30
q No. of Site: 1
q Primary Objective: The objective of this study is to establish safety
(freedom of adverse events) and effectiveness (improvement in baseline
IPSS score) of the PAS
q Status: Follow up ongoing
q Highlights: Max Neeman has ensured recruitment of all patients within 1
week through extensive screening and ensuring completion of surgery
with the supervision of sponsor and MNI’s biomedical team

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Case Study-3
q Study Title: Randomized, Prospective Study of the Effectiveness,
Safety, and Clinical Outcomes of Stapled in Patients Undergoing
Gastrointestinal End to End or Side to Side Anastomoses.
q Study Design: Prospective, multi-center, open label randomized clinical
trial
q Enrollment Target: 280
q No. of Site: 3
q Study overview: The study was done to determine the effectiveness,
Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-
Sutured Anastomoses
q Status: Completed

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Case Study-4
q Study Title: Autonomic Neurostimulation Therapy to Enhance
Myocardial Function in Heart Failure Study
q Study Design: Prospective, multi-center, open label clinical trial
q Enrollment Target: 60
q No. of Site: 12
q Study overview: Patients with symptomatic heart failure were
treated with Intermittent therapeutic vagus nerve stimulation. The
device being studied includes the Implantable Pulse Generator
(Model 103) which is implanted in pectoral region and a VNS
Therapy lead (Model 304) which is attached to the cervical vagus
nerve.
q Status: Patient Follow up

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To Learn More
Contact Information:
Ann Vawter
Director, Business Development and Marketing
E: ann.vawter@neeman-medical.com
www.neeman-medical.com