Device Expertise

Device Exper+se Dr. Jayashri Krishnan

Senior Manager, Clinical Opera1ons

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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

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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

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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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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


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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


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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  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  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  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: [email protected] www.neeman-medical.com

Device Expertise

Health & Medicine

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