[vc_row][vc_column width=”1/2″][vc_single_image image=”1278″ title=”Srikanth Majji — DoseOptics, LLC – Product Manager” label=””][/vc_column][vc_column width=”1/2″][vc_column_text]

  1. AREAS OF EXPERTISE

My academic proficiency is in Mechanical Engineering with a specialization in Design and Development of Medical Devices. In this broad-spectrum field, my predominant focus is on New product development, New Product Introduction, Medical device design, R&D, Production/ Manufacturing technology, Prototype development and testing, Additive manufacturing, Capital Equipment sourcing, Vendor Management, Material sourcing, Supplier Qualification, Verification and Validation. My top skills include Mechanical Design, Additive Manufacturing, Medical device development, Project planning. 

 

Summary of Professional and Research expertise 

In my 8+ years of industrial experience, I predominantly worked towards the design and development of Class II and Class III medical devices. I held positions from entry level internships to my current crucial role, Product Manager at DoseOptics, LLC. I graduated in Mechanical Engineering with design Specialization at Koneru Lakshmiah University which ranks #152 position among 876 universities in India. The flexible curriculum at the university gave me better opportunity to explore more and become proficient in the field of Mechatronics, Computer Integrated Manufacturing (CIM), Nanotechnology, Mechatronics, Micro-Electromechanical Systems (MEMS) etc. 

Additionally, with thousands of participants, I was awarded 1st place in a highly competitive event, Nation-wide competition, Dual Mode Vehicle Challenge held at APOGEE 2012, conducted by BITS Pilani, Pilani Campus, India sponsored by ASME. Being the only vehicle among the participants that completed full length challenge track without any extrinsic support from pilot and co-pilots and being the lowest cost and most durable design among the participants. In a second considerable accomplishment, I was in top 3 in a competition – Project X, conducted at IIT Madras National Fest. I am prouder of this accomplishment as it was an ‘on the spot’ design’ event in which a boat is to be made and winners are decided according to the time taken for its completion. 

A supplement to my educational career was a close acquaintance with real time industrial workspace through a program designed at our university called “Practice School Program”. I led a team of 5 members for the project, “Manufacturing of gearbox thrust cum journal bearing by using reverse engineering and rebabbiting process”, at Turbo Engineering Services, India. By working in Engineering, Quality and Inspection departments, I attained the knowledge on manufacturing of bearings, Non- Destructive Testing (NDT) tests conducted, Reverse Engineering and Rebabbiting techniques. This enriched my leadership qualities and teamwork ethics as a complement to my energies I contributed for the successful completion of the project. 

The third and crucial episode that led to a lifetime resolution started when I was one among the three, out of 300, that got selected for Amara Raja Group of companies in campus placement. The experience in this organization led me to learn about the Industrial Automation applications such as Welding robots, semi-automated roll forming machines and Conveyor systems that are available at the plant location. This helped in expanding my sphere of knowledge in the field but also on the Operational Intelligence aspects in the workflow of a Manufacturing firm. This made me a model and simulation expert for my future projects. 

 

I worked as an intern at iLensys Technologies Private Limited, Jubilee hills, Hyderabad, which is a R&D CAD service provider for Thermofisher Scientific, USA. Thermofisher Scientific is a global pioneer in medical devices. I used my expertise of operational intelligence for the project “SolidWorks Enterprise Product Data Management (EPDM) Data Migration”. I designed an optimal workflow for the documents and provided precise user permissions to maintain the confidentiality as-is and improvise user access. I contributed to automation testing for software tools used in the project to find bugs and monitored complete metadata of project files. I was awarded with an internal organizational honor for successful completion of the project prior to agreed deadline. I was absorbed in the organization itself after my internship period in the position of Associate Consultant (CAD Design Engineer). The second project worked on is a New Product Development (NPD) Project where I gained expertise with constraints to be considered in evolving a new product which reinforced me to understand the current breakthroughs in the field of medicine and medical devices such as Exoskeletons, Brain Computer Interfaces (BCI), Targeted Drug Delivery Methods, etc. I contributed to designing concepts by creating 3D CAD models and Drawings. I designed 3D printed parts which are involved in our design various methods and applications emerging in the market. As a result, I gained expertise in 3D Printing technologies and awarded with another Organization honor. 

I received more than $13,000 (10,00,000 INR) of Grant in aid from the State Government (Andhra Pradesh, India) for my outstanding accomplishments to pursue my higher studies. Every year only top 0.1% of the students in our state will be awarded with this scholarship. 

 

Experience and Projects: 

Product manager JD for the ad to my position: 

DoseOptics is a Dartmouth spin-off company that has developed the world’s first camera system, BeamSite™, capable of imaging radiation therapy treatments directly on patients. With recent FDA 510k-clearance, we are in the early stages of commercialization and poised for rapid growth. Our core team is made from world class scientists, engineers and clinicians working together to develop novel imaging technologies with a goal to improve radiotherapy treatments leading to improved outcomes and saving lives. As a Product Manager, I joined the team to drive and manage product development, manufacturing and early-stage commercialization activities. Ideally, we are looking for someone who can “do and direct” at the intersection of development and manufacturing in a post-market operational setting. 

Responsibilities: 

 

Monitor Health LLC: Mechatronics Engineer 

Projects: 

MH ECG Sensor Patch: 

Global ECG Market was valued at $4,516 million in 2016, and is expected to reach $6,637 million by 2023, registering a CAGR of 5.6% from 2017 to 2023. Electrocardiograph (ECG) is a non-invasive medical test that records the electrical activity of the heartbeat over a period of time. ECG monitoring devices such as, resting ECG, stress ECG, and Holter monitors help identify and provide information about abnormal functioning of the heart. Cardiovascular disease is one of the most common health problems faced by people across the globe, with high mortality rate accounting for approximately 370,000 people deaths annually in the U.S. alone. This propels the demand for ECG market as the increase in number of ECG tests are conducted by people, susceptible to heart diseases. The other key factors that boost the growth of electrocardiograph (ECG) market include technological advancements in ECG devices such as portable and handheld, rise in incidence of cardiovascular diseases globally, increase in geriatric population, and favorable government regulations regarding monitoring devices. 

 

The novelty of our device originates with the communication protocol followed for data transmission to MQTT server and the 24 x 7 live data analytics that we offer with the device to the end user as well as the doctor. The current competitor devices in the market are including an additional device for data transmission and communication with the server. This results in additional plastic parts and electronic boards, chips that eventually end up in the landfills if not recycled properly. Considering the US and global trends for recycling the used products, we eliminated this issue by adding a RF antenna and communication module embedded on the sensor device. This also allows us to reduce the carbon footprint in a larger scale compared to our competitors. Our competitors are providing the end users with a processed data after the devices are returned to the OEM facility. This current approach followed in the market has the risks of delay in the diagnosis leading to patient critical conditions. Based on our experience from the numerous data that we acquired over the period of 6-8 years in this market space with our existing device, it is evident that there are some events that are not being properly diagnosed during the Holter monitoring. We are handling this by providing the user with an option to record the symptoms with a simple push button and send us a voice input via microphone embedded in the device. This will be sent to the server with a timestamp attached to the data which will be displayed in the text format on the server and his reports for a detailed diagnosis for the technician as well as the doctor. 

 

Roles and Responsibilities include: 

 

Artificial Pancreas Project (APP): 

The Artificial Pancreas Device System is a system of devices that closely mimics the glucose regulating function of a healthy pancreas. Most Artificial Pancreas Device Systems consists of three types of devices already familiar to many people with diabetes: a continuous glucose monitoring system (CGM) and an insulin infusion pump. A blood glucose device (such as a glucose meter) is used to calibrate the CGM. A computer-controlled algorithm connects the CGM and insulin infusion pump to allow continuous communication between the two devices. This System will not only monitor glucose levels in the body but also automatically adjusts the delivery of insulin to reduce high blood glucose levels (hyperglycemia) and minimize the incidence of low blood glucose (hypoglycemia) with little or no input from the patient. 

The FDA is collaborating with diabetes patient groups, diabetes care providers, medical device manufactures, researchers, and academic investigators to foster innovation by clarifying agency expectations for clinical studies and product approvals. These efforts have accelerated the development of the first hybrid closed loop system, the Medtronic’s MiniMed 670G SystemExternal. 

Diabetes is a group of diseases characterized by high blood sugar. When a person has diabetes, the body either does not make enough insulin (type 1) or is unable to properly use insulin (type 2). When the body does not have enough insulin or cannot use it properly, blood sugar (glucose) builds up in the blood. Prediabetes is a condition in which blood sugar is higher than normal but not high enough to be classified as diabetes. People with diabetes can develop high blood pressure, high cholesterol, and high triglycerides (a type of fat in the blood). High blood sugar, particularly when combined with high blood pressure and high triglycerides, can lead to heart disease, stroke, blindness, kidney failure, amputations of the legs and feet, and even early death. 

Number and percentage of the U.S. population with diagnosed diabetes were obtained from the National Health Interview Survey (NHIS, available at http://www.cdc.gov/nchs/nhis.htm) of the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Conducted continuously since 1957, the NHIS is a health survey of the civilian, noninstitutionalized population of the United States. The survey provides information on the health of the United States population, including information on the prevalence and incidence of disease, the extent of disability, and the use of health care services. Estimates for years 1958–1979 were obtained from published data,5 and estimates from 1980 forward were derived directly from the NHIS survey data. Because diabetes questions were not included in the survey for some years before 1980, the estimates were missing for these years. 

Diabetes is also associated with increased risk of certain types of cancer, such as liver, pancreas, uterine, colon, breast, and bladder cancer. High blood sugar also increases a person’s chance of developing dementia and Alzheimer’s disease. In addition, the average medical costs for people with diagnosed diabetes are 2.3 times higher than costs for people without diabetes. These higher costs are often caused by diabetes-related health conditions and resulting hospitalizations. 

The Diabetes Report Card provides current information on the status of diabetes and its complications in the United States. It has been published every 2 years since 2012 by the Centers for Disease Control and Prevention (CDC). 

This publication includes information and data on diabetes, preventive care practices, health outcomes, and risk factors such as race, ethnicity, level of education, and prediabetes. It also includes information about national trends and, to the extent possible, progress made by the states to meet national goals for improving diabetes care and reducing health care costs and the rate of new cases. 

For people with diabetes, research shows that: 

Key Market Insights: 

The non-invasive glucose monitor market will create at a CAGR assessment of 10.5% from 2020 to 2026. The measuring devices will produce the most noteworthy income and have the biggest offer in the market. The Asia Pacific will grow faster than North America in terms of CAGR%, attributable to rising inclination and requirement for effortless far-off patient observing. 

Major companies in the market are Google, Abbott Diabetes Care, Medtronic, Apple, Alertgy, Integrity Applications, Senseonics, NovioSense BV, GENEXO, Nemaura Medical, Ambrosia Systems Inc., Glucology, Sano Intelligence, Biolinq, Echo Therapeutics, Siren, GraphWear, Socrates Health Solutions, FeetMe, Dexcom, Insulet Corporation, Diabeloop, mySugr, One Drop and EasyGlucose among others. 

The global artificial pancreas device system (APDS) market size was valued at US$ 123.5 Mn in 2018, and is expected to witness a CAGR of 14.1% during the forecast period (2020 – 2027). 

The novelty of our device originates with the non – invasive technique that we are developing to reduce the pain of the end users, communication protocol followed for data transmission to MQTT server and the 24 x 7 live data analytics that we offer with the device to the end user as well as the doctor. The current competitor devices in the market are including an additional device for data transmission and communication with the server. This results in additional plastic parts and electronic boards, chips that eventually end up in the landfills if not recycled properly. Considering the US and global trends for recycling the used products, we eliminated this issue by adding a RF antenna and communication module embedded on the sensor device. This also allows us to reduce the carbon footprint in a larger scale compared to our competitors. Our competitors are providing the end users with a processed data after the devices are returned to the OEM facility. This current approach followed in the market has the risks of delay in the diagnosis leading to patient critical conditions. 

 

My value addition for this Artificial Pancreas Project includes: 

For Continuous Glucose Monitoring System: 

For stand-alone Insulin Pump System: 

 

Benevolance / Life Saver Syringes: 

“WHO has a mandate, to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization”. 

Conventional syringes can be reused several times and they are the main cause of needle stick injuries, leading to blood borne infections among patients and healthcare workers. Re-use of injection equipment is also responsible for most of the infections that result from immunization. A 2014 World Health Organization (WHO) study estimates: up to 1.7 million people were infected with Hepatitis B virus due to unsafe injections. More than 16 billion syringes are used worldwide every year with expenditure of USD 535 million The majority of injections are made with conventional syringes that place expose patients at risk of disability and death. In developing countries injection devices are reused without sterilization. 1.3 million early deaths from unsafe injection practices 38,000 with HIV Up to 315,000 with Hepatitis C Unsafe practices include, but are not limited to, the following prevalent and high-risk practices: Reused injection equipment (40% of the 16 billion) Accidental needle-stick injuries (NSIs) in health-care workers Unsafe sharps waste management. We will be designing and manufacturing the self-injury prevention syringes to avoid these syringe related infections and deaths. 

 

My contributions for this project include: 

Steam and Process Repairs, Gonzales, Louisiana: Mechanical design Engineer 

 

Steam & Process Repairs offers cost-effective solutions and responsive field engineer support for all the piping system repair needs. It also offers experienced and diligent staff have the equipment and the knowledge to ensure the efficient, on-site repair of virtually any type of leak you may have. The solutions in S&P Repairs is mainly aimed at saving huge chunks of amount and resource manpower involved in the costly shutdowns of the plants. They provide a large range of repair services, including leak sealing, pipeline system rehab, hot tapping and line stops, concrete repairs and technical bolting. S&P also maintains a full-service fabrication shop for the production of fittings, high-pressure repair clamps, and leak sealing enclosures. Steam & Process is available on-call 24 hours a day, 365 days a year. 

 

A few of S&PR notable clients are: 

 

Steam and process mainly offers Leak sealing, Hot Tap solutions, Line Freeze solutions. 

Leak Sealing: Steam and process offers leak sealing solutions for industries Steam which are non-destructive leak sealing services for high pressures and temperatures and varied processes. 

Hot Tap Division: Hot tapping allows the safe and controlled entry into pipes, tanks, or vessels under pressure without interrupting system function and without any loss of product. 

Line Freezing: This safely isolates a piping system to allow maintenance or repairs without a shutdown. 

When an industrial equipment is leaking, it has several options of mitigating the leak. It can isolate the equipment and make the repairs. It can bypass the line, using an alternate system or backup system and make repairs to it. A temporary leak sealing device can be fabricated and installed around the leak area, that is tested for the maximum pressure and temperature and is compatible with the equipment material and the process of that equipment. An industry generally performs scheduled maintenance annually. Their maintenance engineers continuously monitor the equipment for any abnormalities such as pressure drops, temperature fluctuations, volume changes etc., that let them know if something is wrong with the equipment. A probable cause might be due to the leakage in the equipment. A leakage can be fatal to the personnel / other equipment near it because of the toxicity or temperature or the pressure or the corrosivity of the process or the service in it which needs to be addressed immediately. One way of dealing with it shutting down the equipment and repairing it ASAP. But that is not feasible all the time as shutting down certain equipment may cause the entire unit to shutdown which halts the production which in turn may result in losses. For example, a leak in the power industries such a cooling tower water or boiler feed water may cause the temporary shutdown of boilers or turbines which may in turn stop the power supply. That’s where the temporary leak sealing devices come in play as they go around the leaking area containing the leak and strong enough to withstand the process pressure and temperature. 

Whenever there is a leak and the plant want to continue with their operations without shutting 

it down they would generally consider a leak repair, that would be ranging from a simple wrap 

using machine grade wraps engineered to withstand small leaks, corrosions etc., to a leak sealing 

device such as clamps and enclosures. 

For devising a leak sealing enclosure, the field technicians from steam and process visit the 

plant, identify the leak area and discuss with the engineers to devise an optimal leak sealing 

route. They take the measurements around the leak area for the whole equipment and send it 

to the engineers. The engineers procure all the data related to that equipment such as the 

process (Chemical Composition), max pressure and temperature, material. They also gather the 

equipment condition and all the mechanical data such as the presence of wear and corrosion, thickness readings etc. once all the data is received, the engineers enter the crude drawings and 

measurements pertaining to the equipment provided by the field technicians into the software. 

The engineers develop the 3D and 2D models from the crude drawings. The engineers refer to 

all the drawings for any obstructions and design an enclosure that doesn’t hit the obstructions. 

and can be installed in the field and they also design in accordance with ASME Code 8, Div 1. 

Also, the engineers consider the aspects of DFM while designing to ensure the fabrication 

feasibility in the machine shop. 

I am responsible for all the inventory maintenance and forecasting, vendors and supplier interactions for the raw material sourcing such as pipes, plates, Tubing, bars (round and rectangular), studs and nuts that would be used in the enclosure fabrication and assembly. I have to take care of the logistics planning, prefabrication and post fabrication NDE’s such as lamination scan, PT Root & Cap, UT readings, etc. 

 

 

 

 

Ilensys Technologies Private Limited (ThermoFisher Scientific): 

 

Associate Consultant (R&D CAD): 

 

EPDM Implementation: The aim of this project is to upgrade the existing workflow and implement a better workflow with better security with respect to the user access and control. 

 

 

E-Warrior: 

REVA: 

 

 

Work summary & Responsibilities: 

 

 

  1. Mangal Industries Limited:

I started my career at Silver Lining Storage Solutions, a sister concern for Mangal Industries limited, India. This was a campus placement attended by almost 1100 student peers who were scrutinized through several layers in the recruitment process. I was one amongst the 3 candidates that cracked through all the layers and ended up with the job placement. I was offered a role of the Production Planning and Control Engineer. This is a new establishment and new market space for the Parent Company Mangal Industries Limited. Silver Lining Storage solutions 

My key responsibilities include: 

 

 

 

 

 

 

 

 

 

 

 

  1. CATEGORIES OF EVIDENCE

 

Honors & Awards 

 

NTR Videshi Vidhyadharana: I received more than $13,000 (10,00,000 INR) of Grant in aid from the State Government (Andhra Pradesh, India) for my outstanding accomplishments to pursue my higher studies. Every year only top 0.1% of the students in our state will be awarded with this scholarship. 

 

Organizational Honors 

Monitor Health LLC: 

iLensys Technologies Private Limited: 

 

Student Awards: 

o My vehicle is the most economical in the event with production costs less than 35$ (2000 INR). 

o I built the vehicle which is the only one to complete all the tasks in the shortest time possible in the event. 

o My vehicle is the only one to have a smooth transition from water to land without any human intervention to push it across the border. 

 

 

Distinguished offers from high-ranking schools 

 

Certifications: 

Certified Solid Works Professional – Mechanical Design 

Certified Solid Works Associate – Additive Manufacturing 

 

Leading & Critical Roles 

 

Monitor Health LLC: 

 

I play a pivotal role in the organizational structure for the implementation of the ideas into projects for the currently on going in Monitor Health LLC as follows: 

 

 

Research and Mentorship Responsibilities 

 

iLensys Technologies Private Limited: 

 

 

 

Administrative Responsibilities 

 

I was the admin for Solid Works EPDM after its successful implementation 

 

Judge the Work of Others 

 

 

Evaluating others in performance of work 

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