MedTech Product Cycle
Neuromodulation is a stimulation of the nerve at specific locations in the nervous system. Depending on the stimulation site + other factors, the benefits can be pain relief, control of tremors for Parkinson's Disease patients, among other benefits.
Pacemakers is a device that uses electrical stimulation to prompt the heart to beat at normal rates/control abnormal heart rhythms.
Left ventricular assist devices (LVAD) are electromechanical pumps for assisting with cardiac circulation - which is used to either partially or to completely replace the function of a failing heart.
Improving Patient's Quality of Life
Deteriorated physical and mental health impacts a patient's ability to live and thrive in their environment. The patient can only focus on surviving. When a medical device successfully meets its user's needs, it offers patients and their loved ones an improved quality of life, because it reduces deteriorated health as an obstacle to living.
Experience in the MedTech Space
I have worked primarily on Class III devices - pacemakers, heart pumps, neuromodulation (spinal chord stimulation and deep brain stimulation) products, and their associated system devices and accessories.
Over the past 5 years in the medical device industry, I have worked on cardiac and neuroscience products as a quality engineer. My experience includes working in roles from mechanical development quality through manufacturing quality and supplier management. These roles have allowed me to be a part of the full-life cycle and operation aspects of the medical device business, including bringing a medical device to commercialization. During my time in the medical device industry, I have earned a Black Belt Six Sigma Certification, a SolidWorks Mechanical Design certification as well as been certified as a Quality System Lead Auditor. Prior to full-time experience, I received a bachelor's degree in Biomedical Engineering from Georgia Tech, where I interned at a start up incubator, performed wet-lab research on cancer drug therapeutics, and interned as a designer for cardiac devices.
Most recently, I begin consulting with entrepreneurs to develop devices for the pediatric population. Reach out if you are seeking for a consultant in medical device mechanical development through manufacturing and product launch.
Medical Device Design Life Cycle and Commercialization Summary
In order to enter the market, a medical device must be approved by regulatory bodies and meet standards and regulations set by its class. A medical device is classified based on risk to the patient and there are three classes of products:
1. Class I - Minimal potential for harm to the user. Example: bandages
2. Class II - Moderate risk of harm to the user. Examples: catheter and blood pressure cuffs
3. Class III - High risk of harm to the user which includes devices that sustain or support a user's life. Examples: pacemakers and neurostimulators.
During the product development cycle, medical devices go through the 'design control process' in order to commercialize the product. The intent of the design control process is to create safe medical devices that meet the user needs and product specifications (i.e. ensure that the product does what we say it does). Learn more about the medical device design control process, the product development process, and the FDA waterfall.