Joel Phillips Email & Phone Number

Minneapolis, MN, US

Maple Grove, Minnesota, US

• Francis Medical is a clinical-stage start-up medical device company developing sterile water vapor ablation technology for treating prostate cancer. The product is a software controlled electro-mechanical device with.
• QMS Management Representative reporting to CEO; Executive Management team member focused on company, regulatory, and QMS strategy;
• Primary focus on FDA engagement in a series of FDA pre-submission meetings around technology mechanism of action, early clinical results, and proposal for pivotal trial for prostate tissue ablation and cancer.
• Design Verification complete on first iteration of prostate cancer vapor ablation device;
• FDA Investigational Device Exemption approval for Early Feasibility Study in U.S. and completion of EFS with excellent early results;
• Next generation product development focused on improved product quality, manufacturability, and performance;

Plymouth, Minnesota, US

• Incisive Surgical designs, develops, and manufactures implantable Wound Closure devices (EU Class III, US Class II) using molded biodegradable polymer staples and associated delivery systems.
• Over 2 million devices sold;
• 75 million biodegradable staples produced;
• “Clean” QMS: no FDA 483’s, no Major Nonconformities;
• Less than 0.031% Complaint rate;
• 84% reduction in complaint rate by design changes;

• Anulex designed, developed, and manufactured Spinal Implant and Annular Repair devices.
• New product introduction;
• Electronic QMS integration into Operations.

• Velocimed designed, developed, and manufactured three very different devices: PFO Closure device (EU and US Class III), Embolic Protection device (EU and US Class II), and a Chronic Total Occlusion Catheter (EU and US.
• Employee #6;
• Concept to Clinicals in less than two years;
• Process and Operational Development;
• Directed Engineering group of 25 employees;
• St. Jude Medical acquired Velocimed for $85M in April, 2005.

• Developed Balloon Angioplasty catheters, Stents and Stent Delivery Systems, and Rotational Atherectomy devices
• Research and Process Development;
• Three excellence awards for process development;
• World-wide evaluation of engineered stent materials;
• Development of secure supply of critical components;
• Supervision of seven engineers and technicians.

Bs Mechanical Engineering

Ba Biology