MedDevice Development: San Jose, CA

Stacey Hawkins

Date: 09/25/2017
Time: 9:00 am  to  4:30 pm

MedDevice Development Primer

DateSept 25, 2017
Time9:00 am – 4:30 pm
Fee$695 USD | MedTech Conference Attendees $595 USD
LocationSan Jose Marriott, 301 S Market St,San Jose, CA 95113
ExtrasLunch and all course materials included
MedDevice Development Primer

MedDevice Development Primer is a one-day preparatory course for those interested in learning more about the MedTech industry. Examining all aspects of medical device development, the course explains the five phases of medical device development – market opportunity, market evaluation, product design, product verification, and product manufacturing. The course ends with a discussion of the different regulatory pathways and a comparison of FDA vs. EU approval processes. Develop an understanding of the requirements needed to bring a new medical device to market.


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Medical Device Overview 9:00–9:30
Medical Device Defined
Medical Device Diversity

Medical Device Regulations 9:30–10:30
Quality System Regulations (QSRs)
Current Good Manufacturing Practices
Good Laboratory Practices
Good Clinical Practices
Risk Management Plan
Rest Of World Approval Pathways
Special Categories:
Home Brew & Combination Devices

Break 10:30–10:45

Medical Device Regulations continued
Regulatory Challenges
New Technologies
Clinical Trails
Medical Device Reporting

Lunch Provided 12:00–1:00


Medical Device Development 1:00–3:00
Phase I: Market Opportunity Evaluation
Market Analysis
Risk Management Plan
Phase II: Concept Evaluation
Formulation Steps
Phase III: Engineering Design Process
Design & Development
Software Development
Phase IV: Verification
Phase V: Manufacturing Transfer
Equipment IQ/OQ/PQ
Shipping & Storage

Break 3:00–3:15

Medical Device Approval 3:15–4:15
Clinical Trials
Need For A “Gold Standard”
Regulatory Submissions
Coding & Reimbursement

Q&A/Review 4:15–4:30


Jim Macemon

Medical Device Expert | Instructor

Mr. Macemon is a medical device executive with extensive experience in diagnostics, critical care, patient monitoring, imaging, and lab products. During his 30+ year medical device focused career, he led numerous Research & Development and manufacturing teams, successfully launching products to aid laboratory and health care professionals and improve patient care.

Mr. Macemon received his undergraduate degree in engineering from Georgia Institute of Technology, followed by a Masters in Administrative Science from The Johns Hopkins University. During his career, he held senior positions with such companies as Baxter Healthcare, Richardson-Vicks, and SpaceLabs Medical, leading programs to develop laboratory and point-of-care diagnostic systems. Mr. Macemon’s focus during the last 15 years has been with Venture Capital funded start-up companies developing revolutionary diagnostic and imaging technology.

Mr. Macemon’s experience as a trainer also spans many decades. As an invited speaker at several Q1 Productions Medical Device conferences, he spoke on a variety of topics related to product development, quality and manufacturing. And during his 14 years at Baxter Healthcare, he frequently provided customer, company and trainer training covering a variety of product and Quality Management System topics.
Currently Mr. Macemon is Chief Operating Officer at nanoMR, leading the development and manufacturing program for a device that will enable pathogen identification from a whole blood sample in less than 2 hours, enabling clinicians to prescribe appropriate antibiotics for their septic patients days sooner than is possible with current technology.

Refund Policy

All courses and products are final sale. No refunds are given. However, if you cannot attend, you may send someone in your place by notifying Sheila Wagner,, no later than one week before the start date of the class. With the purchase of this course, you will automatically be registered for our WEEKLY. You will receive this free educational newsletter, conveying the science behind the headlines, every Thursday. You may unsubscribe with one click at anytime.