Medical Device MFG: Avoiding Common Pitfalls and Strategies for Success

Medical Device Manufacturing: Avoiding Common Pitfalls and Strategies for Success

Whether you’re an entrepreneur with a great idea, a designer with a product you’re ready to take to market, or a manufacturing company with an interest in entering the medical device manufacturing industry or expanding your product lines, a deep understanding of regulatory requirements, quality control, and associated risks, is required to succeed.

Join the Global Center for Medical Innovation (GCMI) and Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech on June 25th to learn about the unique challenges that many face when entering the medical device space and the steps you can take to help avoid common pitfalls and achieve success.

During this one-hour webinar, we’ll cover:

• An overview of medical device regulatory requirements, including how the regulatory pathway varies for different medical device classifications.
• Common pitfalls and obstacles that designers or manufacturers encounter when taking their product to market.
• An overview of Quality control requirements and how to achieve compliance with regulations such as ISO 13485 and FDA requirements.
• The importance of design for manufacturability, planning for changes in your supply chain, and including the right partners early in your process to help you scale your product efficiently and minimize setbacks.

Speakers:

Saylan Lukas, Interim Executive Director of the Global Center for Medical Innovation (GCMI), research faculty member of Georgia Institute of Technology.

Saylan has 18 years of medical device design and development experience. From startup companies to large international corporations, he has led project teams from initial feasibility through global commercialization in areas of patient specific craniomaxillofacial implants and instruments, transcatheter heart-valve stent grafts and delivery systems, cranial stabilization systems, cancer treatment devices, and laparoscopic instruments. He has developed and launched multiple products, obtained successful FDA approval on several 510(k) applications, has been awarded multiple patents, and published several technical papers in peer-reviewed journals.

Saylan earned his undergraduate and graduate degrees in Mechanical and Biomedical Engineering from Rose-Hulman Institute of Technology (Terre Haute, IN) and a Master’s in Business Administration from Butler University (Indianapolis, IN).

Dean Hettenbach, GaMEP Project Manager, Supply Chain and Manufacturing Technology, MedTech, Strategy and Leadership Development

Dean helps clients turn technology, supply chain, and manufacturing strategies into deliverables that impact how clients operate, scale, and compete. He utilizes knowledge gained through his past experience delivering solutions across a diverse customer base of start-ups, emerging growth, and Fortune 500 companies, including manufacturers of all types and in many different verticals.

He holds an M.S. in Industrial and Systems Engineering from Georgia Tech, a B.S. in Industrial Engineering from the University of Missouri, and a Certificate in Computer Integrated Manufacturing from Georgia Tech.