Video Briefs

Regulatory Experts

Howard Holstein Howard Holstein
Regulatory Attorney
Su-Mien ChongSu-Mien Chong
Regulatory Consultant

The Stanford University Biodesign team, through funding from the Kauffman Foundation, has developed a series of video briefs that address important information about medtech regulatory processes and requirements in the U.S. The videos are intended to reinforce and expand upon the regulatory content covered in the Biodesign text. They present content on regulatory basics, fundamental regulatory strategies, and several short case studies on medtech companies and their interactions with the FDA.

Each video brief uses an interview format with Dr. Paul Yock, Director of the Biodesign Program, asking questions of two different regulatory experts. Su-Mien Chong is a seasoned regulatory professional who has worked with multiple companies on obtaining the regulatory approval/clearance of their devices. Most recently, she assisted Acclarent with the regulatory strategy for its Balloon Sinuplasty system. Howard Holstein is a regulatory attorney with over 30 years of experience representing medtech companies, industry associations, and the FDA. Howard is a long-time supporter of the Biodesign program and a contributor to the Biodesign textbook.
Topic ExpertLength
Understanding the FDA [all 7 questions]Howard Holstein16:01 min
         Q1: History of FDA   2:26 min
         Q2: Structure of FDA/CDRH   1:36 min
         Q3: CDRH vs. CDER  1:18 min
         Q4: Device/Drug Combinations   1:52 min
         Q5: External influences on FDA  3:23 min
         Q6: Advice for Innovators  1:49 min
         Q7: CMS and FDA  2:52 min
Working with the FDA [all 9 questions]Su-Mien Chong7:55 min
         Q1: Targeting FDA Branches   1:07 min
         Q2: Who Companies Work with at FDA   0:42 min
         Q3: How Branch makes a Difference   0:47 min
         Q4: When to Interact with FDA   0:46 min
         Q5: Benefits of Meeting with FDA   0:52 min
         Q6: Developing a Relationship with FDA   1:22 min
         Q7: Downside to Meeting with FDA   0:46 min
         Q8: Case Study: Building a Relationship   1:00 min
         Q9: Other Advice   0:20 min
First Steps in the Regulatory Process [all 9 questions] Su-Mien Chong 11:40 min
         Q1: What Should Innovators Think About
 1:12 min
         Q2: Classification of a Device
 1:09 min
         Q3: Navigating the Pathway Decision
 1:40 min
         Q4: Using the De Novo Pathway
 0:34 min
         Q5: Choosing a Predicate
 1:03 min
         Q6: 510(k) and Market Potential   0:51 min
         Q7: Investigational Device Exemption
  1:28 min
         Q8: Pointers for Submissions
   2:00 min
         Q9: How to Approach the Assignment of a Panel
  0:56 min
Assembling a Regulatory Team [all 6 questions]Su-Mien Chong5:50 min
         Q1: Guiding Principal: Building a Team   0:36 min
         Q2: Internal vs. External Regulatory Help   1:03 min
         Q3: Timing for Regulatory Assistance   0:34 min
         Q4: What to Look for in a Consultant   1:32 min
         Q5: How to Find/Hire a Consultant   0:49 min
         Q6: Working with a Consultant   0:53 min
510(k) vs. PMA Regulatory Strategies [all 6 questions]Howard Holstein 14:14 min
         Q1: Basics of 510(k) Clearance Process   2:19 min
         Q2: Concerns about 510(k) Process   2:19 min
         Q3: Basics of PMA Approval Process   0:51 min
         Q4: Key Differences: 510(k) vs. PMA   2:52 min
         Q5: Approaching FDA w/Multiple Areas   3:21 min
         Q6: Care as Device Moves to Market   2:00 min
Investigational Device Exemptions [all 5 questions]Howard Holstein10:07 min
         Q1: Need for Clinical Trials   0:53 min
         Q2: US vs. Outside US trials   1:29 min
         Q3: Role of Investigational Device Exemption   2:28 min
         Q4: Need for Meeting w/FDA prior to IDE   2:00 min
         Q5: Advice for FDA Meetings prior to IDE   2:32 min
Case Example: The Acclarent Regulatory Strategy [all 14 questions]
Su-Mien Chong8:50 min
         Q1: About Acclarent   0:35 min
         Q2: About Balloon Sinuplasty   0:42 min
         Q3: Acclarent's Regulatory Strategy Timing   0:39 min
         Q4: Determining Branch at FDA   0:16 min
         Q5: Determining Device Classification   0:30 min
         Q6: Determining Regulatory Pathway   0:48 min
         Q7: Reasons to Choose 510(k)   0:13 min
         Q8: Concerns with Chosen Pathway   0:16 min
         Q9: Choosing Predicates   0:46 min
         Q10: 510(k) Submission Experience   0:45 min
         Q11: Clinical Data Requirements   0:17 min
         Q12: First Interaction with FDA   0:42 min
         Q13: Time to Clearance   0:37 min
         Q14: Post Approval Analysis   1:00 min
Regulatory Case Studies [all 4 questions]Howard Holstein7:35 min
         Q1: Perclose: 510(k) vs. PMA   2:35 min
         Q2: Neuroretrieval Devices: Pathway Strategy   1:37 min
         Q3: Emphasys: Expert Panels   1:33 min
         Q4: Cyberonics: Overcoming Panel Recommendations   1:11 min

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