0
FDA: Where Are We Now?
DiabetesMine Innovation Summit
November 15, 2013
Courtney H. Lias, Ph.D.
Director, Division of Chem...
Who Are We?
Division of Chemistry and Toxicology Devices
Director – Courtney Lias

Diabetes Diagnostics Devices Branch
Bra...
Diabetes
People with diabetes face many challenges:
• Immediate risks everyday due to potential for severe hypo- and hyper...
CDRH Innovation Pathway
•FDA developed mechanism to encourage innovation
•Shorten the time and cost to market for innovati...
CDRH Innovation Pathway
•Though pilot is still ongoing in kidney disease, this concept can be applied
now to diabetes devi...
Glucose Meters
• Premarket clearance of glucose meters – data review
• Improvements in accuracy over the last 3-4 years
• ...
Postmarket Safety
• >25,000 Medical Device Reports/year for blood glucose meters
• Variability in quality of reporting, de...
Continuous Glucose Monitors (CGMs)
• CGMs are home use devices that continuously measure
glucose in interstitial fluid
• H...
Artificial Pancreas
• The development of an Artificial Pancreas will improve outcomes for people
with diabetes
• Challenge...
Artificial Pancreas
• First step recently approved
• Medtronic 530G Threshold Suspend System
• 530G pump
• Enlite CGM
• In...
Mobile Applications
• To facilitate new technologies, mobile platforms are key
• Nearly everyone now carries a cell phone
...
New Technologies
Needed Quality of Life Improvements:
• Consolidation of devices (meters, pumps, lancets, cell phones, etc...
New Programs/Changes
• Joined the 21st century (electronic submissions)
• Town hall meetings
• Artificial Pancreas public ...
Patient Interaction
• Efforts to better reach Patients
• FDA is trying to find ways to increase input from patients so tha...
What Can You Do?
• Patients:
• Report adverse events (to the manufacturer and the FDA)
• Comment to the Docket
• Become in...
Upcoming SlideShare
Loading in...5
×

Courtney Lias FDA Presentation - DiabetesMine Innovation Summit 2013

877

Published on

Courtney Lias, Director,Division of Chemistry and Toxicology Devices, FDA, gave a keynote talk at the 2013 DiabetesMine Innovation Summit at Stanford School of Medicine on Nov. 15, 2013.

Published in: Health & Medicine, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
877
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
20
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Transcript of "Courtney Lias FDA Presentation - DiabetesMine Innovation Summit 2013"

  1. 1. FDA: Where Are We Now? DiabetesMine Innovation Summit November 15, 2013 Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Food and Drug Administration
  2. 2. Who Are We? Division of Chemistry and Toxicology Devices Director – Courtney Lias Diabetes Diagnostics Devices Branch Branch Chief – Katherine Serrano (Acting Branch Chief – Stayce Beck) • 44 staff and managers in the Division • Premarket (clearance/approval) and Postmarket (recalls, inspections, surveillance,…) • Approximately 40-45% of Division work is directly Diabetes-related • • • • • • • Blood Glucose Meters Point-of-Care glucose analyzers Central Laboratory analyzers Blood gas analyzers HbA1c tests Continuous Glucose Monitoring Systems (CGMs) Artificial Pancreas Systems • Other Divisions – insulin pumps (not CGM-enabled), insulin pens, lancets, etc.
  3. 3. Diabetes People with diabetes face many challenges: • Immediate risks everyday due to potential for severe hypo- and hyperglycemia • Long-term heath risks due to glycemic variability and hyperglycemia • Quality of life challenges • The need for multiple devices (meters, pumps, insulin pens, lancets, etc…) • Pain at lancing and injection sites • Complicated drug dosing and nutrition decisions • Data overload can be frustrating (e.g., CGM data) • etc… Needs: • Devices that improve lives without adding complexity • Simple, easy to interpret device data outputs • Easy to use, safe, and effective medical products
  4. 4. CDRH Innovation Pathway •FDA developed mechanism to encourage innovation •Shorten the time and cost to market for innovative (and other) medical devices •Transform how FDA and innovators work together •Pilot program underway (chronic kidney disease) •Goal = creative approaches to fulfill regulatory needs while advancing innovative product development Application Process Collaboration Phase Clinical Trials Phase FDA Conference Center IT Tools Market Approval
  5. 5. CDRH Innovation Pathway •Though pilot is still ongoing in kidney disease, this concept can be applied now to diabetes devices •The attitude: •What is right for the patient? •What makes sense to get there? Application Process Collaboration Phase Clinical Trials Phase FDA Conference Center IT Tools Market Approval
  6. 6. Glucose Meters • Premarket clearance of glucose meters – data review • Improvements in accuracy over the last 3-4 years • Improvements in interference detection • Conversion away from GDH-PQQ technologies • ISO 15197 updated, POCT-12 published • FDA to publish blood glucose meter guidance These improvements have made patients safer, and they will continue
  7. 7. Postmarket Safety • >25,000 Medical Device Reports/year for blood glucose meters • Variability in quality of reporting, decision-making at firms Challenges • High volume of data • Low quality data • Inconsistent compliance Solutions • New methods for data analysis • Developing guidance for manufacturers • Clarify reporting criteria/methodology • Increase consistency across manufacturers • Potential new surveillance program?
  8. 8. Continuous Glucose Monitors (CGMs) • CGMs are home use devices that continuously measure glucose in interstitial fluid • Have demonstrated benefit for the patients that use them • Recent Approvals • DexCom G4 • Medtronic Enlite (part of 530G system) • Challenges remain: • Sensor accuracy needs improvement • New materials/technologies to reduce sensor biofouling needed • Improved reliability needed (e.g., signal dropout) • Better standards would help advance technology
  9. 9. Artificial Pancreas • The development of an Artificial Pancreas will improve outcomes for people with diabetes • Challenges: • Many still struggle to maintain good glycemic control • Hypoglycemic unaware individuals at risk • Risk of nighttime hypoglycemia • Better quality of life needed • Current challenges to get there: • Device limitations – pump imprecision, sensor inaccuracy/unreliability • Biology – complicated • Inter-individual variability – one size fits all possible? Smart algorithms? • Brilliant people working on these problems….
  10. 10. Artificial Pancreas • First step recently approved • Medtronic 530G Threshold Suspend System • 530G pump • Enlite CGM • In-clinic data submitted • Manufacturing concerns • Medtronic working to improve quality • cGMP Variance granted • Post Approval study • FDA requested Pediatric access in the Post Approval study
  11. 11. Mobile Applications • To facilitate new technologies, mobile platforms are key • Nearly everyone now carries a cell phone • Enable functions to allow for medical device interaction from that platform • Challenges include • Security, hacking – specialized communication protocols essential • Android vs. Apple OS • Mechanisms for verification of software/OS updates and upgrades • FDA: • Is working closely with industry on requirements/process for market entry, upgrades, etc. – need to reach the right regulatory touch • Has already cleared/approved many apps in for use with diabetes devices • Published final guidance on Mobile medical Apps – provides more clarity and transparency (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf) • Promises to be more convenient for patients
  12. 12. New Technologies Needed Quality of Life Improvements: • Consolidation of devices (meters, pumps, lancets, cell phones, etc.) • Easy data interpretation, standard data format and metrics • Consolidation of software/applications • Remote upload/data access capabilities (cloud computing) • Easier/faster download capabilities • Improved patient interaction with healthcare professionals
  13. 13. New Programs/Changes • Joined the 21st century (electronic submissions) • Town hall meetings • Artificial Pancreas public meeting • Outreach - has helped us to reach a broader audience (patients, tech developers, etc.)
  14. 14. Patient Interaction • Efforts to better reach Patients • FDA is trying to find ways to increase input from patients so that we can do a better job of taking the patient perspective when making premarket and postmarket decision. • The patient portal is an attempt to create better communications with the community - too soon to know how it will help • We get a lot of perspective from working with patients: • face to face discussions • Conferences • working with investigators and their patients, etc. • Grassroots efforts (e.g., #StripSafely campaign) • If our goals are aligned, can support our efforts • If not aligned or in sync, they can hurt policy implementation • Good communication is key
  15. 15. What Can You Do? • Patients: • Report adverse events (to the manufacturer and the FDA) • Comment to the Docket • Become informed on the facts (from all perspectives) • Focus pressure in the right place • Payers: • Engage in the discussion with FDA and industry • how to get technologies to the patients • what data are needed to support coverage • Industry: • Work together! • Standardize communication between devices • Patients are demanding devices that can safely be used together, and only with cooperation can we develop smooth paths to market
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.

×