1. Beth Zielinski, PhD Jeffrey Scott, PhD
Biomaterials 2013

2. The Medical Implant Top Ten List 2012 US
Implantable Cardioverter Defibrillators > Number of procedures: 133,262 > Total annual expenditure: $5.5 billion > Average cost per procedure: $40,000 > Major manufacturer: Medtronic (40%), St. Jude Medical, and Boston Scientific
Artificial Hips > Number of procedures: 230,000 > Total annual expenditure: $10.5 billion > Average cost per procedure: $45,000 > Major manufacturers: Zimmer (24%), Stryker, DePuy/J&J, Biomet, Wright Medical Heart Pacemakers > Number of procedures: 235,567 > Total annual expenditure: $4.5 billion > Average cost per procedure: $20,000 > Major manufacturers: Medtronic (40%), St. Jude Medical, Boston Scientific Breast Implants > No. of procedures: 366,000 > Total annual expenditure: $992 million > Average cost per procedure: $3,351 > Major manufacturers: Allergan, Mentor
Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair) > Number of procedures: 453,000 > Total annual expenditure: $4.5 billion > Average cost per procedure: $2,000-$20,000 > Major manufacturer: Synthes (50%)

3. The Goals of this Course
Basic pathophysiology of several conditions
Repair and replacement options/devices
Structures (including materials) and functions of these options/devices
Relationships between hosts and devices
Facialart.com

4. In More Detail
Device
What function is the device augmenting or replacing?
What are the material design characteristics of the that lend the device as an appropriate alternative to native tissue/organ?
Once in line with host tissue, how will the host tissue respond?
How will the device respond to the new physiological environment?
Will this marriage be a success?

5. History

6. What came first…..
the chicken (device) or the egg (biomaterial)?

7. Historically… The materials existed before the device
Available materials were used to fabricate necessary devices and implants.
Dacron fibres from E.I. DuPont de Nemours & Company, Inc. were the first polyester fibres to gain acceptance by the Food and Drug Administration (FDA) in the U.S.A.-1950
Implanted by Dr. Debakey in 1957
Cleveland Clinic

8. Early Civilizations
2500+ years ago Egyptians, Romans, Chinese and Aztecs
Gold, wood, ivory and gems to replace teeth and fill bone defects
Discoverynews.com
Homeopathicdentristy.com

9.
Repair of lacerated brachial artery using wood and twisted thread
1804 – Steel pins
Development of aseptic techniques

10. Early 20th century 1914 – Steel plates
1924 – First assessment of biocompatibility of metals/alloys
1926 – Stainless steel (18-8) developed
1940 – Ti first used in pacemakers and heart valves
First implanted
pacemaker,
Sweden, 1958

11. Early 20th century Explosion of new materials Jarvik-7 WWI WWII
Celluloid – craniofacial plates
Natural rubbers – synthetic grafts and artificial hearts
WWII
PMMA – craniofacial plates, ocular lenses, vascular grafts
Silicone breast augmentation
Silicone breast
implant
Jarvik-7

12. More recently…
1960 – Biomer (Lycra) – artificial hearts, catheters, ACL repair
1969 – PTFE (Teflon)
1971 – ePTFE – vascular grafts
St. Jude Medical

13. Today Materials developed over last 40-60 years
New materials are being designed with “nanofeatures”
The goal is optimization of the host-material interface
Many devices require combinations of different materials and include drug delivery components
Natural, Synthetic, Combination Products, Regenerated Tissues

14. Rules and Regulations

15. According to the FDA… Medical devices have several components
The FDA/Center for Devices and Radiological Health regulates companies
that design, manufacture, repackage, relabel, and/or import devices but
does not regulate how and which physicians use a device

16. Combination Products
Therapeutic and diagnostic products that combine drugs, devices, and/or biological products
Drug-eluting stent
Nicotine patch
ABCNews.com

17. Medical Device Law
Pure Food and Drug Acts of 1904 did not include provisions for medical devices
Medical Device Amendment of 1976

18. Medical Device Law Subsequent legislation includes:
Safe Medical Device Act of 1990
Quality systems
Post-market surveillance
FDA Modernization Act of 1997
Automatic Class III designation
Fee schedule for shorter reviews
Medical Device User Fee and Modernization Act of 2002
Inclusion of pediatric experts
FDA Modernization Act of 2007
Expanded MDUFMA

19. Medical Device Regulation
Risk-Based Device Classification
Class I -Simple, no risk (latex gloves, arm slings)
Class II -Higher risk devices (catheters)/510(k)
Class III -Highest potential risk (heart valves)/ PMA

20. Journey to Market
FDA.gov
Following approval based upon one of these pathways, devices can still
be subject to post-approval studies

21. Medical Device Regulation Pathways for approval
Investigational Device Exemption (IDE) Allows an investigational device to be used in a clinical study to collect data for safety and effectiveness This is required for a PMA and 510k Pre-market notification application (510 (k)) Medical devices mfg must provide data to demonstrate that the new devices is “substantially equivalent” to a legally marketed device Class I and II devices Premarket Approval (PMA) Medical devices that do not show SE Class III devices; extremely rigorous review process

22. 510 (k) versus PMA

23. 510 (k) versus PMA
Annals of Internal Medicine

24. The Pipeline

25. Human Device Exemption
Commercialization of Class III devices designed to address small markets
Diseases or conditions that effect fewer that 4000 patients in the US/year
Device is safe and probable benefits outweigh probable risks

26. In coming weeks….