1. Founded in 1981

2. Clinically Driven Product Development Professionals

3. Large Corporate Clients

4. Edrich Health Technologies
Axya Medical, Inc
Southern Spine
D C I
Entrepreneurial & Academic Clients

5. General Surgery &
Endoscopy
Cardiovascular
Surgery &
Interventional
Catheters
Spine &
Orthopaedics
Drug Delivery
Urology &
Gynecology
Neurological
Devices
Diagnostics
Ophthalmology
Markets Served

6. Our Capabilities
Specialty Catheter Design
Electronics / Custom Circuit
Board Design
In-House Tissue Testing
Implants
Custom Design
Rapid Prototyping

7. What we do…
Concept Development
Detailed Design
“Voice of Customer” Clinical Feedback
Prototyping
Contract Manufacturing
Procedural Development
Clinical Testing
Industrial Design & Ergonomics Project Management

8. Clinical Support
John Elefteriades, M.D.
Cardiothoracic Surgery
Yale University
University of Maryland
Cadaver Lab In-House Tissue Lab
Acute & Chronic
Animal Testing
Board Certified Veterinarian
Surgeon Consultants
Robert Chapolini, M.D.
University of Maryland
Gross Anatomy Lab
Degreed Biomedical
Engineer

9. The Synectic Process
Phase 1
Project
Definition
Phase 2
Concept
Development
Phase 3
Engineering
Development
Phase 4
DFM / DFA
Phase 5
Product
Validation
Phase 6
Contract
Manufacturing

10. Phase 1 – Project Definition
Phase 1
Phase 2
Concept
Development
Phase 3
Engineering
Development
Phase 4
DFM / DFA
Phase 5
Product
Validation
Phase 6
Contract
Manufacturing
Physician Feedback
IP Review
Market Research &
Competitive Analysis

11. Phase 2 – Concept Development
Phase 1
Project
Definition
Phase 2
Phase 3
Engineering
Development
Phase 4
DFM / DFA
Phase 5
Product
Validation
Phase 6
Contract
Manufacturing
Animal/Cadaver
Testing
Innovative
Brainstorming
Concept
Evaluation
Initial
Breadboard
Fabrication

12. Phase 3 – Engineering Development
Phase 1
Project
Definition
Phase 2
Concept
Development
Phase 3
Phase 4
DFM / DFA
Phase 5
Product
Validation
Phase 6
Contract
Manufacturing
Design
FMEA
Bench Testing
FEA
Clinical
Testing
Detailed
Design

13. Phase 4 – DFM/DFA
Human Factors /
Ergonomics
Manufacturing
Fixture
Development
DFM / DFA
Manufacturing
Component
Fabrication & Sourcing
Design
Verification
Phase 1
Project
Definition
Phase 2
Concept
Development
Phase 3
Engineering
Development
Phase 4
Phase 5
Product
Validation
Phase 6
Contract
Manufacturing

14. Phase 5 – Design Validation
Phase 1
Project
Definition
Phase 2
Concept
Development
Phase 3
Engineering
Development
Phase 4
DFM / DFA
Phase 5
Phase 6
Contract
Manufacturing
Quality & Process
Documentation
Sterilization
Validations
Process
Validations
Transportation
Testing
Biocompatibility
Testing
Packaging Design
& Validations

15. Phase 6 – Contract Manufacturing
Phase 1
Project
Definition
Phase 2
Concept
Development
Phase 3
Engineering
Development
Phase 4
DFM / DFA
Phase 5
Product
Validation
Phase 6
Manufacturing
Line Support
Quality Line
Support
Class 10,000
Clean Rooms

16. The Synectic Product Showcase

17. The Synectic Custom Test Fixture Showcase

18. Why Synectic?
Clinical Focus
Instantaneous
Resource
Client Owns IP
One Stop Shop
Maximize
Innovation
Reduced Time to
Market
Fixed Fee
Proposals

19. Thank You

20. Electrical Capabilities
Joel Helfer
B.S. Electrical Engineering
M.S. Biomedical Engineering
Joel has comprehensive experience utilizing his electrical and biomedical
engineering background in the design and commercialization of a diverse range of
products, such as intra-aortic balloons, neonatal monitors, EKG electrodes,
electrophoresis equipment, and RF devices and generators. Joel was previously
the engineering manager of Kodak Molecular Imaging Systems and founder of
CAS Medical Systems.
Circuit Board Design Gerber File Design Electrical Schematics Perfboard Construction
User Interface Design Software Design Custom Electrical Fixtures