ATech Designs, Inc.
Engineering and consulting firm providing end-to-end medical device product design, prototyping, testing, and manufacturing support. Services include design for manufacturing, materials selection, process validation for injection molding, precision machining and assembly in controlled environments, clinical and animal study support, and expert witness services. The company documents and validates development work to FDA/GMP/ISO standards.
Industries
Nr. of Employees
small (1-50)
ATech Designs, Inc.
Products
Face shields and KN95 face masks
Personal protective equipment offered through an online shop (face shields and KN95 masks).
Needle-free IV valve
Needle-free intravenous valve device used for closed IV access and fluid transfer.
Needle-scopic percutaneous suturing devices
Minimally invasive suturing devices designed for percutaneous and laparoscopic procedures.
Laparoscopic suturing device for hernia repair
Device designed for laparoscopic suturing applications such as hernia repair.
Minimally invasive mitral valve repair device
Minimally invasive device for treatment of mitral regurgitation developed for reduced invasiveness and complication risk.
Percutaneous suture locker and tissue anchor
Implantable/percutaneous devices for securing tissue and locking sutures in minimally invasive procedures.
Face shields and KN95 face masks
Personal protective equipment offered through an online shop (face shields and KN95 masks).
Needle-free IV valve
Needle-free intravenous valve device used for closed IV access and fluid transfer.
Needle-scopic percutaneous suturing devices
Minimally invasive suturing devices designed for percutaneous and laparoscopic procedures.
Laparoscopic suturing device for hernia repair
Device designed for laparoscopic suturing applications such as hernia repair.
Minimally invasive mitral valve repair device
Minimally invasive device for treatment of mitral regurgitation developed for reduced invasiveness and complication risk.
Percutaneous suture locker and tissue anchor
Implantable/percutaneous devices for securing tissue and locking sutures in minimally invasive procedures.
Services
Concept-to-production medical product design, requirements capture, market analysis, patent search support, and development of documented design history files following FDA/GMP/ISO practices.
Technical expert services for patent and liability litigation including document review, lab testing, reports, depositions and trial testimony.
Design and build of manufacturing automation equipment from fixtures to custom lights-out systems.
Materials evaluation and recommendations considering chemical resistance, mechanical properties, processing and joining methods for medical applications.
Detailed CAD modeling, drawing production and CAD file translation across common industry formats.
Structural, contact, electromagnetic and thermal simulation for component and system analysis.
Concept-to-production medical product design, requirements capture, market analysis, patent search support, and development of documented design history files following FDA/GMP/ISO practices.
Technical expert services for patent and liability litigation including document review, lab testing, reports, depositions and trial testimony.
Design and build of manufacturing automation equipment from fixtures to custom lights-out systems.
Materials evaluation and recommendations considering chemical resistance, mechanical properties, processing and joining methods for medical applications.
Detailed CAD modeling, drawing production and CAD file translation across common industry formats.
Structural, contact, electromagnetic and thermal simulation for component and system analysis.
Expertise Areas
- Medical device product development
- Design for manufacturing and assembly (DFMA)
- Prototype fabrication and short-run molding
- Injection molding process validation
Key Technologies
- Computer-aided design (CAD)
- Finite element analysis (FEA)
- Stereolithography (SLA) 3D printing
- Rapid injection molding
News & Updates
Company acted as engineering partner for a client that received CE mark and approval to sell a minimally invasive mitral valve device in Europe (effective April 1, 2021 to May 27, 2024).
Award recognizing the company's expert witness services in medical device litigation.
Multiple articles and press coverage related to product development and clinical testing (archived posts from 1998 onward).
Recipient of Medical Design Excellence Awards and other industry recognitions for product designs.
Company acted as engineering partner for a client that received CE mark and approval to sell a minimally invasive mitral valve device in Europe (effective April 1, 2021 to May 27, 2024).
Award recognizing the company's expert witness services in medical device litigation.
Multiple articles and press coverage related to product development and clinical testing (archived posts from 1998 onward).
Recipient of Medical Design Excellence Awards and other industry recognitions for product designs.