Drug Delivery System
Transforming Healthcare & MedTech Through Innovation and Expertise
Access to Specialized Expertise
Our team includes seasoned professionals with extensive experience in medical device development, ensuring top-tier expertise across all phases of your project.
Cost Efficiency
Outsourcing to TechFlex-Dev reduces the need for significant capital investment in specialized equipment and personnel, resulting in substantial cost savings.
Regulatory and Compliance Excellence
With a robust understanding of FDA, ISO, and other regulatory requirements, we ensure that your products meet all necessary compliance standards, minimizing risks and delays.
Cutting-Edge Technology Integration
We leverage the latest advancements in IoT, AI, and digital health, ensuring your products are innovative and future-proof.
Proven Track Record
Our history of successful projects and satisfied clients demonstrates our capability to handle complex development challenges effectively.
Comprehensive Development Solutions
for MedTech
"End-to-End Hardware and Software Development Solutions for Medical Devices"
Hardware Development
Advanced Engineering
Our team excels in the design and development of advanced medical device hardware, including sensors, PCBs, and durable enclosures tailored to meet stringent industry standards.
Rapid Prototyping
We utilize state-of-the-art technologies to create functional prototypes quickly, enabling thorough testing and validation to meet regulatory requirements.
Production Support
From concept to production, we provide comprehensive support to ensure your medical devices are market-ready and compliant with FDA and ISO standards.
Custom Software Development
Custom Medical Software
We develop bespoke software solutions for medical devices, including embedded systems, patient management applications, and cloud-based data platforms.
System Integration
Ensuring seamless integration with existing healthcare IT systems, such as EHR/EMR platforms, to enhance interoperability and streamline workflows.
Compliance and Security
Our software solutions adhere to HIPAA regulations, ensuring data privacy and security, and meet CE and FDA guidelines for medical software.
Why Growing Companies and Startups Should Use TechFlex-Dev's Outsourcing Team
Addressing Key Pain Points for Early-Stage and Series A Startups
- Pain Point: Startups often lack the extensive resources required for comprehensive medical device development.
- Solution: TechFlex-Dev provides access to a multidisciplinary team of seasoned professionals, reducing the need for significant capital investment in specialized equipment and personnel.
- Pain Point: Managing budget constraints while striving to develop high-quality products can be a significant challenge.
- Solution: Our dual-location strategy leverages cost-effective development teams in Eastern Europe, optimizing your budget without compromising on quality. This approach allows startups to allocate their funds more efficiently and invest in critical areas of growth.
- Pain Point: Accelerating time-to-market is crucial for gaining a competitive edge and achieving rapid regulatory approval.
- Solution: TechFlex-Dev streamlines the development process from concept to commercialization, utilizing efficient workflows and expert project management to reduce time-to-market. Our rapid prototyping capabilities ensure thorough testing and validation, meeting regulatory requirements swiftly.
- Pain Point: Navigating the complex landscape of regulatory compliance can be daunting for startups.
- Solution: With over two decades of experience, our team ensures that your products meet all necessary compliance standards, including FDA, ISO, and CE guidelines. This minimizes risks and delays, providing peace of mind and a clear path to market.
- Pain Point: Startups may lack access to specialized expertise in medical device development.
- Solution: Our team includes experts in advanced engineering, software development, and regulatory compliance. This comprehensive expertise ensures that your projects are handled with the utmost professionalism and technical proficiency.
Addressing Key Pain Points for Early-Stage and Series A Startups
Limited Resources
MedTech Startups often lack the extensive resources required for comprehensive medical device development.
TechFlex-Dev provides access to a multidisciplinary team of seasoned professionals, reducing the need for significant capital investment in specialized equipment and personnel.
Budget Constraints
Managing budget constraints while striving to develop high-quality products can be a significant challenge.
Our dual-location strategy leverages cost-effective development teams in Eastern Europe, optimizing your budget without compromising on quality. This approach allows startups to allocate their funds more efficiently and invest in critical areas of growth.
Time-to-Market Pressures
Accelerating time-to-market is crucial for gaining a competitive edge and achieving rapid regulatory approval.
TechFlex-Dev streamlines the development process from concept to commercialization, utilizing efficient workflows and expert project management to reduce time-to-market. Our rapid prototyping capabilities ensure thorough testing and validation, meeting regulatory requirements swiftly.
Regulatory Compliance
Navigating the complex landscape of regulatory compliance can be daunting for startups.
With over two decades of experience, our team ensures that your products meet all necessary compliance standards, including FDA, ISO, and CE guidelines. This minimizes risks and delays, providing peace of mind and a clear path to market.
Access to Expertise
Startups in the MedTech Industry may lack access to specialized expertise in medical device development.
Our team includes experts in advanced engineering, software development, and regulatory compliance. This comprehensive expertise ensures that your projects are handled with the utmost professionalism and technical proficiency.
Lung Ventilation System
TechFlex Team
Jorg Lorscheider
CEO
Shepard Bentley
VP Regulatory Affairs
25+ years quality management and regulatory consulting.
Our Success Stories
TechFlex
Blog And Resources
Insights and Resources
FDA approves lab-grown salmon
Wildtype’s ‘cultivated’ fish is the first of its kind to get the green light.
Read the full article at: www.popsci.com
The Shifting to Subcutaneous Oncology: Recent FDA Approvals
Panelists discuss how the shift from intravenous (IV) to subcutaneous (SubQ) drug administration is transforming oncology care delivery, highlighting its lasting impact on patient experience, health care efficiency, and clinical workflows in light of recent FDA approvals and evolving…
Read the full article at: www.ajmc.com
Route 92 announces presentation of SUMMIT MAX results and gains new US FDA clearance for reperfusion system
Today, Route 92 Medical has announced positive results from its SUMMIT MAX randomised controlled trial (RCT) comparing the efficacy and safety of the HiPoint reperfusion system, including the super-bore 0.088-inch HiPoint 88 aspiration catheter, to a conventional 0.074-inch catheter.
Read the full article at: neuronewsinternational.com
Oxford Brain Diagnostics to roll out revolutionary dementia technology following UK and US regulatory approvals
Oxford Brain Diagnostics (OBD) is preparing to launch its groundbreaking technology for the early diagnosis of dementia across the UK and US healthcare markets, following a wave of key regulatory approvals that mark a major milestone in the company’s growth.
Read the full article at: bmmagazine.co.uk
Trax Surgical Receives FDA 510(k) Clearance for Nitinol Staple System – Ortho Spine News
The LINKT™ System is comprised of a nitinol implant and deployment tools STOUGHTON, Mass., May 19, 2025 /PRNewswire/ — Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market, announced today that they received FDA 510(k) clearance to market the LINKT™ Compression Staple System. The staple system offers a range of nitinol staples for fracture repair, joint fusion, and osteotomy procedures. Compression bone staples have a key intraoperative advantage in that they are technically easier and faster to apply as fewer steps are required. This is an important option for surgeons to have when assessing the needs of their patients. Trax Surgical’s nitinol staple with inherent compressive properties creates a stable environment that promotes bone healing. “We are incredibly excited about this advancement,” said Shane Shankle, President of Trax Surgical. “The approval of our Nitinol Compression Staple enables us to better serve our customers and elevate the standard of care in extremity orthopedics. It reflects our dedication to innovation, quality, and the needs of both surgeons and patients.” The LINKT Compression Staple System is an improvement over some outdated designs that lack the ability to adjust the staple prior to implantation. The LINKT System features an adjustable inserter that allows the surgeon to open and close the staple’s legs for easy insertion. Multiple staples can be deployed with an appropriately sized inserter, which is also used to properly seat the implant, or to remove and reposition it. The company’s nitinol staples have a slightly curved bridge designed to provide more even compression across the fusion site and feature toothed legs for secure fixation. LINKT Staples are available in multiple bridge widths and leg lengths. The LINKT system is comprised of staples sold individually in sterile packaging, and sterile deployment kits comprised of a drill, drill guide, locating pins, and inserter. About Trax Surgical Trax Surgical manufactures innovative medical instrumentation and implant devices for surgical procedures involving the upper and lower extremities. They engineer premium medical products with patient comfort and durability in mind for internal fixation, reconstruction, and more. Bone and fracture repair products from Trax Surgical are quality-assured and certified to industry standards. The Trax Compression Screw System was initially developed by Primo Medical Group. Trax Surgical partners with Primo Medical Group to deliver innovative new products and medical devices certified to industry standards for surgical procedures. About Primo Medical Group Primo Medical Group offers the most comprehensive outsourcing solutions for the medical device market, including OEM product distribution services, engineering services, precision component production, finished goods assembly, medical device refurbishment, reusable surgical kit management and complete supply chain management. Established in 1953, Primo Medical Group is a privately held company with five facilities in Massachusetts. Primo Medical Group is an FDA Registered Contract Manufacturer and is compliant with FDA Quality Systems Regulations. Primo Medical Group is also ISO 13485:2016 certified and is a registered manufacturer with the Office of Defense Trade Controls Compliance. Over the past 24 years Primo Medical Group has incubated and co-funded several new technologies including Angiolink, (acquired by Medtronic), Arthrosurface, Spirus Medical, (acquired by Olympus), Cardiosolutions, Saphena Medical (Acquired in 2024), Versago Vascular Access, Trax Surgical, and Solid State Marine. Contact: Andrea PatisteasSenior Executive Vice PresidentTrax Surgical SOURCE Trax Surgical
Read the full article at: orthospinenews.com
LUCAS technology revolutionizes rapid viral diagnostics
Mass General Brigham researchers are shining a powerful new light into the viral darkness with the development of Luminescence CAscade-based Sensor (LUCAS), a rapid, portable, highly-sensitive diagnostic tool for processing complex biological samples.
Read the full article at: www.news-medical.net
