At TechFlex, we specialize in providing cutting-edge hardware solutions for the medical device industry.
In the ever-evolving landscape of the medical device software development solutions.
Ensuring that medical devices meet stringent regulatory standards and are secure against cyber threats.

Empowering Startups in Series A and Seed Money Stages

How TechFlex Works with Startups

TechFlex is dedicated to assisting startups in the Series A and Seed money stages to achieve their objectives through a structured and supportive framework. Our approach focuses on providing tailored solutions that address the unique challenges faced by early-stage companies.

Empowering MedTech Growing Companies Innovators

Transforming Visions into Market-Ready Solutions

TechFlex is the catalyst for success in the medical device industry, offering comprehensive support to growing companies. With expertise spanning from initial concept to market entry, TechFlex provides tailored solutions, cutting-edge technologies, and regulatory guidance.

ACCELERATING
TIME-TO-MARKET
A lengthy development process is delaying the delivery of your innovative medical solutions to the market. We streamline the development process from concept to commercialization, utilizing efficient workflows and expert project management to reduce time-to-market. Learn How
ACCELERATING YOUR MEDTECH
STARTUP WITH RAPID
TECHNOLOGICAL ADVANCEMENTS
Heavy capital investments in specialized equipment and personnel straining your budget? Leveraging project management in the USA and cost-effective development teams in Eastern Europe, TechFlex-Dev delivers high-performance, regulatory-compliant solutions while optimizing your budget. Explore The Solution
HANDLING COMPLEX
DEVELOPMENT CHALLENGES
Need access to a multidisciplinary team of seasoned professionals with extensive experience in medical device development? Our multidisciplinary team of seasoned professionals brings extensive experience in medical device development and provides top-tier expertise across all project phases. Explore The Solution
REGULATORY COMPLIANCE
AND CERTIFICATION FOR
MARKET SUCCESS
Looking for support throughout the development stages to achieve rapid regulatory approval and market success? We support clients through every stage of development to achieve rapid regulatory approval and market success, backed by a proven track record of successful projects and satisfied clients. Explore The Solution
MEDTECH COST MANAGEMENT
& RESOURCE ALLOCATION
Heavy capital investments in specialized equipment and personnel straining your budget? Leveraging project management in the USA and cost-effective development teams in Eastern Europe, TechFlex-Dev delivers high-performance, regulatory-compliant solutions while optimizing your budget. Explore The Solution

ACCELERATING TIME-TO-MARKET A Lengthy Development Process Is Delaying The Delivery Of Your Innovative Medical Solutions To The Market. Learn How We streamline the development process from concept to commercialization, utilizing efficient workflows and expert project management to reduce time-to-market. HANDLING COMPLEX
DEVELOPMENT CHALLENGES
Need access to a multidisciplinary team of seasoned professionals with extensive experience in medical device development? Explore The Solution Our multidisciplinary team of seasoned professionals brings extensive experience in medical device development and provides top-tier expertise across all project phases.
REGULATORY COMPLIANCE
AND CERTIFICATION FOR
MARKET SUCCESS
Looking for support throughout the development stages to achieve rapid regulatory approval and market success? Explore The Stages Our multidisciplinary team of seasoned professionals brings extensive experience in medical device development and provides top-tier expertise across all project phases.
MEDTECH COST
MANAGEMENT & RESOURCE
ALLOCATION
Heavy capital investments in specialized equipment and personnel straining your budget? Explore the ROI Leveraging project management in the USA and cost-effective development teams in Eastern Europe, TechFlex-Dev delivers high-performance, regulatory-compliant solutions while optimizing your budget.
ACCELERATING YOUR
MEDTECH STARTUP WITH
RAPID TECHNOLOGICAL
ADVANCEMENTS

Overcome Medical Device Startup Early-Stage Challenges with Cost-Effective Solutions to Expedite Your Go-to-Market Process. Take Your Startup Forward Fast! Leverage our affordable development teams for your Seed and Series A Stage in Eastern Europe, guided by our professional U.S.-based team with 20 years of regulatory expertise, to accelerate your medical device startup's journey to market.

Drug Delivery System

In developing a system for controlled opiate delivery, TechFlex demonstrated its expertise in creating secure, precise medical devices. By incorporating tamper-resistant features, exact dosage control, and a sophisticated backend system for pharmacists, we’ve addressed critical issues in pain management and drug administration, showcasing our ability to integrate hardware and software solutions for improved patient care.

Transforming Healthcare & MedTech Through Innovation and Expertise

TechFlex-Dev leads the way in MedTech development, offering comprehensive solutions from concept to commercialization. Let us turn your vision into reality with our cutting-edge technology and regulatory expertise.
With over two decades of experience, we have consistently delivered high-quality, compliant, and effective medical devices. Our multidisciplinary team of engineers, designers, and regulatory experts is dedicated to pushing the boundaries of medical technology.

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.

Design Review
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510K Clearances
0 FDA
Cost Saving
$ 0 M+
New PCB Desgin
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Comprehensive Development Solutions
for MedTech

"End-to-End Hardware and Software Development Solutions for Medical Devices"

TechFlex-Dev delivers integrated hardware and software development services tailored for the healthcare and medical device industry, ensuring innovative, compliant, and effective solutions.

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

Growing companies and startups, especially those in the early stages and Series A funding rounds, face several critical challenges that can impede their progress and success in the highly competitive MedTech industry. TechFlex-Dev’s outsourcing team is uniquely positioned to address these pain points effectively:
  • 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.
By partnering with TechFlex-Dev, growing companies and startups can overcome these challenges and achieve their development goals efficiently and cost-effectively. Our proven track record of successful projects and satisfied clients demonstrates our capability to support your journey from early-stage development to market success.

Addressing Key Pain Points for Early-Stage and Series A Startups

Growing companies and startups, especially those in the early stages and Series A funding rounds, face several critical challenges that can impede their progress and success in the highly competitive MedTech industry.
TechFlex-Dev’s outsourcing team is uniquely positioned to address these pain points effectively:

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.

Our proven track record of successful projects and satisfied clients demonstrates our capability to support your journey from early-stage development to market success.

Lung Ventilation System

TechFlex’s development of a compact, versatile ventilator highlights our ability to revolutionize critical care equipment. By creating a single device usable across the care continuum, we’ve addressed size constraints while enhancing functionality through powerful processing and software-driven controls. The unique valve technology, capable of delivering both large and small tidal volumes, showcases our innovative approach to solving complex medical challenges.

TechFlex Team

This combined approach allows TechFlex-Dev to offer cost-effective solutions without compromising on quality. By minimizing the need for heavy capital investments in specialized equipment and personnel, we help manage your budget more effectively. Our development processes are meticulously designed to align with regulatory standards, ensuring your medical devices are compliant, reliable, and market-ready.

Jorg Lorscheider

CEO

25 years experience leading engineering service companies.

Anna Suchard

COO

20+ years software quality assurance and management.

Shepard Bentley

VP Regulatory Affairs

25+ years quality management and regulatory consulting.

Alexandra Barsukova

VP Engineering

Engineering management for over 11 years.
TechFlex-Dev optimizes cost management by leveraging a dual-location strategy. Our project management and account leadership teams are based in the USA, providing seamless communication, alignment with your time zone, and strategic oversight. This ensures that your projects are managed efficiently and meet all regulatory standards, including FDA and ISO requirements. Meanwhile, our highly skilled development teams operate out of several locations in Eastern Europe. This strategic distribution allows us to tap into a pool of top-tier engineering and development talent at significantly lower costs. Eastern Europe offers a competitive pricing structure due to lower operational costs while maintaining high performance and quality standards.

Our Success Stories

Highlighting some of our most successful projects, showcasing our expertise and the impact of our work on the healthcare industry.

TechFlex

TechFlex-Dev optimizes cost management by leveraging a dual-location strategy. Our project management and account leadership teams are based in the USA, providing seamless communication, alignment with your time zone.

Blog And Resources

Insights and Resources

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

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Jorg Lorscheider

CEO

Jorg has been a key leader and board member in the engineering services industry for many years, He has managed and executed all aspects of the business over the years, including Strategy, HR, Business Development, Finance, IT, and Engineering. Jorg is also very active in the medical startup community and has been an advisor to countless startups. Jorg is also chairman for the IVD Linkedin group. His passion is seeing medical developments succeeding to help patients.

PERSONAL: Jorg advises and invests in technologies, Enjoys time with his grown children, Is currently living in Orange County CA and Highland County VA.

HISTORY: Jorg was formerly a world class volleyball player having played for UCSB, USA Jr National Team, USA National Team, and professionally at Thermomec Spa, Padova Italy.

Publication
Patents: US5697811 A
US6077108 A

Anna Suchard

COO
Anna is an entrepreneur with over 20 years of hardware and software development experience. Anna has a thorough understanding of the entire software development life cycle (SDLC) and thus is instrumental in managing our development projects. Anna has extensive experience in creating and managing remote teams and is key to our relationships with our customers and remote teams. Anna has held roles with Dynamic Healthcare systems, CompuGroup Medical, Merge Healthcare, OIS, GE Healthcare, Intel, Given Imaging, and Biosense Webster (Israel).
PERSONAL: Anna lives in Newport Beach with her family. She travels frequently, managing her various business interests.

Shepard Bentley

VP Regulatory Affairs
Shep has guided dozens of companies through the regulatory process and secured clearances in the USA, Europe and Asia. His background in development and manufacturing has given him a view of the entire development process and how quality systems and regulatory compliance intertwine throughout. As a former Lieutenant Colonel in the Marine Corps, Shep enjoys the structure and dynamic nature of the product development, manufacturing and regulatory process. Shep has consulted on regulatory and quality matters for a wide range of companies over the years, including Amgen, Actus Biotech, AfectaPharm, AscentX, BBraun, BioClynse, Biofield, Borimed Pharma, C5, Convoy Biotech, Dental Sciences, EndurX Enteron, HeartHero, ImmutriX, Johnson & Johnson, K18 (Unilever), Pathelen Health Care, Pharmakos, Primal Critical Care, Secant Pharma, Sona NanoTech and many others.
PERSONAL: Shep lives in Laguna Niguel CA Travels frequently to Portugal to visit his family. Shep served in Desert Storm, and Iraq for Enduring Freedom.

Alexandra Barsukova

VP Engineering
Alexandra is our key point of contact with our Eastern European teams. She manages a staff of ~60 engineers to get our engineering and design projects completed on time and on budget. Alex is also an entrepreneur who understands every aspect of the business and how to best staff and control costs within our programs. Her background from being with the Ukrainian research institute for manufacturing engineering gives here a strong experience in how products are not only designed, but also manufactured. Alex also worked at United Engineering, Mobindustry Corp, and startup called Branto. Alex is multidimensional in that she has a deep understanding of electronics, Mechanical engineering as well as firmware and software engineering.
PERSONAL: Alex lives in Dnipro, Ukraine with her partner, son and dog Aston-Martin. She travels to the US yearly to meet with us and our customers.
PUBLICATIONS: Alex Routledge Handbook of Risk Management and the Law; Chapter 23: Quality Management Considerations Routledge / Taylor & Francis Group (New York and London) March 2, 2023
Medical Device Book Internet Of Things for Medical Electronic Device Solutions (MEDS) 1st Ed. June 15, 2015; 2nd Ed. September 15, 2020
Medical Device Labeling: A Universe of Confusion J AMWA vol 34 no 4
So, you think you know about medical devices? J AMWA vol 34 no 2
Finding a Balance in the Assessment of Risk; Genetic Engineering & Biotechnology News (GEN) March 3, 2006 vol 26; no 3