April 2022

There are only a handful of companies that can do what we do. HDA Technology (HDA) has the experience and ability to take your medical device product from concept to shipping. Our decades of experience in medical device manufacturing uniquely positions us as an industry-leading, full-service medical device developer.

HDA provides full development and manufacturing services to companies ranging from medical startups to multinational healthcare corporations. Our FDA-registered facility specializes in developing and manufacturing Class I, II, and III medical devices. And we have a track record of success on even the most technical challenges. HDA can help your company navigate the complexities of prototype development and testing, and scale manufacturing to meet your production goals.

HDA has the expertise and know-how to guide your company through the complete lifecycle of your medical device product. We support our customers with a robust, expert product development team that quickly and competently moves each product through each stage of the process:

• Device Design Controls
• Proof of Concept Prototyping
• Pre-compliance Evaluation & Testing
• Device Design & Engineering Support
• Lab Testing & Verification
• Manufacturing Plan and Processes
• Volume Manufacturing
• Post-Market Support and Service

Our commitment to advancing medical device manufacturing with quality, safe products has made HDA one of the leading medical device development companies in Southern California. Partner with us to turn your medical device concept into reality.

Develop Your Concept

HDA Has Developed Consistent, Effective Design Controls for Medical Devices

The FDA strictly enforces regulations that reduce the likelihood of medical devices and healthcare-related harming consumers. Additionally, their quality system regulation requires medical device manufacturers to establish and adhere to controls through the development process.

Our development team streamlines product development and regulatory certification by implementing efficient, quality-preserving design controls. These design controls inform our processes throughout the development and manufacturing of your product, guaranteeing that the finished product is safe and effective.

As an ISO13485, FDA, and FDB-certified medical device manufacturer, HDA has helped countless companies meet FDA design control standards. By placing the needs of the user first, HDA guarantees that the product is FDA-compliant: 

• What are the needs of the user?
• Does the device meet the user’s needs?
• Does the device present any safety concerns?

Failing to address these questions can lead to significant setbacks in product development. Through years of hands-on experience in product development, HDA has developed a proven process for successful validation.

HDA Documents Development Step-by-Step

We focus on forming device design controls early in the development process to mitigate challenges in the later stages of production. Evidence-supported development and strategies inform the unique design specifications of a medical device product.

HDA uses medical device design controls to create a design history file (DHF) for your product. In addition, we maintain comprehensive documentation that confirms the functional, technical, and regulatory requirements of the design and development, and manufacturing processes to produce the product consistently.

Our thorough documentation includes a product-specific DHF which tracks the design controls process and product development:

• Design and Development Process

 We create and include a unique design plan for your product. The design plan reflects the standard and procedures of our established design controls. 

• Design Input

We develop and include procedures that outline the intended function or use of the medical device. The user’s needs are highlighted to provide a critical function and design goal for the finished product. 

• Design Output

We define and document procedures for determining design output compliance with the design input requirements. The design output procedure contains acceptance criteria that prove the proper functioning and effectiveness of the product.

• Design Process

We develop and include a procedure for reviewing the design process to confirm thoroughly conducting the reviews.

• Design Verification

We develop and include our verification and testing process throughout the product’s development. 

• Design Validation

We develop and include a procedure that defines the testing conditions and criteria used to validate the product design. The results of the validation process are also included to support DHF further.

• Design Production Transfer

We develop and include documentation on the product specifications as they comply with design controls and FDA standards. The documentation consists of procedures necessary to transfer the product to production.

• Design Changes

We document and include design changes as they occur throughout the development of the product. These changes reflect our adherence to the established design controls and support the conventional effect of your medical device.

HDA optimizes the development process by establishing crucial standards and procedures to reproduce your device’s specifications and critical functions. Our strict adherence to design controls results in high-quality products and swift regulatory certification.

At HDA, device design controls are essential for verification and validation processes. Both processes are distinctly different and crucial to ensuring that a product is safe, effective, and regulatory sufficient.

Partner With Us

HDA Verification Guarantees Consistent, Effective Products

Our verification process is structured to ensure that the design of your medical device meets its established requirements for safety and effectiveness. Verification is all about testing that our design outputs match our design inputs.

HDA actively verifies that design outputs meet the established design controls throughout the development process. Identifying discrepancies between the device design and management is crucial to correcting production issues before making it into the later stages of development.

Led by expert medical device design engineers, our verification process can test prototypes, systems, sub-systems, components, raw materials, and software for issues that don’t satisfy the design controls. 

By utilizing the design controls as a guiding template, HDA practices design verification to test:

• Design Requirements

Remember, design output should be design input. HDA tests the design requirements themselves by the output that they create. In addition, we maintain comprehensive design and process documentation to determine them quickly. 

• Design Process

Verification isn’t exclusive to any single level of development. Instead, we utilize verification processes to test and highlight issues within the design process itself. 

• Device Design

HDA tests to make sure that design outputs match the specifications of our design requirements. This determines if the product is on track and matches its predetermined specifications and functions.

HDA manages development and manufacturing with verification and validation processes to produce high-quality products. Both employ testing methods and standards but are performed at different stages in development.

Unlike our active verification process throughout development, validation is performed at the end. HDA leverages this dual system of testing to confirm the validity of the product and production process and guarantee the medical device is safe and effective for the user.

HDA Delivers Quality and Performance

We Simplify the Design Validation Process

All medical device products must go through validation before reaching the manufacturing process. Validation is a crucial component of the FDA certification process. Device development must consistently produce safe, effective products through design controls to meet FDA standards.

At HDA, design validation is a design controls procedure that functions as another safeguard to mitigate costly production mistakes and unsuccessful products. In addition, stringent testing measures are in place to demonstrate that the medical device functions as intended and performs as users expected it to.

Design validation is planned from the early stages of development to ensure that the end-user is always the priority during development. Validation confirms the medical device’s usability, efficacy, and safety before it heads to full-scale production.

We can produce small-batch production devices that simulate the conditions and production environment of the finished product. This is an essential detail when testing the product. We believe in removing variables and surprises by testing all processes, materials, and equipment in the development stage.

Medical device design controls help validate a product in several ways:

• Process Validation

Documenting development from design to manufacturing guarantees that the product will meet the intended specifications consistently.

• Design Validation

HDA has demonstrated over and over again that its products fulfill their intended functions and use.

HDA’s development process utilizes medical device design controls to optimize safety and production. Transparency in product development ensures that our products are helpful, non-harmful, and quickly approved in the regulatory process.

Start development on your innovative medical device design the right way. Reach out to HDA today and tell us about your revolutionary idea.

Start Your Project Today

Our Prototyping Brings Your Idea to Life

Because of our decades of experience and highly refined development process, HDA can meet your company’s needs at any stage in its development. Regardless of your unique goals, we can provide cost-effective solutions to get you there. For example, suppose you have already dedicated good design and engineering to your medical device. In that case, HDA can develop a proof of concept prototype that requires significantly less documentation than a market-ready product.

Let HDA Deliver Your Proof of Concept

Has your company identified an unfulfilled need in medical care? Have you developed an innovative product concept and need help testing the critical functions of your medical device design? HDA can test the efficacy of your idea with a proof of concept prototype.

Proof of concept prototyping offers several deliverables for your company:

• Verify Design Process. Prototyping your concept into a physical product allows us to determine whether or not the design process has achieved the intended specifications of the products. 
• Prove Functions. Similar to the verification process, prototyping makes it possible to test the functions of the products to make sure they meet the intended purposes of the design. 
• Draft Preliminary Test Methods. Prototyping allows testing the manufacturing methods and medical device design to produce an effective, consistent product.
• Design History Support. HDA provides an organized design history file that (DHF) documents your product’s design and development. We maintain DHFs for each device to make audits and inspections during the regulatory process as smooth as possible.

HDA has an extensive track record for delivering expertly-crafted prototypes and low-volume production builds to companies like yours. In addition, we can provide a cost-effective proof of concept prototype to kick off your product’s journey to the market. So get started today by telling us a little about your company and goals.

HDA’s Pre-Compliance Evaluation and Testing Saves Time and Money

Navigating the complex and intricate medical device regulatory process is not easy. Fortunately, HDA has an experienced, knowledgeable team dedicated to successfully seeing your product through the process.

HDA’s pre-compliance evaluation and testing streamlines the regulatory process and sets your product up for success. As a critical component of our product development process, pre-compliance assessment and testing ensure that you will pass certification quickly and confidently.

Benefits of Pre-Compliance Evaluation:

• Regulatory Compliance

HDA has decades of experience in the medical device industry. As a result, we understand what it takes to maintain an FDA-compliant development.

• Easy and Fast Certification

Setbacks in regulatory certifications can amount to significant delays and costly fines, possibly preventing your product from ever reaching the market. HDA mitigates certification hurdles by preparing your product for the necessary regulatory standards.

Benefits of Pre-Compliance Testing:

• Streamlined Development

We reduce the risk of lengthy delays and redesigns by testing your product’s critical functions against its intended use.

• Pre-Production Refinement

Our attentiveness to your product’s functions and use help reveal the most consistent and effective production methods. We can iron out any issues by refining the design and production process before stepping into the manufacturing stage.

HDA follows a proven process to get your medical device through development, regulatory certification, and manufacturing as efficiently as possible. Our approach is shaped by decades of experience in the medical device industry. 

Expert Medical Device Design Engineers Prepare Your Product for Manufacturing

HDA is dedicated to offering unparalleled quality and craftsmanship. We have on-site engineering support to help transform your innovative vision into a working product. In addition, our unique combination of size, experience, and wealth of resources allows us to carefully and confidently see each product through manufacturing.

Let’s Get Started

HDA is capable of manufacturing and delivering consistent, quality products that meet all necessary standards and regulations. Is your innovative medical device concept ready for production? Whether you need a limited run for clinical testing or high-volume manufacturing, HDA offers scalable options to help you achieve your production goals. 

We offer design, manufacturing, and support services to get your product into the marketplace. Our full-service development team utilizes robust manufacturing and quality management capabilities to scale expert craftsmanship and design to meet any goal. And, our in-house manufacturing floor can manufacture at any scale.

HDA presents a variety of resources and certifications that will benefit the development of your next medical device concept. In addition, our lean manufacturing process is a cost-effective solution that can deliver high-volume orders at consistent quality.

We engage in lean manufacturing to provide many benefits and advantages to our customers:

• Higher Efficiency

HDA focuses on minimizing waste within the manufacturing process while improving turnaround time and product quality. 

• Lower Production Costs

HDA saves you money by not wasting time, personnel hours, or raw materials on overproduction. 

• High-Volume Manufacturing

By reducing turnaround time through time management, more time is allotted for manufacturing your product. Additionally, the more efficient process allows manufacturing to begin and end without wasted strategies.

• Reliable and Consistent Quality

HDA is committed to providing the very best quality materials and manufacturing. Our investment in talented, expert personnel and well-performing equipment guarantees our level of quality throughout each project.

Our decades of experience have allowed us to refine our manufacturing strategies and processes. Trust HDA to manufacture your next medical device concept.

HDA is Your Medical Contract Manufacturing Company

HDA is a trusted product development partner for companies of all sizes. Our refined production processes and facilities are capable of scaling to meet high-volume manufacturing demands. We provide contract manufacturing solutions with the security of quality and cost-effective production.

Our contract manufacturing production feature essential processes and services:

• Device Design and Engineering Support

HDA has helped companies overcome logistical and technological challenges to produce their products as designed. We provide design and engineering solutions that optimize the performance of your device and streamline manufacturing and regulation processes.

• Quality Assurance

We understand the necessity for stringent quality assurance processes and protocols better than most throughout design, production, and manufacturing. Therefore, HDA adheres to strict quality standards to guarantee a safe, reliable product. 

Your project will be completed on time and within budget. HDA prioritizes thorough planning to mitigate unnecessary costs and delays throughout the development process. We operate a detail-focused development process because we know what’s at stake for your company.

• Post-Market Support and Service

Our job doesn’t end once your device makes it to market. HDA recognizes the importance of post-market monitoring and vigilance to guarantee patient safety and the future of your device. Therefore, we take a proactive approach to managing safety data to ensure the continued safety of your device.

• Calibration

Precision. Inaccurate device measurements and specifications can lead to unsafe devices, financial losses, and regulatory woes that slow down time to market. We perform instrument and device calibration to safeguard your device production against technical irregularities that may risk your device’s future.

• Purchasing and Bill of Materials (BOM)

We handle every aspect of production to offer a full-service experience for our customers. That includes procuring the raw materials necessary to complete the production of your medical device. Managing and purchasing BOM is unique for each device, so we make clear-defined material and manufacturing needs for your specific device.

HDA has experience developing and manufacturing devices with various medical applications as a leading medical device contract manufacturing company. Whether a consumer-use product or diagnostic equipment, we have tested and established production methods to efficiently and effectively manage the manufacturing process.

HDA can handle development, regulatory certification, and manufacturing for Class I, II, and III medical devices. Each class represents a device risk level; Class III is high-risk devices subject to the strictest regulatory standards. 

Our manufacturing capabilities can quickly scale to accommodate all medical device classifications and volumes. HDA’s state-of-the-art manufacturing solutions have produced successful devices that cover the spectrum of medical applications:

• Imaging and Diagnostics
• Surgical Equipment
• Radiofrequency (RF) Radiation
• Neurovascular Devices
• Airborne Emergency Oxygen Systems
• Spectrophotometry
• And more

Partner with HDA to leverage our experience and technological expertise in your groundbreaking medical device concept. We remain one of the leading medical contract manufacturing companies in Southern California because of our consistent, high-level production standards.

Work With Us

Compliant Pilot Production

We offer compliant clinical prototype production to fulfill low-volume, human-use devices for clinical testing and 510(k) premarket submissions to the FDA. Our production service is operated by industry-tested engineers, technicians, and support personnel with years of experience producing successful clinical prototype builds.

HDA combines engineering-based transfer to manufacturing and procedure-based assembly to ensure that every unit meets its intended specifications before leaving our facility. In addition, we utilize product-specific test processes that evaluate and verify that devices perform their critical functions. Our attention to detail helps customers meet their 510(k) submission standards, saving time and costly production fumbles.

Our cost-effective approach as a full-service medical device manufacturing company covers your medical device from concept to market. You must have confidence in our ability to develop, manufacture, and certify your product. As an ISO13485-compliant company, HDA values and prioritizes the quality and safety of its products. That’s why our personnel, standard, and experience reflect the values of an industry-leading medical device manufacturer. Additionally, HDA’s FDA and FDB certifications highlight our commitment to regulatory responsibility and quality assurance.

HDA Handles Post-Market Surveillance (PMS)

HDA’s goal is to continuously develop safe, effective products that benefit users and patients. We’re committed to ensuring that our devices remain safe and effective once they’re in their real-world environments. HDA manages PMS on each unique device.

We mitigate risk with stringent testing procedures and protocols throughout the development process. Additionally, HDA emphasizes its commitment to safe and functional products by maintaining a PMS system and reporting events to the relevant regulatory bodies. We track and report on all medical devices regardless of how it’s classified.

HDA utilizes a PMS system to address manufactured products in the real world:

• Detected and reported unintended outcomes involving our products
• Testing device functionality against real-world use
• Maintain device compliance with shifting regulatory requirements
• Ensure the safety and effectiveness of medical device products

As part of HDA’s after-sale support, we utilize reporting data to address and correct any unintended outcomes of our medical devices. We believe this proactive process is essential to delivering reliable, effective medical device products and ensuring the safety of consumers and patients that rely upon them.

Contact Us Today

Bring your new, innovative medical solution to one of Southern California’s long-time leading product development companies. HDA has experience working with companies of a wide variety of sizes, and our solutions scale to meet projects of any size.

Let’s get started! Reach out today for a consultation on your product development and manufacturing needs.

SERVICES

HDA provides contract manufacturing, prototype production, and compliant pilot production to the medical device and IVD industries. Our customers include medical startups, mid-size companies, and multinational corporations. We have developed refined development and manufacturing processes that can take your product through its complete lifecycle — from concept to delivery. HDA’s reputation for quality and reliability makes it one of the leading contract manufacturing companies in Southern California.

By combining the technical expertise of our full-service development team, we consistently deliver high-quality results to our valued customers. We have industry-best engineers, regulatory specialists, and development professionals ready to make your medical device a success. Our robust quality management system and decades of manufacturing experience guarantee reliable, functioning products. HDA approaches each project with a craftsman’s eye and dedication to providing excellence. 

There aren’t many manufacturers like HDA. Our blend of size, experience, and resources, allow us to scale quickly and responsibly to fit your company’s unique needs. You can be confident that every unit of your product will be well-built, reliable, and to your exact specifications. Production volume ranges from 5-50 compliant pilot units for clinical testing to hundreds or thousands of units per month for commercial production. We build durable medical equipment and disposables in our FDA-registered facility in Orange County, California.

Medical Device Contract Manufacturing Services

HDA is capable of handling your product’s manufacturing process from start to finish. From sourcing your entire Bill of Materials (BOM), developing the necessary manufacturing processes, and implementing required test systems, HDA Technology will deliver cost-effective and reliable results. Our lean manufacturing practices allow us to handle any order volume — ranging from low-volume to high-volume — to meet your production demands. 

We can quickly and efficiently optimize our large production facility to match your product’s production requirements. Our manufacturing facility is easily reconfigurable, allowing us to minimize lead time when starting production on your product. We prioritize lean manufacturing processes to our customers with reliable, cost-effective production services.

HDA’s lean manufacturing process offers many benefits to you:

• Cost-Effective Production. By sourcing only the necessary amount of raw materials, optimizing the manufacturing process, and reducing wasted efforts during production, HDA ensures you don’t get stuck with bloated manufacturing costs.
• Consistent Quality. Our full-service production team has the experience and expertise to make sure that your order is done right the first time. We have tried-and-true quality assurance and production procedures in place to guarantee high-quality products every time.
• Streamlined Manufacturing. We reduce lead times by eliminating unnecessary processes and slowdowns in production. Our efficient manufacturing methods eliminate wasteful and unnecessary processes during development. Our priority is to produce safe, functional products as quickly as possible.
• Large Scalability. HDA has the capacity to match your order size no matter the size. We provide fast turnaround on high-volume orders because of our efficient production practices. We’re able to comfortably scale to meet mass volume production goals while still accounting for quality and reliability.

Our full-service production process optimizes the manufacturing process to provide you with an easy, trouble-free experience. Are you looking for a medical device contract manufacturing company that provides specialized services? We specialize in a number of manufacturing and support services to meet any challenges your company may encounter.

Compliant Pilot Production

Are you in need of a cost-effective contract manufacturing solution to support your 510(k) filing or clinical testing? HDA specializes in Compliant Pilot Production to help your company get its product closer to the market. Our FDA-certified production facility produces fully compliant orders that will help you mitigate compliance delays and failures. 

Prototype Production

Prove your medical device’s critical function and design with a high-quality prototype. This essential stage in the development process evaluates the efficacy of your product before it goes to the mass manufacturing stage. HDA’s prototype production process saves time and money by testing your product before design mistakes complicate manufacturing. Our production facility is staffed by experienced engineers and technicians that can make your concept a reality.

No matter your needs, HDA can help your company achieve its goals. Our manufacturing and support services include:

• Purchasing and BOM Management
• Compliant Clinical Unit Production
• Prototype Production
• Volume Production
• Box Build
• System Build
• Disposables
• Optical
• Radio Frequency
• Calibration
• Test
• After-sale Support and Service

RESOURCES

As a full-service medical product development and manufacturing company with decades in operation, HDA has developed an extensive amount of resources to aid the development of your unique product. Leverage our resources and knowledge to properly and efficiently manufacture your innovative medical device concept.

HDA has the resources and certifications to help you:

• Large, open manufacturing floor
• Lean Manufacturing Process
• ISO 8 Cleanroom
• Thermal Test Chamber
• Easily Reconfigurable Facility
• Climate Controlled, ESD-Safe
• FDA- and FDB-registered
• ISO-13485 Certified
• Decades of experience

FDA AND FDB REGISTERED

ISO CERTIFIED QUALITY MANAGEMENT SYSTEM

Our robust quality system allows us to provide you with world-class products throughout their life cycle. This means better designs, complete documentation and safe, effective and reliable products in the field.

We believe that our commitment to quality is crucial to your success, and continue to invest in our people and quality management system (QMS) to ensure that we deliver the best value to our clients by using well-established development, production and documentation methods.

HDA is certified to ISO 13485 for the design and manufacture of medical devices, and registered with the FDA and California FDB to manufacture medical devices.