Medical device development is a multi-step process. Proving that your preliminary concept is possible is a critically important phase in bringing your new medical device from idea to reality. 

The word “prototype” is almost ubiquitous these days, and used across many different industries, but it can mean very specific and different things depending on your goals and your product. HDA Technology’s approach to prototyping is integrated into our product development approach and focused on feasibility. We wanted to use this article as an opportunity to unpack everything you can and should expect in the prototyping phase of your medical device manufacturing journey.

What is Medical Device Prototyping?

A prototype can be defined as the preliminary or original example of an idea, concept, or plan that has not yet reached fruition. The word can be broken in two – proto meaning “the first of” and type referring to the item or idea. 

Prototypes can have many different uses. They can validate an idea or test a theory, clarify the requirements for designing or manufacturing something, prompt feedback from stakeholders and investors, and be used for evaluation of function and identification of design flaws. Prototyping refers to the process or phase of prototype creation and testing. In medical device development, there are a few different ways that prototyping can happen. 

First, prototyping can be seamlessly integrated into your full development process. That is to say, as an organic part of the design phase of medical device development and manufacturing, a prototype is created to test for the feasibility of functionality,  production, safety and certification issues, closeness to the original vision, and, ultimately, manufacturability. Second, prototyping can be a service or independent phase offered. Prototyping services imply selling 3D printed mock-ups, rapid turn manufacturing, and physical prototyping.

As is the case with all development and manufacturing firms, HDA engages with prototyping in the former way: it is an organic part of our process. We focus on proof of concepts, which are chiefly concerned with the feasibility and manufacturability of your product. 

Types of Prototypes

Prototypes can range from low-fidelity to high-fidelity and can be categorized in a number of different ways depending on what production needs you are prioritizing. HDA Technology generates proof of concepts when appropriate, and also builds full functioning prototypes on the way to pilot production. A range of prototypes that can be relevant to you depending on your product goals. 

Proof of Concept (Low Fidelity)

A proof of concept (PoC) is meant to offer a basic representation of your device’s shape or functionality. It’s cost effective and often used to demonstrate and evaluate the feasibility of manufacturing your product for your stakeholders or investors.

Full-Functioning Prototypes (Mid Fidelity)

A full-functioning prototype mimics the detailed functionality of your device – how it operates and in different conditions. You can use full-functioning prototypes to test your device’s performance and consumer or buyer usability. While a PoC is not really meant to be used in the “real world”, full-functioning prototypes can be applied to different situations to gauge the device’s realistic performance. 

Product Equivalent Prototypes (High Fidelity)

Product-equivalent prototypes are the last phase of prototype creation. This type captures all the features of your final product, including design, user features, and function. This is the closest thing you will have to your final product and is used for final rounds of testing. Product-equivalent prototypes are used when you are transitioning from small-volume production to mass- or large-volume production.

Prototypes can be further typified into categories like feasibility prototypes, sketches, and diagrams (abstract representation of the final product), rapid models (prototypes focused on the form and fit of the device), and working models (prototypes focused on the function of the product).

Medical Device Prototype Development: Steps for a Proof of Concept

As discussed, a PoC is a preliminary way to demonstrate that your device idea, new technology, or novel design improvement has the potential for real-world application. The idea of a PoC is simple. As the originator of your new idea, it may be easy for you to understand or envision how it’s going to work. 

But when you come to explain it to others – whether it be your investors, business partners, or manufacturers – their eyes glaze over. If you can simplify your idea, ideally with a visual aid or demonstration, you are now able to communicate your vision directly and practically. This opens up opportunities not only for feedback from others but for reflection and refinement of your idea on your part as well. As applied to potential investors, a PoC may also lead to additional funding!

PoC development is an integrated part of HDA’s workflow and happens early in the development process. A PoC can help validate the basic concept of your device, forecast how much manufacturing will cost, verify the expected results of your product, identify risks associated with your product, and facilitate feedback from stakeholders and investors. PoC can also be valuable in research and development contexts, where a novel technology must be tested before a medical device is designed around it.

It’s always important to remember that the form of your PoC changes depending on your priority needs. 

Validating the Basic Concept of A Device

You may already have a clear picture of what medical device you want to develop, but not a lot of confidence that your vision of this device will work. HDA will mock up what is called a PoC Demo. To do this, we could use commercial off-the-shelf (COTS) components, various lab equipment, and crude fixturing to create the effect that you are hoping to achieve with your final device. This product will not be fully functional – it will be a concrete, physical device that the client will be able to see and engage with to clarify their vision. This will also help us refine our approach to the product’s development and manufacturing. 

Facilitate Feedback from Stakeholders and Investors

In a different case, you may be a startup needing to prove to potential investors that your vision for your device’s function is possible. As a result, the PoC we develop will not need to look pretty or even accurate to its final form, but rather needs a degree of functionality; design and fabrication will be tailored to achieve minimal, non-clinical function without committing to the full scope of the device’s design and appearance. 

One of our clients once secured a major investment by verbally describing what they wanted to build to investors while showing them a block of wood with a hole drilled in it, a crank made out of a pencil, and some fishing line. The resulting startup was very successful.

Further Research and Development

PoC development is also a good fit for research and development efforts, where the method by which to achieve a novel medical procedure is being tested. An example of HDA’s experience with this kind of PoC is our work with a very high-performance special purpose electro-cautery system. We were tasked with developing new technology for a novel tissue-cutting application. 

This was a PoC focused on approach and method; the design of the medical device wasn’t important! Only after we developed a functional mockup of the trial technology was the development of a medical device greenlit. 

HDA makes it a priority to support you if your investors need to discuss the device’s technical specifications with us at this PoC stage. 

From Prototyping to Regulatory Approval

HDA prides itself on embedding high-quality and regulatory standards into its process and ethos as a company. That being said, our prototyping work is primarily focused on PoC; because PoC are not human-use devices, FDA regulations are not a significant concern at this stage of the medical device manufacturing process. Furthermore, when developing a PoC, our focus is to figure out how to accomplish a functional goal, or how to illustrate your vision of the product. At this stage, regulatory compliance would add considerable cost and time that may be redundant if the PoC demonstrates that an idea is unfeasible or must be altered. As a result, designing for regulatory compliance becomes practical after the PoC phase, and moving into pilot production. 

Every new idea needs to be tested before it’s manufactured. HDA Technology conducts proof of concept testing for all of our clients as a natural part of our high-quality development and manufacturing work. If you have additional questions about what HDA’s prototyping process looks like, or would like to request a consultation, you are invited to get in touch.

How can we best expect the unexpected? In medical device contract manufacturing, there will always be roadblocks to getting your product to market safely and successfully. One way to avoid downstream pitfalls is to build your process — and device — with manufacturing in mind.

In this article, we’ll take you through the ins and outs of HDA Technology’s design for manufacturability approach: a design philosophy that encourages the design, development, and manufacturing of products that have high producibility, low cost, and long endurance.  

What is Design for Manufacturability?

Design for manufacturability (DFM) refers to a design methodology embedded throughout a company’s manufacturing system. Implementing DFM yields two-pronged results: 

• Strategically anticipate manufacturing needs early in the design process.
• Proactively design your product to meet those needs.

Through this dual output, DFM ensures that your product achieves ideal cost, quality, reliability, regulatory compliance, time to market, and customer satisfaction.

A core tenet of DFM is the simplification of production. This does not mean sacrificing quality – quite the opposite! Under DFM principles, the more “producible” a product is, the more likely it is to be manufactured at a higher level of quality, consistency, and reliability. 

To achieve greater producibility, the design process focuses on simplifying your product to its more necessary elements and analyzing each component against the question, “What is the ‘best’ way to manufacture this?”. Depending on the industry and process technologies involved, DFM analysis might focus on improving process yields, fabrication, assembly, product testing, or packaging.

A Whole-System Approach to Medical Device Manufacturing

In medical device development and manufacturing, the FDA defines 5 phases of development for a medical device: design inputs, design, verification, validation, and transfer to manufacturing.  

Design inputs are when your team generates the definition of what the product is supposed to be. This includes deciding on specifications and requirements and refining your end vision for the product.

Design refers to the part of the project where you design the device, build prototypes, and ensure it all works before you commit to manufacturing. 

Verification is the phase in which you verify or evaluate whether the outputs of your design phase meet the specifications of your vision.

Validation involves testing your device to ensure it meets industry safety and certification requirements and that it performs its intended function (determined at the design inputs phase) properly and efficaciously.

Finally, transfer to manufacturing is the phase in which you set up the manufacturing processes themselves and validate them. At this point, your product is ready to be manufactured.

The earlier and more systemically embedded your DFM principles are adopted, the more likely it is that your device will succeed. By success, we mean: made under/meeting budgeted manufacturing costs; high quality; reliable; assembled parsimoniously; and, finally, meet all regulatory and performance requirements.

DFM is not just relevant to the whole manufacturing system in a technical sense: it has a human dimension, too. Successfully implemented DFM demands contribution, collaboration, and an integrated, forward-looking mindset from people at all levels of the manufacturing process. 

That’s not to say timing doesn’t matter at all for DFM. In the linear production timeline, DFM is most important to the design phase of medical device manufacturing. 

While in name DFM is tied to the design phase, strategies for implementing DFM engage with all stages of the D & M process. This includes culture, suppliers, finances, and timelines. Integrating multiple parts of your development process into one coherent system of development, design, and manufacturing is both important for and an outcome of DFM. 

From Design to Manufacturing 

The design input and design phases are where your product vision is tailored to meet your customer’s requirements. It’s after these two phases that you verify and validate your product for real-world settings. Having completed an initial opportunity and risk analysis and created a proof of concept (concerned chiefly with feasibility) for your product idea, we use this time to test the product against your original vision and industry safety and certification requirements. This is when you and your contract manufacturer will think hardest about your product’s manufacturability. 

DFM considerations need to be incorporated at around the middle or toward the end of the design phase when functionality has been realized and refinement of the design is in process. A design phase that centers around DFM ensures the design of a product that is safe, reliable, and high quality. This phase is thus especially important for medical devices, which are used in high-stakes situations and require a very high level of quality, reliability, and consistency of production.

How Do We Implement DFM?

Strategies for practically implementing DFM can be many. Some ways HDA adopts the DFM approach include: 

1. Defining the product as clearly and methodically as possible. We work closely with you to ensure we’ve taken your needs into account from the start.

2. Ensuring the resources needed for your product are available early in the development process.

3. Creating a realistic timeline. Because HDA is also a development company, we ensure adequate attention is given to the development and design phases of product development.

4. Taking a collaborative and communicative approach, we bridge gaps between people and phases in the development and manufacturing process to account for needs and perspectives at all points in the process.

5. Regularly evaluating our progress, reflecting, and learning from feedback and past experience. We apply tools like the PDSA cycle to evaluate our work as we go.

6. Designing your product with existing manufacturing processes in mind. As a company using lean manufacturing principles, we avoid the superfluous need for new manufacturing processes that may reinvent the wheel.

7. Sourcing our materials from proven, trustworthy sources and vendors with reliable delivery times. 

The Five Dimensions of a DFM Approach

The implementation of a DFM approach can be summarized as 5 interrelated dimensions.

Design refers to the development of product features according to 1) principles of good manufacturing and 2) whatever need the product is fulfilling.

As a medical device developer and manufacturer, HDA designs everything we manufacture for our clients. As a result, we have a deep technical knowledge of the products that we build and can support the process of manufacturing them more effectively and efficiently than if we were not involved the whole way through. 

Materials focus on the type, makeup, quality, suitability, cost, and source of materials used to manufacture your product.

Here at HDA, all of our product materials are sourced from suppliers who pass our vendor approval process – a process defined by our ISO 13485 Certified Quality Management System. While some product components are only available in Europe and Asia, we aim to source as much as we are able from domestic suppliers to ensure the quality and transparency of the material’s makeup.

Process refers to the method and/or steps we use to assemble your product.

HDA Technology employs a collaborative process for manufacturing that leverages the input and capacity of the whole system. For example, we seek input from our manufacturing group during the design process to ensure that products are efficient to build and maximally reliable. This ensures a direct line of communication between the need, the design, and the final product.

Performance takes into consideration whether the product will perform as desired in “real world” situations.

Prototyping and verification testing are an integral part of HDA’s development process. We build development platforms that contain the necessary and representative components of your designed product, and in so doing can thoroughly test and verify the product’s “real world” useability before launch.

Regulations refer to any industry standards with which the product must comply to be marketable.

HDA is both ISO 13485 certified and FDA and FDB registered. This ensures that industry standards are embedded into our design process. All design and manufacturing considerations or decisions are made through the analysis of these industry standards. Through this, we embody the future-facing attitude that DFM demands. 

DFM and Medical Devices: Designing for Safety and Reliability

Here at HDA Technology, we understand that the need for high reliability and repeatability is crucial to medical device manufacturing. Field failures, or the release of a product that is not functioning to specification, is not acceptable. 

By using a medical device product manufacturer that has implemented DFM into their process, you ensure that your medical devices will be easily manufactured within your manufacturing cost target while also being compliant with regulatory requirements and performance/quality standards. 

The Rule of Parsimony: Simpler is Better

Medical devices can sometimes be intricate or complicated to make. A manufacturer that has implemented DFM can reduce complexity as much as possible and pare the product’s design down to its most essential needs.

DFM Now, Time and Money Saved Later

DFM saves time, reduces the number of steps in production, and ultimately reduces the risk of error, which is critical for medical device production.

DFM also reduces accumulated costs down the line. While durability is a DFM consideration that may be costly up-front, the future-minded manufacturer understands how product durability will save money in the long run.

Restrictions, Regulations, and Recalls

Because medical devices are so highly regulated, post or end-of-production recalls, changes, and revisions are expensive and disruptive. DFM reduces the likelihood of revision later in production. 

Managing Mass Production

Some medical devices need to be made at very high volume. Using DFM puts in place safeguards against the lure of producing products at “sufficient” or baseline quality, as much of the quality assurance work is done early in the design process. 

As production volume increases the impact of DFM on production capacity becomes more apparent: the more you factor production efficiency into the design, the more devices you can build in a given period and allocation of space.

In working with a medical device contract developer and manufacturer like HDA Technology, you are secure in the knowledge that every device you produce will benefit from our systemic DFM approach. 

If you have additional questions about how HDA has implemented Design for Manufacturability or would like to request a consultation, you are invited to get in touch.

Excellence in product does not have to mean excess in production; the right manufacturing philosophy will address need, maintain sustainability, and deliver quality – all while streamlining medical device production. The ability to nimbly navigate new research and arising needs without falling into the trap of overproduction can set a California medical device contract manufacturer apart.

Lean manufacturing principles are one key way of minimizing waste while maximizing quality in medical device production. We’ve built this article as an exploration of lean manufacturing principles, and an introduction to how HDA Technology implements them in our process.  

What is Lean Manufacturing?

Lean is a production ideology that originated pre-World War 2 in the sphere of motor manufacturing. Lean manufacturing ideology is oriented around the goal of maximizing productivity while simultaneously minimizing waste within a manufacturing operation. Put succinctly, lean means “a way to do more with less”. The core principle of lean is that eliminating waste is a means of continuous improvement.

Waste: The Enemy of Lean

Waste, otherwise called muda in lean ideology, is defined as anything that does not generate value for the customer. Value, in turn, is defined by the customer: in lean ideology, value is defined as anything the customer believes they need, and is consequently willing to pay for. As a result, waste becomes anything that requires resources for which the customer is unwilling to pay.

Examples of waste according to lean ideology include overproduction, wait times between steps in production, unnecessary transportation time, overprocessing, excess inventory, product defects, and underutilized talent. The primary aim of a lean approach to manufacturing is the reduction of waste.

The Goals and Benefits of Lean Manufacturing

Lean ideology aims to generate sustainability in production processes and create high-quality products and services. A contract manufacturer that has implemented lean principles effectively can eliminate waste, improve product quality, reduce costs, and reduce overall lead time.

A Lean Approach to Medical Devices

Lean principles, applied to medical device development and manufacturing, can positively impact medical device production by reducing time to market and improving quality. Together, these outcomes also serve to improve profitability – something every manufacturer wants.

At HDA Technology, we understand that medical device design and manufacturing, by its nature, necessitates quality elements such as proven design, proper component and vendor selection, competent and appropriate manufacturing and test processes, and a very high level of quality. Like in the case of ISO certification, the adoption of lean principles embeds a quality improvement methodology into our process that enables a streamlined realization of these elements.

Reducing Time to Market

In the world of medical device production, the need you are aiming to meet can be urgent. Time to market may be uniquely important to medical device development and manufacturing in the case of novel devices used for potentially life-saving procedures. Case studies show that integration of lean principles into manufacturing processes can significantly reduce time to market for medical device production – without sacrificing the quality or reliability of the product.

Achieving a High Level of Quality 

We know from experience that medical device development and manufacturing requires a high level of quality control. It also needs a corresponding process that meticulously documents that quality control. Inherent to the implementation of lean principles is meticulously documented quality improvement and control – we’ll talk more about this soon.

At HDA Technology, we leverage lean manufacturing principles to ensure that our products are highly effective, meet product and regulatory requirements, and are manufactured with tight turnaround.

5 Core Principles of Lean Manufacturing

Lean manufacturing ideology can be defined through 5 core principles: 

Value

Value under lean theory is determined by the customer’s need and/or circumstance. It depends on how much and for what the customer is willing to pay.

At HDA Technology, we strive to meet our clients’ needs. Part of HDA’s role as a medical device manufacturer operating in the medium to low-volume space is working with our clients to develop products that actively meet their customer’s needs. Our ability to operate efficiently and our willingness to listen helps HDA Technology deliver good value to our clients in more ways than one.

Value Mapping

In lean lingo, an ongoing priority is understanding the life cycle of your product. Value mapping is a lean principle referring to the analysis of production with a triple aim: 1) identifying waste 2) reducing it in the moment, and 3) problem-solving for improvement in the future. The work streams that make up a product lifecycle are often complex, so to effectively value map, you need to include nonlinear processes and multi-disciplinary employee perspectives and expertise in your map.

At HDA Technology, we conduct value mapping during purchasing, production and assembly, and test and service. This state of constant, positive scrutiny helps us improve the total cost of goods,  reduce the risk of negative impact on yields and quality, and improve the timing and repeatability of production cycles.  

Flow

Tired of constant interruptions to medical device production? In lean manufacturing, flow means ensuring a process is continuously worked on without interruptions of fragmentation until fully complete. To achieve flow, a contract manufacturer can remove barriers to the process – for example, removing the use of batching and queuing, where each step entails waiting and fragmenting of the process.

HDA implements the principle of flow in how we structure our production: on a per-product basis, our total product production costs are broken down into fine increments, are well understood, and are frequently analyzed to capture improvements in cost, yield, or final quality.

Pull

A company uses a pull approach when they perform work and manufacture a product according to consumer demand. In contrast, a push approach is when a company manufactures a product even when there is no demand. 

When implementing a workstream, a push approach can result in manufacturing steps being performed out of order. On the other hand, embedding the lean principle of pull within a company ensures that the next step in a given workstream is only performed when it is needed, or when the system is ready for it. This helps to streamline the manufacturing process and reduce waste.

At HDA Technology, we use the pull principle in 100% of our production. We keep in close contact with our customers, review their current and future forecasts for production orders, and synchronize our raw material orders and production planning with their desired ship dates. Using a pull allows us to meticulously plan our workstream to balance your need for materials with unstable delivery forecasts against elements of the production plan with a short lead time.

Perfection

The principle of perfection represents a key tenet of lean: no matter how many times a process is improved, it can be further enhanced. 

To implement this principle, manufacturers can use quality improvement cycles like plan-do-study-act, or PDSA, in their process. Perfection methods like PDSA are a scientific approach to evaluating, recommending, and then evaluating whether that recommendation has the desired impact – namely, reducing waste and improving quality. Any desired improvements are then integrated into the system and the cycle is renewed.

Naturally, HDA’s goal is perfection, and we take deliberate steps to achieve this goal. DA’s goal is perfection, and we take deliberate steps to realize this goal. HDA Technology is both an ISO and FDA-registered company – evidence that we take our quality and production efficiency seriously. Guided by the principle of perfection, we evaluate our processes regularly and systematically to achieve outstanding quality and optimization of process.  

Strategies for Implementing Lean Manufacturing Principles

To integrate lean methods into their process effectively, medical device manufacturers must account for the complexity of their production system. This means thinking about the behaviors and needs of active agents in the system, like employees, clients, or other stakeholders.

Different strategies exist for practically implementing lean manufacturing principles into your company’s process while also considering system complexity. Two key example strategies include 5S Implementation and the Kaizen Program.

5S Implementation

5S Implementation is a 5-step process for practically implementing lean principles into your production system. 5S stands for:

Sorting

Get rid of items in a process that you don’t need. To sort is to declutter your workstream. For example, you may be ordering materials for a feature in your medical device that does not actually address a consumer need; removing this will reduce waste and result in a more focused product.

Setting in Order

Provide the tools, materials, or space needed to do the work. Medical device production can involve a lot of precision and the use of potentially delicate tools and materials; the more organized the space, the more effective and efficient the work.

Shining

To shine is to refine. An advanced form of decluttering, this step makes sure that you have fine-tuned your work stream and eliminated untested steps that could cause potential product defects or issues to emerge later on. This is especially important in the production of medical devices because product defects down the line could be the difference between life and death.  

Standardizing 

It’s time to standardize your newly-refined best practices. By standardizing, you are giving different agents in your workstream the shared responsibility of maintaining the new process. Medical devices must be reliable, high quality, and consistent – the standardization of best practices ensures this.

Sustaining

This is the maintenance phase. You have set your workstream, and the agents within it, up for success. Moving forward, your team can provide and review peer-to-peer and internal feedback regularly; because of your hard work early on, acting on the feedback should be simpler and painless. This regular and sustained feedback process ensures consistent quality in medical device production. 

The Kaizen Program

Making big changes to your process without collaborating and communicating with employees can be counterproductive. One way of preparing for this is training employees in lean principles and promoting a lean culture throughout the company system. Alongside 5S, contract manufacturers can use the Kaizen Program to engage stakeholders in the improvement of their production system.

Kaizen is one strategy for implementing lean principles while taking into account employee/human feedback in the process. Kaizen is essentially a form of formalized PDSA cycle – the process we discussed under the principle of perfection – but focused on feedback from a contract manufacturer’s employees. Using Kaizen can reinforce the lean principle of perfection in all aspects of your medical device production.

Where is HDA Technology in its Lean Journey?

As a medical device contract manufacturer in California with a commitment to both high- and low-volume production, HDA Technology strives to embed quality improvement methodology into every aspect of our work. Lean principles are both systematically and organically part of all projects we work on with you. 

HDA is advanced in its implementation of lean principles and has been on its lean journey for years. We are currently focusing on refining approaches to manufacturing that pair well with lean ideology. A good example of this is design for manufacturability – the testing, packaging, and service that takes place during the design phase early in medical device development. 

Another good example is our focus on reliable procurement: we want to have second and third sources for all materials, to be sure that materials are made properly and have a known pedigree, and to know that materials arrive when expected. 

Medical device manufacturing relies on reliability, precision, and a commitment to quality improvement. HDA’s lean approach to manufacturing brings all of this to the table and more. 

If you have any additional questions about HDA’s manufacturing and production approach, you are invited to get in touch.

Among medical device contract developers and manufacturers, no two companies are alike. One key differentiator is their level of adherence to standards and certification. Understanding why a contract manufacturer has established certain management procedures and how they are enforced will help you decide whether they are the right fit for your purposes. ISO 13485 is a critical certification, so we’re starting there and discussing its key role in medical device development. 

We’ve also built this article as an overall primer to introduce you to HDA Technology, our certified quality system, and its many benefits and attributes.

Why Do Standards and Certifications Matter?

Precision, risk management, and reliability are paramount in medical device manufacturing. We have decades of experience to prove it. 

A company’s quality system defines the effectiveness and consistency of its internal processes. A good quality system can define a company’s development, manufacturing, and product lifecycle management procedures. In the medical world, where manufactured products are used to diagnose, treat, and improve quality of life, this definition becomes critical for ensuring the highest level of safety possible. 

As a medical device contract manufacturer operating in low and mid-volume spaces, we understand the critical role that standards and certifications play in every sphere of the industry. At HDA, our willingness to take on smaller clients also comes along with a customer and product focus that is quality-driven rather than cost or throughput-driven.

Patient Safety is Non-Negotiable

The stakes are always high for medical device development, regulatory work, and manufacturing. There’s a direct line between the quality of devices, the success of procedures, and the health and well-being of patients. We know our clients want to prioritize positive patient outcomes.

Adherence to standards and the certification process serves to safeguard against potential hazards. Standards establish clear guidelines for product design, manufacturing processes, and quality control, ensuring that every medical device meets predefined safety standards. Compliance with these standards is not optional; it’s a moral, ethical, and legal obligation.

Consistency and Reliability

The medical industry relies on consistency and reliability. Patients, physicians, and healthcare institutions need to trust that a device will perform as expected every time it’s used. Standards and certifications create a framework for consistency with these electronic devices by defining specific requirements for materials, manufacturing processes, and quality control. This consistency manages risk, builds trust among stakeholders, and ensures that medical devices maintain their effectiveness throughout their lifecycle.

HDA Technology specializes in electronic equipment, both durable and capital; our adherence to standards ensures a consistently high level of quality in every device we work on. With us, you know exactly what to expect, and you know it’s good. 

Regulatory Compliance

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent requirements for medical devices. Manufacturers must navigate complex regulatory pathways in this country — as in all others — to bring their products to market. 

Standards and certifications align with these regulatory requirements, making the approval process smoother and faster. They act as a roadmap, guiding manufacturers through the necessary steps to meet compliance, and reducing the risk of costly delays or product recalls. 

Our company works with both U.S.-based businesses and startups as well as internationally-oriented clients, and we are committed to following this roadmap.

What Is ISO 13485?

ISO 13485 is an internationally recognized quality management system standard designed specifically for medical device manufacturers. It is derived from ISO 9001, which is used in many industries as a gold standard. You may encounter development and manufacturing companies that proudly claim ISO 9001 certification, but are without ISO 13485. The latter standard specifically outlines the requirements for a comprehensive quality management system tailored to the unique needs of the medical device industry. As a result, while being ISO 13485 certified guarantees ISO 9001 certification too, the inverse is simply not the case.   

ISO 13485 is, at its core, a quality improvement methodology: it forces developers and manufacturers to do high-quality work from the get-go and to improve systematically from there. Compliance with ISO 13485 signifies a commitment to ensuring the safety and effectiveness of medical devices, which is of paramount importance in healthcare.

ISO 13485 for Low-Volume Electronic Medical Device Manufacturers

At HDA Technology, we pride ourselves on working not only in high-volume production but also with startup and early-stage companies in the low-volume sphere. While ISO 13485 applies to all medical device manufacturers, it holds particular relevance for companies specializing in low-volume electronic medical equipment like HDA. Here’s why:

Regulatory Alignment

Simplified Regulatory Compliance: ISO 13485 harmonizes with various international regulatory frameworks, including the U.S. Food and Drug Administration (FDA). Development and manufacturing companies like HDA Technology work regularly in the international market. 

This harmony simplifies the regulatory compliance process – first, for low-volume clients interested in an international market, and second, for low-volume clients who are undecided when they begin their work, but may later want to expand.

Quality-Focused Culture

Commitment to Excellence: ISO 13485 integrates a culture of continuous improvement into your company’s work. In low-volume manufacturing, every device counts, and quality is non-negotiable. Adhering to ISO 13485 builds an environment where every aspect of the development and manufacturing process is methodically scrutinized and optimized for quality, even for low-volume production runs.

Risk Reduction

Proactive Risk Management: In low-volume electronic medical equipment manufacturing, errors can be costly for your finances and reputation. ISO 13485’s emphasis on risk reduction and management helps manufacturers identify potential issues early in the development process, reducing the likelihood of unnoticed defects and costly recalls.

Documentation and Traceability

A Keen Eye for Details: ISO 13485 mandates comprehensive documentation of all processes, from design to production. In low-volume manufacturing, where product knowledge may be concentrated in a few experts, this documentation ensures that vital information is retained and can be transferred seamlessly from one phase of production to the next.

Supply Chain Control

Ensuring Supplier Reliability: For low-volume manufacturers, maintaining control over suppliers and ensuring their compliance with quality requirements is crucial to maintaining consistent product quality. ISO 13485 emphasizes the importance of using qualified suppliers and monitoring their continued performance, which reduces the risk of supply chain-related roadblocks. 

Enhanced Customer Trust

Confidence in Product Quality: Healthcare professionals and institutions rely on medical devices for patient care. ISO 13485 certification provides assurance that the devices are produced in a controlled and quality-focused environment, enhancing customer trust and confidence in your products.

Scalability

Preparedness for Growth: Low-volume manufacturers often aspire to scale up as product demand increases. ISO 13485 provides a solid foundation for growth by maintaining unshakeable quality standards which help companies transition smoothly from design into production.

Global Market Access

International Acceptance and Opportunity: The medical device industry is global, and manufacturers often aim to reach international markets. Devices that meet internationally recognized standards can be more likely to gain acceptance in various markets, making it easier for manufacturers to expand their reach and serve a broader customer base.

Because we work with both U.S.-based businesses as well as internationally-oriented clients, we know that standards and certifications help to bridge the gap between different countries’ regulatory requirements. We want our clients to have every opportunity to widen their reach, and our adherence to these standards makes it all that much easier.

Competitive Advantage

Stand-Out Quality and Reliability: In a crowded marketplace, standing out is essential. Achieving and maintaining standards and certifications can give a manufacturer a significant competitive advantage. It demonstrates a commitment to quality, safety, and continuous improvement, which can resonate with customers and partners. 

By being certified, HDA Technology shows your customers the quality and reliability of your products – giving your product a competitive edge, and you the ability to stand out in both local and international markets.

Risk Management and Reduction

No More Costly Recalls: Errors, defects, and recalls can be costly – both financially and reputationally. Standards and certifications serve as proactive risk reduction tools. By following established guidelines and best practices, we manufacturers reduce the likelihood of production errors and defects. Moreover, adhering to these standards can help identify and address potential issues during the design and development phases, preventing costly recalls and protecting the brand’s reputation.

The combination of our certification and our breadth of experience smooths out your path to market significantly.

Innovation and Advancement

Open the Door to the Future: Standards and certifications are not static; they evolve in response to advancements in technology, changes in regulations, and emerging safety concerns. 

By complying with these standards, HDA both contributes to and participates in the industry’s ongoing innovation and advancement. We play a small part in helping to shape the future of medical device technology while ensuring that it remains safe and effective.

Confidence for Healthcare Providers

Ensuring Provider Safety: Healthcare providers are on the front lines of patient care and safety. They rely on medical devices to make critical decisions and provide the best possible treatment. When healthcare providers know that a medical device is certified and meets established standards, they can have confidence in its performance. This confidence is not only essential for delivering high-quality healthcare and ensuring positive patient outcomes – it also keeps providers safe from the physical, emotional, and legal risks of unreliable devices. 

We know that the relationship between providers’ confidence and security and patients’ outcomes and safety is iterative. Our goal is to ensure both, as consistently as possible.

Long-Term Cost Savings

Strategically Avoid Unexpected Costs: Investing in standards and certifications may require up-front time and resources, but it pays off in the long run. By adhering to these standards, manufacturers reduce the likelihood of costly product recalls, legal liabilities, and reputational damage. Additionally, a commitment to quality can lead to improved operational efficiency and reduced waste, resulting in cost savings over time. 

While the opposite may at first appear to be true, we have the experience to back us up. We often meet clients who have found out the hard way that adherence to standards and certifications is a major cost-saver.

Ethical Responsibility

Prioritize Harm Reduction: Manufacturers have an ethical responsibility to prioritize patient safety and well-being. Standards and certifications provide a clear path for fulfilling this responsibility. By adhering to these standards, manufacturers can demonstrate their dedication to producing devices that not only meet regulatory requirements but also contribute to improving healthcare outcomes for patients worldwide. 

At HDA Technology, we demonstrate this dedication in every single step of our process. 

To summarize, standards and certifications are a key backbone of the medical device manufacturing industry. They ensure patient safety, drive consistency and reliability, facilitate regulatory compliance, and offer numerous benefits to manufacturers and users alike. At HDA Technology, we are committed to adhering to the highest industry standards and certifications to produce safe and reliable medical devices that contribute to a healthier world. 

The ISO 13485 Medical Devices Quality Management System

We’ve discussed standards and certifications from a general perspective and jumped into context on 1SO 13485. Let’s touch base again on the key ways in which HDA’s adherence to ISO 13485 differentiates us from competitors and benefits our clients. As a reminder, ISO 13485 is the primary controlling quality standard used in the medical industry, while AS9100 is the top-level standard used in aerospace. ISO 9001 is used in many industries and is the quality system from which both ISO 13485 and AS9100 are derived.

ISO 13485 Saves You Money

Working with a development firm with a certified quality system saves time and reduces costs.

No matter how good a job you think you are doing, there will almost always be something that doesn’t quite meet the exacting quality of regulatory standards. The only way to know for sure whether your work meets the standard is to conduct regular audits throughout the development and manufacturing process. A certified company like HDA Technology has these regular check-ins embedded into every step of our process. With us, you will never have to worry that your final product won’t be up to snuff.  

Many design firms claim that by not becoming ISO certified they will save you money. Their usual rationale is that they are compliant on their own so you will get the benefits without the cost. 

In reality, the cost of certification is a very small part of a typical firm’s overhead, and the resulting improvements to the development process serve to reduce development costs and reduce program risk. The only way for a quality system to be compliant is through verification with regular audits – audits that ISO 13485 certification builds seamlessly into your system.

The Quality Assurance System You Need

In an ISO 13485 environment, like the one we have at HDA Technology, the goal of the system is to achieve continual improvement in effectiveness, quality, reliability, and yield. At HDA, certification is just as important for shaping design activities as it is for guiding manufacturing processes. The purpose of a quality system during product development is to ensure that products are designed using procedures and processes that enforce thorough and effective planning and risk mitigation methodologies. 

This serves two important purposes: it ensures that all necessary features are designed into the product from the beginning, and it prevents the unnoticed inclusion of deficiencies. 

Consider a situation in which a deficiency is discovered during a later testing phase, or worse yet, when volume production has been released into the field. These problems, when found late in the process, can be costly to correct. Likewise, an important product feature or requirement that is omitted from a design during development is much more costly, if not impossible, to implement later in the program. 

During manufacturing and throughout the product lifecycle, a properly executed quality system ensures that every product built will meet customer and regulatory requirements. When problems are discovered in a finished product, the quality system provides a process for identifying the defect, determining its root cause, and implementing the corrective action to be taken so that the problem does not recur. 

External Checks and Balances

Because our company is ISO 13485 certified, we are audited regularly by internal auditors and by external registrar auditors. This ensures that 1) we, alongside all other certified companies, are following our quality system faithfully, 2) our quality system conforms to the current standard, and 3) we are always improving our systems. 

Our registrar, NAB, schedules audits on a one- or two-year cycle, depending on the length of time a company has been registered. Our practice is to hire an independent auditor to verify our compliance at about the midpoint between our registrar’s surveillance or recertification audits, ensuring that we remain compliant and up to date. A company that claims to be compliant without submitting to the certification process and regular audits is, by definition, non-compliant.

Maintaining our quality systems in full compliance is a cornerstone of ensuring that we develop safe and efficacious products for our clients and that the products we manufacture are reliable and meet customer and regulatory requirements, whether for medical, aerospace, or other markets.

HDA is registered to ISO 13485 for the design and manufacture of medical devices. We are also registered with the FDA and California FDB to manufacture medical devices. 

If you have additional questions about our certifications and standards or would like to request a consultation, you are invited to get in touch.

HDA Technology has carved out a name for itself in the medical device manufacturing world by embracing specialty projects instead of going the mass production route. This focus means we can help your company develop quality products and maintain compliance with all procedures and processes. We’re good at what we do; our decades of experience mean your specialty project is in good hands.

The Boutique, Craftsman Approach to Medical Device Manufacturing

In the realm of medical device development and manufacturing, the choice between a boutique, craftsman approach and high-volume, automated strategies isn’t just a matter of production scale; it’s a fundamental decision that can profoundly impact the quality of your medical devices. The craftsman approach ensures that complex devices receive the full attention of highly trained personnel. 

Embracing a boutique, craftsman approach for medical device contract manufacturing offers several distinct benefits that can significantly enhance the value and impact of the devices we build together.

Precision and Attention to Detail

The craftsman approach prioritizes precision over mass production. In medical devices, where individual patient needs can vary significantly, this approach allows for tailored solutions. Boutique manufacturers like HDA Technology can closely collaborate with clients to create devices that meet very specific customer requirements, resulting in improved outcomes.

Innovation and Flexibility

Smaller, boutique firms often have greater flexibility to innovate. This is absolutely true for us here at HDA. We can swiftly adapt to emerging technologies, respond to market demands, and incorporate the latest research findings into our designs. This agility fosters a culture of innovation, enabling the development of cutting-edge medical technologies that may not be feasible within the constraints of mass production and automation at bigger manufacturers.

Quality Assurance

A craftsman approach at HDA places a premium on quality. Here, every device is meticulously assembled and rigorously tested to meet the highest quality standards. This dedication to quality assurance is especially crucial in the medical field, where patient safety is paramount. Boutique manufacturing prioritizes quality over quantity or speed, ensuring that each device is held to the highest standards.

Niche Markets and Specialization

As a boutique manufacturer, HDA often caters to niche markets and specialized technical requirements. By doing so, we can act as content experts, offering unique insights and solutions that address our client’s unique challenges. This specialization fosters trust with our clientele and contributes to their success.

As you can see, a boutique, craftsman approach to medical device development and manufacturing offers a range of benefits that extend beyond the production process. It helps HDA to prioritize precision, customization, innovation, and quality assurance, all of which contribute to improved business and patient outcomes and satisfaction. 

While mass production and high automation strategies have their place, the unique advantages of the boutique approach make it an invaluable choice for your medical device applications, especially those where individualized care and innovation are paramount.

Low Volume, High Skill Sets

Our years of experience in medical device development and manufacturing allow us to appreciate the significant benefits of a low-volume approach. 

First, it allows us to maintain an unwavering focus on precision and quality. By eschewing the pressures of high-volume production, we can allocate more time and resources to perfecting each device, ensuring it meets the highest customer and industry standards. This dedication to quality not only enhances the reliability and safety of our products but also bolsters our reputation as a trusted partner.

This agility allows us to remain at the forefront of medical device innovation, taking part in creating solutions that not only meet but often exceed the expectations of the diagnostic and therapeutics communities. We build equipment for use in treatment rooms, operating rooms, and doctors’ offices. These devices change healthcare outcomes in real-time. In essence, our low-volume, high value-add approach enables us to combine the wisdom of experience with the spirit of innovation, ultimately benefiting both our clients and the industry as a whole.

Design, Production, and Support with Experience

HDA Technology boasts a team of experts with strong technical backgrounds and deepskill sets, educated and knowledgeable in their respective disciplines and quality management. We maintain stringent compliance with the procedures and processes needed to develop and manufacture your next device. 

Our focus is primarily on electronics and technological equipment. We specialize in the creation of advanced diagnostic and therapeutic medical devices for the healthcare industry, with a particular focus on durable and capital devices. 

With a legacy of innovation spanning decades, we have earned a reputation as pioneers in developing cutting-edge technical solutions that enhance patient care, streamline healthcare workflows, and improve overall clinical outcomes. Our commitment to excellence and our deep understanding of the unique challenges within the healthcare sector has positioned us as a trusted partner for healthcare providers worldwide.

Our portfolio encompasses a wide range of intelligent electronic and electromechanical medical devices, from durable equipment such as patient monitors and diagnostic tools to capital equipment systems. We pride ourselves on leveraging the latest advancements in technology to create devices that not only meet the highest industry standards but also address the evolving needs of modern healthcare. 

Through rigorous research, design, and testing, our medical solutions empower healthcare professionals with the tools they need to deliver more precise and efficient care, ultimately enhancing the patient experience and advancing the state of healthcare technology.

If you’d like to learn more, it’s time to get in touch. HDA Technology is here to talk through your next project and assess it to see if we’re a good fit for your development and manufacturing needs. 

The medical device product development journey is fraught with peril. Startup and early-stage medical device developers can be hindered by so many hiccups:

• Funding and expense issues
• Stakeholder disagreements
• Not planning ahead for potential problems
• Extended timelines
• Regulatory blockers
• Testing shortcuts and other mistakes
• The competitive landscape

Those are just a few of the problems that can throw a young medical, biotech, therapeutics, or medical device startup off-course. That’s where HDA comes in. We have a proven track record of keeping companies moving forward along their development trajectory. As a full-service medical device contract manufacturing firm, we can help you do it safely, quickly, and within budget.

The goal of every medical device (and its makers) is to help others and enhance their quality of life. In recent years, regulations have become stricter to ensure the safety of patients and users. The intention is for manufacturers to prioritize quality and minimize risks associated with the device. Nevertheless, it can be challenging and even overwhelming to navigate the journey of developing a medical product without assistance. Here are three ways in which HDA can be of service for these challenges.

How HDA Can Help: Defining the Journey

HDA specializes in supporting startups and younger companies in their journey to create innovative medical devices. We understand that the earliest ideas and design stages of a medical device are crucial, as they lay the foundation for a successful product. This is what we mean when we ask,” How are you defining your journey?” What is your ultimate goal? Who is your target audience? And what is your timeline?

Our team of experienced engineers and designers is well-equipped to collaborate with you from the very beginning, helping you refine your ideas, conceptualize designs, and translate them into viable prototypes and, ultimately, production

We recognize that startups and younger companies face unique challenges when it comes to medical device development. Limited resources, lack of in-house expertise, and the need for cost-effective solutions are just a few of the obstacles they may encounter. That’s why we offer comprehensive support during the earliest stages of device creation. 

We can assist you in product definition and feasibility studies, identifying regulatory requirements, and developing a solid product roadmap. With our guidance, you can navigate through the complexities of the medical device industry with confidence.

When it comes to transforming ideas into tangible medical devices, we pride ourselves on our ability to deliver high-quality solutions. Our firm utilizes state-of-the-art tools, technologies and advanced manufacturing processes to ensure that your device meets the highest standards of precision, reliability, and safety. From concept development to prototyping, we work closely with you to refine and optimize your designs, considering factors such as manufacturability, scalability, and cost-efficiency. 

Our aim is to help you bring your medical device to market faster while maintaining exceptional quality and compliance with regulatory standards. With our expertise and collaborative approach, we are committed to being your trusted partner throughout the entire journey of medical device creation.

How HDA Can Help: Identify A Target Market

We understand the challenges in identifying the right target markets for medical devices in development. For younger companies, this task can be daunting and complex. That’s why our team of market research experts is dedicated to helping our clients navigate through this crucial step. 

We utilize a combination of market analysis, competitor research, and user feedback to identify the most promising target markets for your medical device. By gaining a deep understanding of the healthcare landscape and emerging trends, we can help you make informed decisions that maximize your device’s potential in the market.

Our approach to identifying target markets goes beyond basic demographics. We take into consideration factors such as unmet needs, market size, regulatory requirements, reimbursement policies, and the competitive landscape. 

Our experienced team helps to conduct comprehensive market research and analysis, exploring opportunities in both domestic and international markets. By examining existing gaps and evaluating the potential demand for your medical device, we can provide valuable insights that enable you to make strategic decisions about market entry and commercialization.

At HDA, we recognize that target markets may evolve as your medical device progresses through the development process. Our flexible and iterative approach allows us to adapt our market analysis and recommendations to align with the evolving needs of your product. 

We collaborate closely with our clients, leveraging their domain expertise and our market research capabilities to continuously refine the target market strategy. Our goal is to help you identify the most viable markets for your medical device, ensuring that your product meets the needs of patients, healthcare providers, medical device assembly companies and other vendors, and key stakeholders while achieving commercial success.

How HDA Can Help: Develop Regulatory and Testing Strategies

Regulatory compliance and testing play big parts in the successful development of medical devices. From the earliest stages of development, we work closely with our clients to devise smart and timely regulatory strategies. By conducting thorough assessments of applicable regulations and standards, we can help to ensure that your medical device meets all necessary requirements. Our team also assists in compiling regulatory submissions, managing communications with regulatory authorities, and navigating the approval process to help you achieve timely market clearance or approval.

In addition to regulatory compliance, there is the importance of rigorous testing to ensure the safety, effectiveness, and reliability of medical devices. Our experienced testing and validation team collaborates with clients to develop comprehensive testing strategies tailored to their specific products. 

We help you identify the appropriate testing methodologies and standards, plan and execute validation studies, and analyze and interpret the resulting data. By leveraging our expertise and understanding of industry best practices, we guide you through the testing process efficiently and effectively. Our goal is to assist you in obtaining the necessary evidence to support the claims and performance of your medical device, ultimately positioning it for market success while meeting all regulatory requirements.

Get In Touch

HDA’s experts are familiar with the blockers you face today at any stage of your medical device development journey. Get in touch — we can help.

HDA is a full-service medical device prototyping and contract manufacturing company. Our team boasts decades of experience providing top-grade services to medical startups, mid-size companies, and multinational corporations. We provide development and manufacturing services at any point in your product’s life cycle — including prototyping and compliant pilot production.

We have the technical and practical experience to get your low-volume orders out on time with consistent, high-quality craftsmanship. Our FDA-registered facility is capable of producing medical devices of every classification; Class I, Class II, and Class III. In addition, if you need help proving the critical functions of your innovative medical device concept, HDA can develop and manufacture industry-standard prototypes to your exact specifications.

Because medical device prototyping is a multilevel process, our work is all about consistent quality checks and due diligence. Utilizing the prototype model allows HDA and our clients to work with physical devices as opposed to virtual designs. Feasibility can be more directly assessed and the cost savings are significantly reduced as a result. 

Partner with HDA for Your Medical Device Prototyping

Our full-service medical device manufacturing team is led by expert engineers, technicians, and seasoned regulatory specialists. We can get your product ready as quickly and safely as possible. If you’ve identified a need for your medical device in the healthcare industry, we can help bring your product into reality. Our refined development and manufacturing process is ready to meet your unique production goals and efficiently produce working prototypes.

Designing a groundbreaking medical device concept and getting it to market is filled with complex and intricate processes. These can often be daunting for many companies. HDA is ready to help you to navigate the prototype production phase and handle any necessary regulatory certifications during the process. In addition, our time-proven development and evaluation procedures allow you to test your product and confirm its primary functions.

Medical device prototyping with HDA can benefit your product development in several ways:

• Accelerate Development. HDA’s ability to manage full-service prototyping under one roof offers more control and efficiency over the development process. In addition, we will implement proven strategies and procedures to quickly and effectively develop your product the right way.
• Test and Evaluate. Medical device prototyping allows for the testing and evaluating of your product’s design and functions. HDA will help develop and improve your concept to ensure its critical role.
• Ease Regulatory Process. HDA will ensure the design process supports your product’s intended function. In addition, we test and document development methodology.
• Documented Designs. We document the design and development of your medical device with an industry-standard design history file (DHF). The DHF records all changes to your concept during the product and production process. In addition, regulatory certification necessitates instruments to document development histories.
• Minimized Costs. We lower future high-volume production costs through the medical device prototyping process. Our optimized production methods inform the full-scale production methods required for your market-ready product. This cost-effective manufacturing benefit saves money and time. 
• Improve Safety. More than 1.7 million injuries from medical devices have been recorded over the last decade. HDA mitigates patient and consumer injuries with thorough prototyping development, evaluating and improving product safety. We refine your product’s design at every stage of development to create a better, safer medical device.

HDA’s approach to medical device prototyping provides your product with a clearly defined development plan to make sure there are no surprises along the way. We have industry-best personnel and development processes to get you through product design, manufacturing, and successful regulatory compliance. In addition, we consider the entire life cycle of your product from inception to market.

Ready for Your Medical Device with Compliant Pilot Production

Do you want to begin clinical testing on your newest medical device product? Are you ready to file a 510(k) premarket submission with the FDA? 

HDA offers compliant pilot production to fulfill low-volume, audit-ready products orders. Our FDA-registered facility is capable of producing completely compliant medical devices to meet your needs. Leverage our facility, experienced engineers and technicians and regulatory specialists to create fully compliant, high-quality products.

We look at compliant pilot production as a crucial step toward full-volume manufacturing for your medical device. Our processes are refined and ready to be implemented in full-volume production after successfully moving your product into clinical trials or a pilot market. Additionally, compliant pilot production also allows us to uncover any issues that may impact the manufacturing process. HDA uses this stage to refine production processes and help you refine your product design as well.

At HDA, we utilize scalable and replicable processes to guarantee your products’ long-term success and quality. We test your device’s design and manufacturing process to ensure it consistently produces functional, safe products without significant or costly issues. 

Combining engineering-based transfer to manufacturing and procedure-based assembly ensures that each device meets its critical function and design before leaving the manufacturing facility. In addition, we prioritize testing and evaluation processes dedicated to optimizing quality and efficiency during medical equipment contract manufacturing and production. 

HDA’s compliant pilot production services include several benefits:

• Design Verification. Throughout the development process, HDA actively verifies your product to ensure it fulfills predetermined functions and safety requirements. In addition, we can mitigate functional and safety issues before the product reaches the manufacturing stage by aligning our design output with the design input.
• Design Validation. HDA implements stringent design controls that inform our development process through development and manufacturing. Our comprehensive validation process confirms the product’s usability, critical function, and safety before it reaches manufacturing. 
• Low-Volume Manufacturing. Our manufacturing team and facility can easily scale to manage low-volume and clinical orders efficiently. We utilize a lean manufacturing process to reduce lead time and mitigate wasted cycles during production, saving customers time and money while providing expertly-crafted results.
• Optimized Development Process. HDA jump-starts the planning and optimizing of your product’s development life cycle. Implementing crucial processes to streamline development — including testing and evaluation — allows us to do so. We eliminate costly mistakes and delays by adhering to time-tested procedures.

HDA upholds specific and stringent standards throughout the development process to make sure your 510(k) filing or clinical trials move forward successfully and on time. In addition, our low-volume manufacturing methods are proven to save time and reduce production mistakes that lead to costly delays. 

Develop your next prototype or low-volume pilot with HDA, and you’ll receive expert engineering, optimized development, and advanced manufacturing to ensure the long-term success of your next innovative medical device.

As a full-service medical device manufacturing company, HDA offers many different manufacturing services to fulfill the needs of our customers. We’re ready to leverage our decades of knowledge and experience to help you create the following big product. So reach out to us today and tell us all about your new idea!