We lead all project stakeholders through each step of our process to achieve remarkable outcomes.

Our quality team guides clients through activities and deliverables needed to meet regulatory requirements, such as project planning, risk management activities, multi-partner quality agreements, design controls, use flowcharts, and biological evaluation planning.  HaA is able to deliver world-class design and development services for Class I, II, and III medical devices while utilizing the Greenlight Guru eQMS platform.

The general philosophy behind HaA is delivering on time and on budget, which is not common in device development, while achieving high performance via an experienced team of highly skilled individuals. This team includes, but is not limited to, project and program managers, mechanical and biomedical engineers, quality managers, marketing personnel, industrial designers, and human factors professionals. 

The entire HaA team understands the importance of quality and is aligned on ensuring that devices are developed with the goal of achieving regulatory compliance. 

Achieving regulatory compliance starts early in the design and development process, with market research. This includes researching emerging technologies, new materials, and conducting competitive product analysis.

The goal of this research is to understand all inputs and clearly define goals and the purpose of the product as well as the required features for commercial success. 

Regulatory strategies are formulated early on. Our knowledgeable team is familiar with  product-specific regulatory requirements, predicate devices, and validation processes to properly support 510(k) submissions with substantial equivalence documentation. We also develop premarket submissions for complex devices, including safety demonstrations and predicate comparisons.

Then we dig into concept pro builds, analyze strengths and weaknesses via the use of usability evaluations, understand that the goals are met, and refine the repeat prototype.  

Regulatory planning is a complex process for medical device companies. Not only do we lead our clients through proper planning activities to ensure FDA approval, but we also  understand and know how to implement the requirements for our clients registering as spec developers. We lead all aspects of assisting companies to become registered as spec developers and, as required by ISO 13485, help them to put in place their own QMS system. 

This is critical for start-ups and inventors who want to build a prototype and manufacture their own products. As a spec developer, you are required to have post-manufacturing tracking for any complaints, quality issues, and failures. Spec Developers must be FDA-registered. If they will be their own manufacturer, we can guide them through the process to become a FDA-compliant company, developing and implementing a quality management system to confirm that our medical device design process complies with FDA QSR 21 CFR 820 and ISO 13485:2016 standards. Our team of designers and engineers provides regulatory guidance and consulting for the US, EU, and global markets, and can conduct gap assessments of existing product development programs to identify opportunities for improvement. 

We prepare the documentation necessary for regulatory submission planning and content development to meet FDA requirements. HaA PD specializes in developing engineering specifications, and we assist with regulatory compliance throughout the approval process.

For research and analysis, we conduct the incredible exercise, which is inclusive of stakeholder interviews and contextual interviews to gain a deeper understanding of real-world device usage. We run in-person observation and focus groups to gain insights into clinical workflows and user needs so that the medical device we manufacture fits the client’s needs and expectations. The HaA PD team also organizes co-creation research and development sessions, as well as journey mapping exercises, to verify that devices meet actual clinical procedures and patient experiences.  NOTE: add identify concerns and then dig into why the concerns are raised and how certain they are of their concern /statement…looking to identify false beliefs based on thinking provided to people by prior people without confirming the accuracy, limiting beliefs that restrict progress; challenging confidence level of internal statements - eg, “we believe that if you coat this product with this, it will fail,” and follow up question “how do you know this” and “what is your confidence level that will occur”   

During the research and analysis stage, we conduct surveys and questionnaires to gather quantitative data complemented by competitive benchmarking analysis and thoroughly investigate past case studies. Heuristic evaluations and usability testing assess and confirm our design decisions. Simultaneously, we conduct task analysis and trend analysis to inform future development directions. These inputs help us to develop personas that our team uses to verify our design decisions throughout the product development process. 

To further support our designs, we conduct voice-of-customer interviews and key opinion leader (KOL) interviews to gain an effective clinical perspective on device requirements. To meet stakeholder needs, we work with user profiles and user groups. Field research and user interviews help our teams narrow down the clinical environments and user behaviors that best match the medical device.

Our design approach for concept development combines rigorous market research with visual design excellence in a manner that makes sure every interface concept meets the required clinical requirements. Our multidisciplinary team creates highly developed visual hierarchies and interfaces that guide users through complex processes without sacrificing visual appeal. We create responsive, scalable interfaces that adapt to changing configurations of medical equipment, remaining consistent across different clinical settings.

Through rigorous concept feasibility testing and iterative prototyping, we define interface designs against real-life medical scenarios. Our prototyping range ranges from wireframes to interactive graphical models actively tested within healthcare environments, being wholly compliant with all regulatory needs but with interface solutions that reduce visual fatigue, legibility, and user error throughout life-critical medical procedures.

Our UX design and concept creation services cross the gap between innovative new technology and life-saving healthcare solutions through commitment-based market research and clinical workflow analysis. Our process of concept development begins with extensive user research, and we make sure that every device concept addresses substantiated clinical requirements while maintaining competitive differentiation in the continuously changing medical device industry.

Through systematic concept feasibility testing and iterative prototyping, we test designs against real-world medical environments. Our prototyping facilities range from wireframes through interactive models tested directly in healthcare environments, achieving compliance with regulations while contributing directly to improved patient outcomes and optimizing healthcare delivery through excellence in user experience.

Human factors engineering includes developing a procedural map to optimize device usability to understand human factors and feature requirements. We implement use-related risk analysis to find potential use errors and associated hazards. Heuristic analysis assesses our interfaces against established usability principles specific to medical devices. 

Formative evaluations provide iterative feedback during development, while summative assessments measure the effectiveness of the final design. Iterative design testing emphasizes continuous improvement throughout the development process. The use and user interface specification documentation are based on design feedback and findings from quantitative and qualitative exercises. 

Human factors and usability engineering planning integrate human factors engineering (HFE) throughout the development process. If we spot potential use errors, we adjust our design accordingly. Our team develops user and usage requirements to support design decisions throughout development.

Industrial design services include conceptual sketches and detailed renderings throughout the design process. Color, material, and finish (CMF) are based on clinical environment requirements, cleanability, and durability. Our medical devices are carefully designed to match our clients' corporate identities while maintaining full clinical functionality. 

Our iterative design processes incorporate feedback loops with clinical stakeholders and regulatory requirements. We organize concept feasibility analyses early in development to assess technical and commercial viability. Breadboard refinement and working models provide rapid prototyping and design validation. 

HaA PD always seeks ways to reduce costs and produce competitively priced medical devices. We have initiated cost reduction initiatives that are integrated throughout the design development process. We validate design concepts through initial prototype testing and constantly look for improvement opportunities before investing in production tooling.

Engineering services include developing device requirements so that all specifications are clearly defined and traceable. Documentation begins early in our process with detailed drawings that follow ASTM EY 14.5 tolerancing. This defines manufacturing issues early, including injection-molded parts and metal parts, all of which are integrated into a master assembly with part-to-part relationships. 

Just prior to design freeze, we require a complete Part tolerance Overview. This is usually done by the design engineer who has familiarity with the overall assembly, thus ensuring proper tolerancing. After this, a full DFM is performed, which includes part-to-part clearances. 

The term that we use internally in our office is a tolerance-friendly design, meaning that each part can fit within the parameters and performance of the machine or equipment that is making it. Depending on the process, molded or machined stamps are produced. 

This design experience results in lower costs and more efficient production lines. It also makes all parties involved feel accomplished. When the ultimate output is tolerance-friendly, cost is reduced, which expedites the manufacturing setup. This makes management happy because the time to market and sales is drastically reduced. 

The output from the above process is a comprehensive CAD package, including detailed inspection drawings, assembly work instructions, and, in some cases, a list of manufacturing equipment. If equipment purchases are required, validation documentation can also be completed. 

Whether it's engaging with an existing manufacturer or setting up a new company with their own manufacturing, we'd recommend second sources from most of everything listed above. This helps ensure proper planning and the ability to sell and transfer End Quote 2 secondary manufacturers to cover potential sales needs. Worst case scenario? You can sell your product and get a backlog of orders, but are unable to provide or fulfill those orders. 

This is where second sourcing helps you competitively price your product. It also ensures that your product will always be available for sale. In today’s world of acquisitions, you need proper documentation in the world of product development so that you can move forward with the confidence of consistency and the ability to have sales and make money. 

Design and device requirement traceability reports allow us to track requirements throughout development. Product specification development includes detailed technical descriptions and performance criteria. 

A bill of materials (BOM) combines manufacturing considerations with design requirements. Pre-production builds assess designs and manufacturing processes before full-scale production. Manufacturing documentation packages, including work instructions, quality plans, and testing protocols, ensure the seamless transition from product to market. 

Our design and engineering team develops complete documentation packages that support regulatory submissions and manufacturing operations. We apply design for manufacturing (DFM) and design for assembly (DFA) principles for efficient production and cost-effective services in medical manufacturing.

Our range of medical services includes design for manufacturing (DFM) and design for assembly (DFA) optimization, which helps reduce production costs and improve quality. We source from the US and international supplier networks to achieve the best balance between cost and quality. We always look for ways to reduce costs through better engineering and manufacturing techniques, all while maintaining quality, regulatory compliance, and optimal performance. 

We provide complete documentation packages for our manufacturing process, including detailed work instructions, quality plans, and inspection protocols. Also, we assist our clients with regulatory submission and process validation support. Our HaA PD patent assistance services protect intellectual property throughout development and manufacturing. 

Our team helps with technology transfer for a smooth transition from development to production. Thanks to our expertise and professional experience, we minimize startup issues and ensure your medical device reaches the market quickly and efficiently.

We are a full-service, ISO 13485-certified, USA-focused, strategic medical device development partner for hundreds of Class I, II, and III medical devices. Our certification proves our commitment to quality management systems and regulatory compliance. 

With over three decades of medical device expertise, our staff knows how regulatory requirements work and the clinical needs and manufacturing challenges medical devices face. We work with a manufacturing mindset, from the initial concept to cost-effective manufacturing. We overcome challenges to develop innovative, high-performing medical devices that help the medical community do their work more effectively and safely. 

We have worked with hundreds of clients, including Verb, Insulet, Smith & Nephew, RadiaDyne, and Boston Scientific. Our clients came to HaA PD with challenges they faced during medical procedures, patient monitoring, and product re-design. We supplied our expertise and professional know-how, developing medical devices that met their standards and helping them improve them. 

We have developed a range of cardiovascular devices, catheters, monitoring systems, implantable devices, minimally invasive tools, robotic components, and precision cutting instruments throughout our work. We have also developed monitoring systems, diagnostic equipment, point-of-care testing devices, and imaging components.   

With HaA PD, you have a partner with a multidisciplinary team that combines engineering expertise with regulatory compliance. Our background, experience, and approach bring innovation to market efficiently and safely, while complying with stringent quality requirements. 

Contact HaA PD today or schedule a free strategic consultation to learn how we can help bring your vision to life!