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What are Medical Devices Engineering Services?
Medical devices enhance the quality of life by supporting patients, operators, and keeping related risks at a minimum. While they offer significant benefits, their introduction to the market is governed by stringent regulations, some of which have heightened over recent years, especially those associated with quality management and device vulnerabilities. Even prior to product launch or devising the go-to-market strategy, navigating the product development lifecycle requires intricate methodologies. The journey of medical equipment engineering from conception to market-readiness can be complex, given the dynamic and demanding nature of the medical technology solutions domain.
The medical device engineering and related services market was valued at US $4.98 billion 2024 and is expected to reach an approximate value of US $5.58 billion by the end of 2025 and furthermore US $8.65 billion by 2029, surging at a CAGR of 11.6% during the forecast period of 2024 to 2029. The rise in such developments can be attributed to an increase in chronic diseases, pandemics, healthcare-related funds and budgets, adoption of home-based healthcare and remote patient monitoring, elder population, telemedicine, personalized and precision medicine, as well as expansion of medical device engineering companies. Let us go through the medical device design and development process in this blog.
Source: The Business Research Company
Increasing market size of medical device development services
Phases of Medical Equipment Engineering
Given below is a generic overview of various stages of medical device development services, which may vary as per business requirements, market size, budget, features, device class, risk associated etc. These steps provide a snapshot of best practices, different types of obstacles as well as opportunities that companies face during such development –
Phase I: It is the foundational stage which mainly includes initiation of development, mind mapping, identifying the market and related benefits, opportunities, and problem statements from physicians, patients, technicians, hospital administrators, etc. to shape clinical utility. Here, medical devices engineering services also concentrate on biological and financial risk assessments, along with feasibility studies, manufacturing capabilities, regulations and challenges involved, associated planning, research on equivalent devices in the market, consideration of clinical trial data analysis, as well as modes of documentation.
Organizations mainly plan which geographies to enter and which markets to disrupt and how to do so with their new innovations. It is also important to consider patenting a newly developed product or idea to protect such intellectual properties. It also involves establishing quality management standard operating procedures, templates, forms etc. to control such activities and adopting ISO 13485:2016, a well-known industry standard incorporated by medical product design companies.
Phase II: This stage involves formulating device development and its conceptualization, which includes resolving the client’s requirements or patient-related issues. It lays down the pathway for detailed viability and financial feasibility analysis, risk considerations, mitigation, region-wise safety, regulatory and product submission requirements, and the right approach for realizing the device’s functionalities. Patient feedback, interviews, surveys alongside market research and thorough competitor analysis are a must, all of which can be adopted into the initial product design. It also involves the development of proof of concept, defining market positioning and securing funds for trial runs, and medical prototype development.
Phase III: This is the main design, development, and assembly phase after iterative prototyping and clinical trials, which is followed by verification and validation processes. It is necessary to ensure that the device performs as intended in the real world, and therefore certain criteria-based tests are set up for acceptance. Keeping patient requirements in mind, a traceability matrix is formed as per design for manufacturability principles for optimization to track the same. It involves establishing sync between customer and device engineering solutions and related requirements by devising steps to fulfill client needs, modes of testing for verification and validation, processes included, and testing tools needed to develop diagnostic and therapeutic equipment.
Furthermore, certain important steps can be devised by medical devices engineering services such as in the case the product is made suitable for manufacturing, quality management system, and outsourcing options. Businesses also consider risk management practices targeting patient safety in this stage such as documentation of potential failures, reasons for the same including poor design, issues with the development procedure, consequences of misuse by the operator, etc. All external approvals, ethical and regulatory strategies must be updated with time including clinical trials that were conducted during the initial prototyping stage can be implemented in real-time clinical environment to freeze the design.
Phase-wise development process followed by medical device design consultancy
Phase IV: This stage involves final approvals, validation, and preparation for product launch onto the market, which includes marketing and branding strategies. The marketing literature and claims must be validated and backed by evidence and specific justification. Businesses are required to consider the quality system, HIPAA and other FDA regulations for medical devices like 21 CFR Part 820 while marketing products. All evidence related to validation and verification testing must be technically documented including electrical safety, shipping, stability, biocompatibility, usability, durability, and presented before a competent authority for further review.
Phase V: Once the product is validated and prototyped, the next step is navigating the regulatory landscape and preparing for market launch. Ultimately, the product is launched into the market after the final team review which includes latest and complete documentation, checking for re-testing such as through regression testing, revalidation testing, post-market surveillance strategies, feedback/complaints capture plans and adverse event reporting, finalization of labeling, assembly and packaging, records of major changes if any, design transfer involving design history files for further full-scale production etc. After gaining license and certificate on product and technical file submission (FDA510(k), PMA, De Novo routes), the product can be successfully placed in the market with the help of medical device design consultancy. All internal systems need to be continuously reviewed and improved as per customer feedback. A quality auditing system must be in place to review all records, sterilization, complaints, technical documentation, quality management and improvement procedures, supply chain management, good manufacturing practices, tooling for pilot and full-scale production, resource utilization, etc.
Advantages of Medical Devices Engineering Services
Businesses need end-to-end support when launching new innovations via MedTech development services and introducing them into the market. Amalgamating such services in complex design, development and other processes can benefit them in a plethora of ways. Since these procedures follow intricate pathways, showcase high return on investment and are directly associated with improving patient lives, compliance with regulations, industry standards, and vigilant authority checks should never be rushed. Given below are the various advantages offered by medical device engineering companies –
Regulatory Compliance
These companies understand the intricacies involved and ensure through compliance consulting that businesses can easily traverse complex and challenging processes of obtaining ISO certifications and regulatory approvals. These labels not only mark quality and safety but also form mandatory legal requirements.
Domain Expertise
Alongside decades of experience in designing and production, these companies utilize state-of-the-art technologies, methodologies, tools, equipment and machines for milling, turning, cutting, grinding, molding, laser processing and finishing etc., to make sure that the product developed qualifies for the highest, world-class medical device engineering standards. This is necessary to ensure that the innovative solutions produced are effective and competitive enough to gain profits from the market.
Development Support
Businesses receive comprehensive support across all stages of regulatory-compliant hardware and software design and development, like for medical inventory management software. Medical device engineering companies make sure that the client can navigate all development phases seamlessly right from conceptualization, designing, prototyping, benchtop testing, manufacturing to market launch. They strive to minimize the timeline and costs for development as well as tackle any challenges in coordination to accelerate product launch.
Device Waterfall and FDA-referenced diagram followed by medical product design companies
Integrated Manufacturing
These services offer in-house manufacturing competencies, where original ideas can be easily converted into real-life products through collaborative partnerships. This enhances scalability, compliance with stringent regulatory and quality standards, and flexibility in the entire process. Moreover, businesses benefit from uniform product quality and swifter turnaround time with circuit board design and manufacturing services.
Strategic Partnership
Co-creation forms the basis of stages of product design and development between medical device contract manufacturing companies and customers looking to develop their ideas into market-ready products. The former makes sure the company vision stays un-wavering in all aspects of the developed product and also in terms of patient requirements. Successful implementation of such an approach is guaranteed through close collaborative partnerships amongst designers, customers and engineers during computer-aided design modeling, selection of production raw material, and rapid prototyping.
Quality Assurance
Medical device development services also perform adequate medical device testing and high-quality assurance to ensure optimal performance, reliability, integrity, and safety of the device. This includes various validation measures, testing procedures, and quality control protocols to make sure compliance with regulatory standards and that the best of product quality is met at all times.
Others
These companies let the clients focus on core business operations such as manufacturing, marketing, research, etc. to reduce supply chain costs, waste, lead times and enhance quality and reliability while following strict tolerance parameters as per the medical domain. They assist in bringing the new or updated product to the market quickly through better technological advancements, quickly hiring and retaining domain expertise or staff during industry shortages.
Make Your MedTech Innovations Market-Ready with KritiKal
In this blog, we went through an outline of medical equipment engineering right from their conceptualization to market stages. We saw the various advantages of such service providers that assist in end-to-end production and prove to be value-added engineering through strategic partnerships. Development services, comprehensive support, process simplification, design traceability, extensive process visibility, quality assurance, and smooth transition across all developmental stages of the product lifecycle offered by innovators like KritiKal Solutions contribute significantly to innovation and efficiency in healthcare technology development. They ensure collaboration, high-quality standards, product reliability, regulatory compliance through extensive domain expertise and in-house development capabilities. Businesses can utilize our services as a turnkey solution to accelerate their product development and commercialization journeys and deliver life-changing medical devices to the market. As MedTech continues to evolve, collaborative innovation and regulatory readiness will remain key. KritiKal Solutions is ready to guide you through every step of the journey. Please get in touch with us at sales@kritikalsolutions.com to bring your product concepts to life and realize your personalized healthcare ideas.
Subhajit Sarkar currently works as a Senior Embedded Systems Engineer at KritiKal Solutions. He has more than 10 years of experience in Software and Hardware development, controller level board troubleshooting, and customization of different microcontrollers. With an extensive skill set of Embedded C, MPLAB, Code Composer Studio, Hardware designing – Analog & Digital, Ki-Cad, Altium, OrCAD Multisim and spice tools etc., he is adept in end-to-end embedded systems development and has efficiently delivered some major projects.