Medical Device Engineering Market

Medical Device Engineering Market Size, Share & Trends

The medical device engineering market is expected to generate a revenue of USD 14.7 billion by 2029, with a revenue of USD 9.0 billion in 2024 to register a CAGR of 10.1%. The growth of the market is driven by a host of factors: rapid advancements in medical technology, an increased incidence of chronic diseases, and stringent regulatory requirements. For example, the rapid upsurge of wearable health monitors like Fitbit and Apple Watch calls for advanced engineering services that can achieve high accuracy and integrate them with other health systems. Moreover, the aging population in the world requires sophisticated gadgets for diseases such as diabetes and other cardiovascular disease management. This serves as another driving force towards innovation and development. In addition, regulatory bodies such as FDA will make a demand in specialized engineering services towards compliance and safety, whose stringent requirement is to test and validate a medical device through rigorous exercises.

Medical Device Engineering Market Trends

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Medical Device Engineering Market Dynamics:

DRIVER: Industry 4.0 significantly impacting the medical device engineering market

Improved Industrial Engineering Processes in Medical Devices with the maturation of Industry 4.0, propelled by loT, Al, Robotics, and Big Data Analytics, a forcible push is made to medical device engineering . These technologies help to innovate in the creation of smarter, more connected devices that, in real-time, could do predictive maintenance, enhanced engineering, reduced downtime, and more precision in diagnostics and treatment. It automates advanced manufacturing techniques, inclusive of 3-D printing, which allows fast prototyping and personalization to realize enhanced efficiencies and reduction in time-to-market. Added to that, data analytics and machine learning will assure continuous improvements in device performance and outcomes regarding the patient while maintaining compliance and quality.

• In November 2022, L&T Technology Services Limited, headquartered in Mumbai, opened two new design and prototyping centers in Peoria, Illinois, at 1DigitalPlace and the Electrification & Prototyping Center. For the growth of digital engineering programs for the customers, the centers will offer advanced services in the digital manufacturing and electrification solutions across transportation, medical devices, and high-tech sectors.
• In January 2022, HCL officially opened its Innovation Center for Engineering and R&D services in Edmonton, Alberta. The Edmonton Center includes an engineering and co-innovation laboratory where clients from the TTC, the city, and utilities of all sizes, including Fortune 100 leaders, can reimagine their products, speed up the prototyping of their products, collaborate in research and participate in continual learning to deliver on accelerated time-to-market.

This has thus led to Industry 4.0 acting as the catalyst toward radical evolution and escalation in the medical device engineering market by way of innovation, improvements in functionality, and process optimization.

RESTRAINT: High costs and investment demands will constrain growth

High costs and high investment are major reasons that retard the growth of medical device engineering markets; in effect, these make it very difficult both for the existing players and the new entrants. Actually, a lot of R&D activities go into developing a medical device and require advanced technologies, specialized equipment, and highly skilled personnel. It is a very iterative and complex process that might go through cycles of designing, prototyping, testing, and refinement before a workable product results. This does not only lengthen the development time but also makes it more expensive due to the continuous need to invest in state-of-the-art laboratory facilities and in the latest technological developments. Clinical trials are also conducted for medical devices to be developed as an integral part of the process, aiming at proving safety and efficacy. These trials are very expensive, with huge budgets required for subject recruitment and compensation, getting approvals, and other associated costs for rigorous compliance with regulatory requirements. To many SMEs, such high entry barriers are hard to overcome with limited financial means. Development and regulatory costs must be added to the already substantial investment needed to secure IP rights that can first prevent infringement of the innovation, then establish a competitive edge in the marketplace.

OPPORTUNITY: Growing complexities of medical devices

The increasing complexities of medical devices are believed to offer a huge opportunity in the medical device engineering market. With further advancements in the medical devices space touching on artificial intelligence, machine learning, IoT connectivity, and miniaturization, the demand for specialized engineering services is increasing. Such complexities will, therefore, demand a multi-disciplinary approach to design, development, and manufacturing, entailing deep knowledge bases in fields such as biomedical engineering, software development, electronics, and material science. The need to integrate state-of-the-art technologies in medical devices for their functionality, accuracy, and usability has brought along a set of new challenges that many medical device companies, particularly the smaller ones, might not be equipped to handle in-house. This develops a high demand for specialized engineering services to avow the expertise and resources needed to negotiate such challenges effectively. With the tightening of regulatory standards on both the safety of patients and product efficacy, stringent and fully complaint engineering solutions will be needed more than ever before. In this regard, a seasoned engineering service provider may become critically important in these complex regulatory landscapes and aid in ensuring that the product can reach the prescribed standards while also getting timely market exposure.

CHALLENGE: Concerns regarding toxic fumes produced during surgical procedures

This concern for cybersecurity is one of the most potent challenges to the development and deployment of medical devices. Nowadays, medical devices are extremely connected, interdependent on software, and digitally enabled, thus raising the prospect of cyber risks. Essentially, this increased risk stems from the digital convergence between the healthcare and information technology sectors, which, although enhancing capability and functionality in medical devices, exposes them to a number of cybersecurity vulnerabilities. Such devices as pacemakers, insulin pumps, and diagnostic equipment often collect sensitive data on patients and transmit them. Since it is connected with the safety of patients, the confidentiality, integrity, and availability of this data are critical. Breaches may lead to the most undesirable consequences: risks for patients, loss of confidence, and several legal issues. Hackers can change the functionality of devices, gain access to private health information, and disrupt critical medical services, which turns into direct threats to patient safety and public health.

Medical Device Engineering Market Ecosystem:

Leading players in this market include well-established and financially stable service providers of medical device engineering . These companies have been operating in the market for several years and possess a diversified product portfolio, advanced technologies, and strong global presence. Prominent companies in this market L&T Technology Services Limited (India), Infosys Limited (India), HCL Technologies Limited (India), Cyient (India), and TATA Consultancy Services Limited (India).

The software development & testing services of service type segment expected to grow at the highest CAGR during the forecast period of the global medical device engineering industry

In order to decrease development costs and time-to-market, while accessing specialist expertise, many medical device companies began to outsource their software development and testing activities to a combination of specialized service providers. Outsourcing provides the company with an appropriate justification to focus on its core competencies while leveraging the skills, enhanced capabilities, and related efficiencies that such providers bring to the partnership. This trend in outsourcing has been driven by customer demands to produce high-quality and compliant software in a growingly complex environment of regulatory and assurance requirements, which support right-first-time and cost-effective product development and deployment.

The diagnostic imaging equipment of device type segment expected to grow at the highest CAGR during the forecast period of the global medical device engineering industry

The diagnostic imaging equipment segment is expected to exhibit the fastest CAGR within the global market for medical device engineering market, mainly due to increased emphasis on detecting diseases very early to enhance treatment outcomes. Early detection is more effective for controlling chronic conditions as well as for the prevention of disease progression; therefore, more advanced imaging devices tend to have a progressively greater rate of utilization. High-resolution and 3D imaging technologies, combined with the incorporation of AI and machine learning, allow for in-patient malfunction identification accurately and at a super-fast speed. All these efforts in early detection benefit patient care and result in fewer expensive healthcare costs and less demand for advanced diagnostic imaging, leading to huge market growth in this sector.

APAC is estimated to be the fastest-growing regional industry

The medical device engineering market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa based on the region type. North America accounted for the largest share of the global medical device engineering market. In 2023, APAC is estimated to be the fastest-growing regional market for medical device engineering market. Improvements to the regulatory framework, particularly in countries such as China and India, have maximized the ease of developing and marketing new medical devices, thereby increasing engineering services in demand. This would mean fast-track procedures for approval, easy-to-follow guidelines, and better support for innovation that help the companies sail through regulatory requirements. For instance, China's National Medical Products Administration has been undertaking reforms that increase the speed of approval for devices, and policy support from the Central Drugs Standard Control Organization in India helps the clearance of products faster. Such regulatory developments encourage investment by domestic and foreign companies in developing high-end medical technologies, increasing demand for specialized engineering services in order to ensure compliance and quality.

Geographic Snapshot: Medical Device Engineering Market

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Key players in this market are adopting several organic and inorganic growth strategies (such as product launches, agreements, collaborations, acquisitions, and expansions). Prominent players in this market include L&T Technology Services Limited (India), Infosys Limited (India), HCL Technologies Limited (India), Cyient (India), Wipro (India), Tech Mahindra Limited (India), TATA Consultancy Services Limited (India), FLEX LTD (US), Capgemini (France), Embien Technologies India Pvt Ltd. (India), Alten Group (France), Accenture (Ireland), Consonance (Poland), Althea Group (US), MED INSTITUTE (US), Saraca Solutions Private Limited (India), Nemedio Inc. (US), Sternum (Israel), Medcrypt (US), MCRA, LLC (US), North American Science Associates, LLC (US), MedQtech (Sweden), Veranex (US), Ontogen Medtech LLC (US), Seisa Media (US), and Simplexity Product Development (US).

Scope of the Medical Device Engineering Industry:

The research report medical device engineering market to forecast revenue and analyze trends in each of the following submarkets:

By Service Type

• Product Innovation & Design/Industrial Design Services
• Prototyping Services
• Electronics Engineering Services
• Software Development & Testing Services
• Connectivity And Mobility Services
• Cybersecurity Services
• Product Testing Services
• Regulatory Consulting Services
• Product Support & Maintenance Services

By Device Type

• Diagnostic Imaging Equipment
• Surgical Equipment
• Patient Monitoring Devices & Life Support Devices
• Medical Lasers
• Ivd Devices
• Other Medical Devices (Ophthalmology, Dental, Durable Medical Devices, Lab Equipment and Others)

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of LATAM
• Middle East & Africa
  • GCC Countries
  • Rest of MEA

Recent Developments of Medical Device Engineering Industry:

• In May 2024, Infosys Limited (India) acquired InSemi Technology Services Pvt Ltd. (India). The strategic investment in InSemi underscores Infosys’ dedication to the semiconductor ecosystem and enhances its expertise in Engineering R&D services. This acquisition aims to deliver comprehensive end-to-end product development for global clients..
• In November 2023, L&T Technology Services Limited (LTTS) (India) collaborated with NVIDIA Corporation (US), to develop software-defined architectures for medical devices focused on endoscopy, which will enhance the image quality and scalability of products.
• In October 2023, Alten Group (France) acquired East Japan Institute of Technology Co., Ltd. (Japan). This acquisition aligns with ALTEN’s strategy to expand its engineering capabilities in Japan and achieve a critical mass, positioning itself as a leading provider of engineering services in the country.
• In January 2022, HCL Technologies Limited (India) acquired Starschema (US). The strategic acquisition will enhance HCL’s digital engineering capabilities, particularly in data engineering, and expand its presence in Central and Eastern Europe.

Frequently Asked Questions (FAQ):

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