Medical Device Design And Development Services Market Size, Share & Trends Analysis Report By Services (Designing & Engineering, Packaging), By Medical Devices (Drug Delivery Services), By Therapeutic Area, By End use, By Region, And Segment Forecasts, 2025 - 2030

Medical Device Design And Development Services Market Summary

The changing landscape of the medical device industry drives the medical device design and development market. Furthermore, increasing complexity and miniaturization of medical devices are significantly accelerating the growth of the global medical device design and development services market. As devices become more compact, multifunctional, and embedded with advanced digital capabilities, original equipment manufacturers (OEMs) increasingly turn to specialized design and engineering service providers to overcome technical, regulatory, and manufacturing challenges. For instance, wearable and implantable medical devices such as Abbott’s FreeStyle Libre continuous glucose monitor and Medtronic’s Micra leadless pacemaker demonstrate the trend toward extreme miniaturization. Such devices require highly specialized design expertise in microelectronics, biocompatibility, and low-power wireless communication. Traditional in-house R&D teams often lack the multidisciplinary capabilities to develop such sophisticated devices, thereby accelerating demand toward outsourcing service providers with expertise in microfluidics, micro-electromechanical systems (MEMS), and nanomaterials.

Stringent regulatory and compliance requirements are a critical growth driver in the global medical device design and development services market. With rising complexities in device technologies and increasing patient safety concerns, regulatory bodies worldwide are imposing rigorous standards to enhance device efficacy and safety. This stringent regulatory environment forces manufacturers to partner with specialized design and development service providers capable of managing the complex compliance requirements, thereby driving market growth. For instance, the U.S. Food and Drug Administration (FDA) implements comprehensive regulations such as the Quality System Regulation (QSR) under 21 CFR Part 820, which mandates stringent design controls, risk management, and validation protocols throughout the product lifecycle. Compliance with these requirements requires advanced design capabilities and thorough documentation, driving demand for expert external design and development partners.

Opportunity Analysis

The global medical device design and development landscape is undergoing a seismic shift driven by the convergence of engineering innovation, clinical demand, and demographic necessity. With over 1 billion people globally projected to be aged 60 or older by 2030 (WHO), there is surging demand for devices tailored to aging-related conditions like cardiovascular disease, osteoarthritis, and diabetes.

Similarly, the proliferation of connected devices through the Internet of Medical Things (IoMT) is pushing design firms to integrate wireless modules, embedded systems, and secure firmware from the early design phase. Regulatory frameworks such as IEC 62366 and ISO 14971 are now mandating usability engineering and formal risk management, creating a niche for specialized outsourced design services. Technological enablers like 3D printing and AI-driven design optimization are no longer optional; they are expected. This confluence is creating a multi-dimensional opportunity for service providers who can offer not just prototyping and CAD services, but also regulatory documentation, simulation testing, and human factor validation aligned with clinical practice.

Technological Advancements

The medical device design and development landscape is undergoing a significant transformation driven by emerging technologies such as artificial intelligence (AI), the Internet of Medical Things (IoMT), additive manufacturing (3D printing), and advanced materials. AI is enabling predictive modeling and faster prototyping by using machine learning algorithms to simulate product performance and optimize device parameters. This reduces time-to-market and improves design precision, especially for complex diagnostic or therapeutic devices. Moreover, AI-powered image analysis and real-time patient monitoring features are becoming core elements in device functionality, particularly in radiology and cardiology.

Pricing Analysis

Pricing in the medical device design and development services market is highly variable and influenced by the complexity of the device, regulatory pathway, scope of services, geographic location of the development firm, and stage of the development cycle. Design services are typically structured around milestones such as concept development, human factors engineering, prototyping, verification & validation (V&V), and regulatory documentation. Costs can range from $50,000 to $500,000+ per phase, depending on whether the project involves simple disposables (e.g., catheters, syringes) or high-risk devices like implantable or smart diagnostics.

Services Insights

The designing and engineering segment held the largest revenue share of over 38.47% in 2024. Design and engineering firms have proved their abilities by meeting stringent regulatory requirements, even when the project is complex, diverse, and demanding. Moreover, the pressure to reduce costs, increasing competition, rising demand from emerging economies, and technological advancements are prompting device makers to consider outsourcing design and engineering operations. Such factors are anticipated to drive the segment.

In addition, the machining segment is anticipated to witness lucrative growth over the forecast period. The growing demand for miniaturized and complex devices is a potential key driver for segment’s growth. The ability to machine complex materials in compliance with regulatory specifications and technological advancements in medical machining, such as laser micromachining, computerized Numerical Control (CNC), and machining of micro-precision medical components, is expected to further fuel the machining market.

Medical Devices Insights

The drug delivery devices segment held the largest revenue share of over 16.30% in 2024. The segment’s growth is driven by increasing demand for advanced drug delivery solutions, rising expectations for more effective and patient-friendly therapies, cost efficiencies for both individuals and healthcare systems, and the rapid pace of technological innovation in device development. Moreover, continuous innovation in novel drug delivery devices with ease-of-use, sustainability, and safety concerns for patients and healthcare providers across various treatments has fueled the segment's growth. As a result, devices such as autoinjectors, transdermal patches, and infusion pumps have grown strongly in the past few years.

In addition, the POC diagnostic equipment segment is expected to witness the fastest growth over the forecast period. Point of Care (POC) device provides rapid, reliable, fit-for-purpose test results at the point of need and pose unique design challenges. Furthermore, POC diagnostic equipment design provides an accurate result while ensuring the integrity of the specimen sample. This has led to the increasing adoption of rapid diagnostic tests. In addition, stringent regulations, and technological advancements are expected to boost the growth of POC diagnostic equipment within the medical device design and development services market.

Therapeutic Area Insights

The diagnostic segment captured a considerable share in 2024. Innovations in imaging technologies, point-of-care devices, and molecular diagnostics have driven significant investments in design and development. The increasing prevalence of chronic diseases and the need for early and accurate diagnosis continue to fuel growth. Companies are focusing on developing user-friendly, portable, and rapid diagnostic devices, further expanding the market.

In addition, the cardiovascular segment is expected to witness considerable growth over the forecast period. Cardiovascular devices contribute to advancements in treating heart failure, heart disease, arrhythmia, and other cardiac conditions. The growth of the segment is due to a rise in product pipelines and continuous upgradation of cardiovascular devices. Growing emphasis on high technology-oriented, price-sensitive, and quality competitive new device approvals accelerates the demand for robust devices.

End Use Insights

The medical device companies segment dominated the market in 2024. The segment’s growth can be attributed to the increasing demand for quality medical device products globally. Besides, the rising aging population and prevalence of diseases have surged research in medical device design & development. In addition, medical device development firms are leading innovations by adopting the latest technology trends such as miniaturization, portability, enhanced reliability, and connectivity. The overall outlook for design services is strong, owing to trends towards advanced manufacturing technologies, components, and automation techniques.

The biotechnology companies’ segment is expected to witness considerable growth over the forecast period. Recent trends have shown a vast migration in medical devices with significant advancements in diagnosis & treatment. Besides, the related and broad field of medical devices in biotechnology companies includes developing healthcare products & procedures that diagnose, treat, or prevent disease by adding pharmaceuticals or biologics. With the rich pipeline for medical devices and increased sales, the segment is expected to witness significant growth.

Regional Insights

North America Medical Device Design And Development Services Market Trends

The North America medical device design and development services market is expected to witness growth at a CAGR of 13.46% from 2025 to 2030. This can be attributed to the presence of established manufacturing companies and increasing innovation for high-quality products. In addition, many medical device companies, & biotechnology companies have shifted their focus to manufacturing service providers to efficiently handle the increasing volume of medical devices. This has led to a rising demand for the medical device design & development services market.

U.S. Medical Device Design And Development Services Market Trends

The medical device design and development services market in the U.S. is driven by well-established healthcare infrastructure, growing medical device outsourcing services, and rising R&D investments.

Europe Medical Device Design And Development Services Market Trends

The medical device design and development services market in Europe is expected to grow significantly due to increasing advanced technologies and the need for services to enhance the performance, & safety of new as well as existing medical devices.

The medical device design and development services market in Germany is anticipated to grow over the forecast period, owing to growing focus on owing to growing demand for medical device outsourcing and increased emphasis on quality is expected to further boost the demand for the market.

The medical device design and development services market in the UK is anticipated to grow over the forecast period. The high healthcare spending and rapidly evolving demand for medical devices contribute to the growing medical device design and development services in this region.

The medical device design and development services market in France is anticipated to grow over the forecast period. Supportive government policies and funding programs encourage R&D activities, boosting demand for outsourced design and development services. Collaboration between research institutions and industry players also accelerates product innovation. Increasing chronic disease prevalence and aging demographics create steady demand for advanced medical solutions.

Asia Pacific Medical Device Design And Development Services Market Trends

Asia Pacific medical device design and development services market dominated with the largest revenue share of around 42.0% in 2023. The region's high share is mainly due to the changing business model of medical device outsourcing and R&D activities. The region has a strong cost-efficiency offered by medical device design and development companies in countries such as India and China, contributing to its prominence in this field.

Moreover, growing demand for various advanced medical devices, favorable pricing, and rising local manufacturing boost the market need, fostering innovation & technological expertise within the region. Furthermore, low-cost manufacturing, a wide spectrum of complex & evolving medical device regulatory requirements, and developed manufacturing infrastructure for medical device design & development services drive the market.

The medical device design and development services market in China is expected to grow over the forecast period due to rapid technological advancements, growing demand for new & cost-effective medical devices, and high healthcare expenditure.

The medical device design and development services market in Japan is expected to grow over the forecast period due to the established healthcare infrastructure and increasing adoption of novel technologies that enhance the efficiency of medical devices.

The medical device design and development services market in India is anticipated to grow at the fastest CAGR over the forecast period, owing to favorable government funding to accelerate new product development, and favored destinations for manufacturing services drive the market.

Key Medical Device Design And Development Services Insights

The major players operating across the market are focused on adopting inorganic strategic initiatives such as mergers, partnerships, acquisitions, etc. The prominent strategies adopted by companies are service launches, mergers & acquisitions/joint ventures, mergers, partnerships & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge, driving market growth. Hence, increasing adoption of inorganic strategic initiatives is highly anticipated to boost the market share of prominent players operating across the market.

Recent Developments

• In November 2024, StarFish Medical acquired Omnica Corporation, a Southern California-based medical device design and engineering firm. This acquisition aims to expand StarFish Medical's presence in California, a major hub for medical device innovation, and enhance its capabilities in designing and developing complex medical products, including disposables, diagnostic products, and surgical devices.

• In November 2024, Planet Innovation partnered with Quantum-Si to develop and manufacture the Proteus proteomics platform and the Platinum Pro instrument. Planet Innovation aimed to bring Proteus to market within two years. Both companies emphasized accelerating innovation and making proteomics more accessible to improve human health.

• In May 2023, DeviceLab reported a strategic partnership with Nouslogic Telehealth, Inc. to accelerate the developing and marketing of next-generation wireless medical devices and remote healthcare solutions.

Medical Device Design And Development Services Market Report Scope

Global Medical Device Design And Development Services Market Report Segmentation:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global medical device design and development services market report based on services, medical devices, therapeutic area, end use and region.

• Services Outlook (Revenue, USD Million, 2018 - 2030)

  • Designing & Engineering

  • Machining

  • Molding

  • Packaging

• Medical Devices Outlook (Revenue, USD Million, 2018 - 2030)

  • Cardiovascular devices

    • Ventricular Assist Devices

    • Total Artificial Hearts

    • Pacemakers

    • Implantable Cardioverter Defibrillators (ICDs)

    • Cardiac Loop Recorders

    • Holter Monitors

    • Event Monitors

    • ECMO Systems

    • Consumables

  • POC diagnostic equipment

    • Blood glucose monitor

    • Blood analyzer

    • Blood pressure monitor

    • Pregnancy test kit

    • Infectious diseases testing

    • Hb1Ac testing

    • Coagulation testing Kit

    • Cardiac markers test

    • Thyroid stimulating hormone test

    • Others

  • Drug delivery devices

    • Autoinjectors

    • Infusion Pumps

    • Prefilled Syringes

    • Inhalers

    • Nebulizers

    • Nasal Spray

    • Intrauterine Devices (IUDs)

    • Transdermal Patches

  • Orthopedic devices

    • Prosthetics

    • Orthopedic Navigation Systems

    • Others

  • Dental devices

  • Surgical devices

    • Surgical Robots

    • Others

  • Imagining devices

    • X-Ray

    • MRI Scanners

    • Ultrasound

    • CT Scanners

    • Nuclear Imaging Scanners

  • Sleep & respiratory devices

    • Positive Airway Pressure (PAP) Devices

    • Ventilators

    • Oxygen Concentrators

    • Others

  • Ophthalmology devices

    • Fundus Cameras

    • Slit Lamps

    • Optical Coherence Tomography

    • Corneal Topography Systems

    • Others

  • Endoscopy

  • Diabetes care

  • Cochlear implants

    • Bionic Ear

    • Bionic Eye

  • Neurostimulators

    • Spinal Cord Stimulators

    • Deep Brain Stimulators

    • Others

  • Others

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Cardiovascular

  • Diagnostic

  • Others

• End use Outlook (Revenue, USD Million, 2018 - 2030)

  • Medical Device Companies

  • Biotechnology Companies

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait