Engineering Healthcare Innovation: Top 10 Medical Device Design Firms

Behind many successful medical devices are design and engineering firms that provide the technical expertise, regulatory knowledge, and development capabilities necessary to bring innovative healthcare solutions to market.  

As products become more complex and regulations grow more stringent, especially as software and AI enter the medical device domain, selecting the right medical device design partner has become increasingly important. In addition to navigating complex and dynamic regulations, these firms must understand clinical workflows and environments. They should maintain deep knowledge of biocompatibility requirements, sterilization processes, quality management systems, designing for manufacturability, manufacturing transfer and manufacturing at scale.  

What Sets Industry Leading Medical Device Design Firms Apart 

Regulatory expertise is fundamental, with top firms maintaining teams of professionals, many of whom were previously employees of regulatory bodies, who specialize in device classification, risk management, clinical evaluation, global regulatory guidelines and changes, and regulatory submission processes. Top medical device design and engineering firms invest heavily in maintaining up-to-date knowledge of FDA regulations, ISO standards, and international compliance requirements across multiple classifications and global locations. This expertise is invaluable for avoiding costly delays and ensuring successful regulatory submissions. 

Broad therapeutic area experience is another distinguishing factor. Leading firms have successfully developed devices across multiple medical specialties, including cardiology, orthopedics, diagnostics, robotics, surgical instruments, and patient monitoring systems among other technologies. Diverse experiences enable them to apply best practices and innovative approaches across different applications. 

Design and engineering excellence, excellence that one can validate, is table stakes as well. During detailed design and development phases, leading firms provide mechanical engineering, electrical engineering, software development, and systems integration services. They conduct extensive testing and validation, including biocompatibility studies, performance testing, and human factors validation. Astute medical device design and engineering firms and their clients do well to incorporate human factors engineering (HFE) expertise, including recent HFE regulatory guidance and requirements throughout the process inclusive of the earliest iterations or prototypes. 

Manufacturing support has become increasingly important, with top firms offering everything from manufacturing feasibility consulting to high-speed prototyping and fast proof of concept services, supply chain management and controlled build support. This end-to-end capability ensures that devices can be manufactured at scale with consistent quality and regulatory compliance.  

Most importantly, leading firms have evolved beyond traditional design services to offer comprehensive solutions that span the entire product lifecycle, enabling clients to consolidate vendors and streamline development processes. They understand that successful medical device development requires seamless integration of research, industrial design, human factors, engineering, regulatory strategy, and manufacturing expertise—all working in concert to transform innovative concepts into commercially successful products. 

Partnering with the Right Medical Device Design Firm 

Selecting an appropriate medical device design partner requires careful evaluation of several critical factors: 

• Assess the firm’s experience within the therapeutic area of interest as regulatory requirements and technical challenges can vary significantly between different medical applications.  

• Confirm the firm’s track record of successful regulatory approvals, particularly with devices of similar complexity and risk classification. 

• Evaluate the breadth of services offered and whether the firm can support the entire development lifecycle or will require coordination with additional vendors.  

• Examine the firm's quality management system, regulatory certifications, and approach to risk management.  

• Take stock of the firm's manufacturing capabilities or partnerships to seamless transition from development to commercial production.  

• Consider cultural fit and communication style as medical device development projects typically require close collaboration over extended periods. 

The best partnerships are formed with firms that view themselves as true collaborators in the innovation process, bringing not just technical expertise but strategic guidance that increases the likelihood of commercial success, along with comprehensive concept to commercialization expertise that means you don’t have to stop to engage an external resource. They should also understand how your business or funding mechanisms work. If a regulatory submission unlocks follow-on funding, strategic sequencing of activities can increase the overall likelihood of success. Having knowledge required at any phase, for any insight, accelerates commercialization timelines, reducing cost and accelerating time to revenue. 

 In addition to navigating complex and dynamic regulations, these firms must understand clinical workflows and environments. They shouldmaintain deep knowledge of biocompatibility requirements, sterilization processes, and quality management systems.  

Partnering with the Right Medical Device Design Firm 

Selecting an appropriate medical device design partner requires careful evaluation of several critical factors: 

• Assess the firm’s experience within the therapeutic area of interest as regulatory requirements and technical challenges can vary significantly between different medical applications.  

• Confirm the firm’s track record of successful regulatory approvals, particularly with devices of similar complexity and risk classification. 

• Evaluate the breadth of services offered and whether the firm can support the entire development lifecycle or will require coordination with additional vendors.  

• Examine the firm's quality management system, regulatory certifications, and approach to risk management.  

• Take stock of the firm's manufacturing capabilities or partnerships to seamless transition from development to commercial production.  

• Consider cultural fit and communication style as medical device development projects typically require close collaboration over extended periods. 

The best partnerships are formed with firms that view themselves as true collaborators in the innovation process, bringing not just technical expertise but strategic guidance that increases the likelihood of commercial success, along with comprehensive concept to commercialization expertise that means you don’t have to stop to engage an external resource. Having knowledge required at any phase, for any insight, accelerates commercialization timelines, reducing cost and accelerating time to revenue. 

Top Medical Device Design Firms 

1. CLEIO
   With offices located in Montreal, Quebec, and Indianapolis, Indiana, CLEIO has established itself as a premier medical device design firm serving the North American market. With a team of more than 50 experts in strategy, design, and engineering, CLEIO supports clients from the early stages of product definition through to production. Their services include human factors engineering, user experience and user interface design, industrial design, mechanical engineering, electronic engineering, software development, embedded software development, and quality assurance.
   
   
2. Gilero 
   Based in Durham, North Carolina, Gilero is a contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. Founded in 2002, the firm began with a focus on single-use medical devices and has now become a one-stop shop for the design, development, and contract manufacturing of devices ranging from consumables to complex electromechanical drug delivery systems. In 2024, Gilero joined with Sanner Group, which operates seven facilities across Europe and Asia.
     
3. Veranex 
   With product design and engineering (PD&E) locations worldwide, Veranex distinguishes itself through a comprehensive, integrated approach refined over 35 years and across 1000+ programs. The firm is the industry’s first Innovation Contract Research Organization (iCRO) which unites all aspects of development, from initial design and market strategy supported by in house regulatory and quality services through preclinical, and clinical testing services. This integration of services eliminates the handoffs between separate vendors that can create delays and increase risk. Veranex’s model focuses on translating device concepts into robust, commercially successful products by leveraging diverse experience with the complex develppment challenges across all therapeautic areas. 
   
   
4. Cambridge Design Partnership
    With R&D facilities in the UK and US, Cambridge Design Partnership is a full-service product innovation firm with capabilities ranging from applied science, data science, and people-centered design to product engineering, quality and regulatory affairs, testing, and transfer to manufacture. Their systematic approach to product development has resulted in the creation of more than 500 patents and the delivery of over 2,000 projects across various therapeutic areas, including drug delivery systems, diagnostic devices, and surgical equipment. 
    
5. Integer
   Integer is one of the largest medical contract development and manufacturing organizations, offering comprehensive cardiac rhythm management, neuromodulation, and cardiovascular solutions. The company excels in creating complex components and class II and class III devices by leveraging its global presence, vertical integration, and extensive design and manufacturing capabilities to accelerate time to market. 
    
6. Design 1st 
   Located in Ontario, Canada, Design 1^st specializes in the development of technically-challenging useful and innovative products. Their cross-functional team customizes their approach and technologies to meet each client’s objectives, whether updating an existing product, developing a concept, or transforming an idea into a product. Design 1^st applies its proprietary, four-step Stage-Gate® process to help clients navigate from concept and detailed engineering to prototype, testing, and manufacturing setup. 
   
   
7. StarFish Medical 
   StarFish Medical has built a reputation for tackling complex medical device challenges by blending deep technical expertise, regulatory insight, and user-centered design. With over 25 years of experience and more than 200 professionals, StarFish Medical has been involved in 1000+ programs with a focus on diagnostic, drug delivery, and therapeutic devices. The firm also offers ISO-certified facilities for rapid prototyping, verification and validation testing, and pilot-scale manufacturing. 
   
   
8. Nocturnal Product Development
   Based in Durham, North Carolina, Nocturnal helps medical device companies develop class II and class III implantable devices and offers a unique milestone-based pricing model. The firm offers expertise in implantable and life-saving devices, which require hands-on experience across advanced disciplines such as ultra-low power hardware and software, biosignal acquisition, and hermetic packaging. Nocturnal also has a rich library of hardware designs, software code, and documentation templates that can help to jumpstart and de-risk projects. 
    
9. Paragon Medical
   With headquarters in Indiana and over a dozen locations worldwide, Paragon Medical offers comprehensive medical device development services with a strong focus on the manufacture of highly complex, multi-faceted medical components and products. Their current portfolio includes spinal surgical knives and related instruments, cases and trays, surgical instruments, implants, drug delivery, and soft tissue technologies and devices.
    
10. Sage Product Development
    Located in Foxboro, Massachusetts, Sage is led by seasoned engineers who are recognized as medical device design and development experts. They combine a high level of experience with a low overhead company structure to solve technical challenges and meet product development needs in an efficient and cost-effective manner. Sage is known for its design, development, and manufacture of surgical devices, implants and electromechanical assemblies and its deep knowledge of flexible endoscopy, minimally-invasive surgery, and catheter-based devices.
    
     

The Future of Medical Device Innovation 

As the medical device landscape grows more complex, the critical question for innovators is no longer just "Can you design our device?" but "Can you assess every risk to ensure our product achieves regulatory approval and market success?" 

An integrated partner like Veranex addresses this by strategically managing risks at every stage of development. This approach provides confidence to stakeholders and ensures the creation of a robust, reliable device poised for market success, ultimately transforming promising technologies into market-leading solutions. 

Ready to build a development strategy that prioritizes certainty and a clear path to market?