Medical-device startups face three main challenges: limited resources, limited expertise, and tight timelines. Developing a new medical device involves several complex steps, from concept design to regulatory approval. Many startups look for ways to make the process more efficient and manageable.
Outsourcing engineering support is a practice that has become common in the medical device industry. This article explains what medical device outsourcing means and how it is used. The focus is on engineering support for startups and how this approach has changed over time.
What Is Medical Device Outsourcing?
Medical device outsourcing refers to hiring external companies to handle specific engineering and technical services for medical device development. Unlike general business outsourcing that might include administrative tasks, medical device outsourcing focuses on specialized engineering work like product design, prototyping, software development, testing, and manufacturing support. The term ‘contract engineering’ is sometimes used as a synonym, but throughout this article, ‘medical device outsourcing’ will be used as the primary term.
This type of medical product outsourcing typically includes services like risk analysis, regulatory documentation, and compliance guidance. Companies that provide these services usually have teams with knowledge of medical technology and regulatory requirements.
The scope of outsourced services has grown as medical device companies face more complex requirements. Today, outsourcing partners can support projects from early design concepts through manufacturing transfer and regulatory submissions.
Common terms in this field include:
- Contract engineering: Hiring a team to complete specific engineering tasks
- Design transfer: Moving a product design into manufacturing
- Regulatory consulting: Support for FDA or international standards compliance
Why Startups Benefit From Outsourced Engineering
Medical device startups typically operate with limited budgets and small teams. Outsourcing engineering tasks addresses these challenges in several ways, especially by providing specialized capabilities on demand and optimizing resource allocation.
Access To Specialized Talent
Outsourcing gives startups access to engineers with experience in mechanical design, electrical systems, software development, and systems integration. These professionals often have direct experience with medical device projects and specialized roles like regulatory specialists, test engineers, and design verification experts.
Some specialized skills commonly accessed through outsourcing include:
- Firmware development for embedded systems
- Biocompatibility assessment
- Usability engineering
- Risk management analysis
Many startups cannot afford full-time specialists in every discipline, so outsourcing provides expertise as needed for specific project phases.
Reduced Operational Costs
Outsourcing eliminates recruitment and training costs while reducing overhead expenses like office space, equipment, and employee benefits. Startups can adjust support levels based on project phases rather than maintaining fixed team sizes throughout development. Outsourcing can reduce engineering and development costs by 20–30% compared to building a full in-house team.
This approach converts fixed costs like salaries into variable costs that only occur when services are delivered. A typical comparison shows in-house teams require significant upfront investment in recruitment, office space, and equipment, while outsourced engineering operates on pay-per-project or hourly models with minimal overhead. As a benchmark, outsourcing can help shorten development timelines to 12–18 months, especially for devices requiring rapid prototyping and regulatory preparation.
Outsourcing removes recruitment and training costs. It also cuts overhead such as office space, equipment, and employee benefits.
- Recruitment and training costs are eliminated.
- Overhead expenses, such as office space, equipment, and employee benefits, are reduced.
This approach converts fixed costs like salaries into variable costs that only occur when services are delivered. A typical comparison shows in-house teams require significant upfront investment in recruitment, office space, and equipment, while outsourced engineering operates on pay-per-project or hourly models with minimal overhead.Deloitte 2024 MedTech Outlook
Faster Development Timelines
Outsourcing can accelerate product development by enabling parallel work streams. Engineering partners often have established processes, templates, and documentation that streamline tasks like design reviews and regulatory submissions.
Experience with regulatory pathways like FDA 510(k) or CE Mark enables faster preparation of required documents. Some startups have reduced development timelines from over two years to 12-18 months by leveraging outsourced teams for both technical work and regulatory support.
Outsourcing reduces development timelines to 12–18 months[1].
Ensuring Quality And Regulatory Compliance
Quality and compliance are essential in medical device development. Products that interact with the human body or support healthcare must meet strict safety and effectiveness standards. Outsourcing partners help startups meet these requirements through experience with industry regulations and established processes.
ISO 13485 And QMS Standards
ISO 13485 is an international standard for QMS in the medical device industry that aligns with MDR requirements. We refer to this as the core framework for medical device outsourcing, sometimes called contract engineering, to ensure product quality and regulatory compliance.
When evaluating outsourcing partners, ISO 13485 certification indicates their processes align with global industry expectations. Partners with established QMS frameworks can support startups that may not have their own systems yet.
Key QMS components to look for include:
- Documented design controls: Formal procedures for managing design changes
- Supplier management: Systems for evaluating and monitoring vendors
- Change management: Processes for controlling modifications to designs or procedures
- Corrective actions: Methods for addressing and preventing quality issues
Documentation And Traceability
Medical device development requires detailed documentation at every stage. Outsourcing partners maintain design history files (DHF), which record how a device was designed, developed, and tested. These files provide evidence that the device meets safety and performance requirements.
Traceability connects every part of the device’s design and manufacturing process to its requirements and test results. This allows clear tracking of changes, decisions, and verification activities throughout development.
Risk Management
Risk management is a structured process to identify, evaluate, and control potential hazards related to medical devices. Outsourcing partners often follow ISO 14971, the standard for risk management in medical device development.
Effective risk management links directly to regulatory approval, as agencies like the FDA require clear evidence of risk analysis and mitigation strategies.
How To Select The Right Outsourcing Partner
Selecting an outsourcing partner involves evaluating several key areas that determine whether they can support a startup’s technical, regulatory, and business requirements.
Technical Expertise
Technical expertise refers to a partner’s ability to deliver engineering solutions that match specific medical device project requirements. Assessing capabilities involves reviewing portfolios of past projects, especially those involving similar device types or technologies.
Questions to evaluate technical expertise:
- What types of devices has your team developed recently?
- Can you show examples of projects similar to ours?
- How do you approach problem-solving in medical device development?
Regulatory Knowledge
Regulatory knowledge is essential for navigating approval processes in different markets. Requirements vary by region – FDA regulations in the United States differ from European Union Medical Device Regulation (MDR) in Europe. Understanding these differences matters for startups planning multi-market entry.
Key regulatory credentials include:
- FDA experience: 510(k), De Novo, or PMA submissions
- International knowledge: EU MDR and CE Marking processes
- Standards expertise: ISO 13485 and ISO 14971 implementation
- Global experience: Multi-country regulatory strategies
Communication And Project Management
Effective communication includes regular updates, clear project management methods, and collaboration tools like shared document platforms or project dashboards. Cultural fit and aligned working styles contribute to successful partnerships.
Communication warning signs include delayed updates, lack of transparency in project status, inconsistent documentation, or difficulty accessing project records.
Key Strategies For Managing The Outsourced Process
Working with outsourced engineering teams requires clear planning and ongoing management to keep projects organized and on track.
Define Project Milestones
Project milestones are specific points that mark completion of key tasks or development phases. Each milestone has measurable criteria indicating when work is finished, with acceptance criteria describing standards the delivered work must meet.
Essential milestones in medical device development include:
- Initial concept and requirements definition
- Product design finalization and design freeze
- Prototype fabrication and initial testing
- Design verification and validation
- Regulatory submission preparation
- Manufacturing transfer readiness
Maintain Clear Communication
Effective communication relies on regular updates and structured reporting. Meetings occur at set intervals to review progress, discuss issues, and plan next steps. Reporting structures outline information-sharing responsibilities, while escalation paths clarify problem resolution processes.
Common communication tools include email for formal updates, video conferencing for meetings, project management platforms for task tracking, and shared document repositories for technical files.
Track Performance Metrics
Key performance indicators (KPIs) measure progress and quality in outsourced projects. Establishing baseline expectations helps all parties understand expected results.
Important metrics include on-time milestone delivery, defect density in deliverables, change request resolution time, test coverage of requirements, and communication response times.
Scaling Globally With Medical Design Outsourcing
Medical design outsourcing can support international market entry by providing access to partners with global regulatory expertise, supply chain connections, and local market knowledge.
Regulatory expertise varies by region because medical devices follow different approval processes worldwide. The FDA has distinct requirements, while the European Union uses the MDR framework. Countries like China and Japan have separate certification agencies and documentation requirements.
The EU MDR full enforcement date is 2028 after the 2023 amendment.
Supply chain connections matter for international expansion, which often involves manufacturers, distributors, and logistics providers across multiple regions. Outsourcing partners may have established relationships supporting efficient component sourcing, prototype shipment, and finished product distribution.
Key markets have unique considerations:
- United States: FDA approval processes and cybersecurity documentation
- European Union: MDR compliance, CE Marking, and notified body engagement
- China: NMPA registration and local testing requirements
- Japan: PMDA approval and biocompatibility testing
Partnering For Long-Term Success
Sustainable outsourcing relationships often begin with project-based work and develop into strategic partnerships. When startups and partners collaborate across multiple projects, they build understanding of technical requirements, communication styles, and shared expectations.
Strategic partnerships involve continuous support beyond specific development phases. This may include joint planning for future products, post-market engineering updates, or scaling support as businesses expand. Over time, outsourcing partners may act as extensions of startup teams, contributing technical leadership and regulatory experience across product lifecycles.
A65 Consulting approaches partnerships by focusing on alignment with client goals and timelines. The team integrates with client organizations, offering both technical execution and project leadership as needed. For startups interested in exploring engineering support, proposals can be requested at A65 Consulting.
Conclusion
Outsourcing in medical device development offers significant cost and time advantages. Contact our team to discuss how your startup can benefit from these efficiencies.
Frequently Asked Questions About Medical Device Outsourcing
How can startups protect intellectual property when outsourcing medical device engineering?
Confidentiality agreements and clear IP ownership clauses in contracts define who owns inventions and protect sensitive information. Some companies limit confidential data sharing to only what each project phase requires.
What does outsourced medical device engineering typically cost for startups?
Costs usually include design and development fees, regulatory support, prototyping expenses, and project management, with structures varying between hourly rates, milestone-based payments, or fixed prices for defined scopes.MDDI Medical Device Outsourcing 2024 Costs
How long do outsourced medical device projects take from concept to market?
Timeline varies based on device complexity, regulatory pathway, and testing requirements. Typical development costs range from $500K to $2M, and timelines usually span 12–18 months, depending on risk classification and submission pathway.
Can medical device startups outsource only specific engineering phases?
Most outsourcing partners offer modular services, allowing startups to contract specific phases like concept development, prototyping, testing, or manufacturing transfer while managing other functions internally.