The medical device industry is at the forefront of innovation, constantly driving advancements in healthcare technology.
Valued at USD 518.46 billion in 2023, the industry is poised for significant growth, estimated to reach USD 542.21 billion in 2024.
However, designing and manufacturing these devices require precision, compliance with strict regulations, and a high level of expertise.
This is where contract engineering comes into play. It offers specialized services to bridge the gap between the concept and the final product.
We look into the essentials of contract engineering for medical devices, explore its benefits, and also look into some of its challenges.
What Is Contract Engineering?
Contract engineering refers to outsourcing specialized engineering services to third-party firms with expertise in specific fields. In the medical device industry, this approach enables companies to collaborate with experienced engineers and technical experts. These contract engineering specialists can design, develop, and even manufacture complex medical equipment.
External engineering teams work closely with medical device companies to meet industry standards.
Why is Contract Engineering Important for Medical Devices?
Access to Specialized Services
Medical devices, by design, are intricate. They require engineers with knowledge of biomechanics, material science, electronics, and software development. Companies that employ contract engineers often create multidisciplinary teams that are equipped to handle these challenges.
Faster Time to Market
Speed is critical in this competitive medical device market. Partnering with a contract engineering firm allows companies to gain pre-existing knowledge and proven methodology, which reduces the development time.
Cost Efficiency
Hiring an in-house specialist for every aspect of the development of a medical device can be costly. Contract engineering provides access to highly skilled teams on a project-by-project basis. The result is cost optimization without compromising on quality.
Key Stages of Contract Engineering for Medical Devices
The Concept
With a global market value of $70 billion in 2023, the medical device contract manufacturing industry is thriving. At the core of this expansion are contract engineers, who assist businesses in navigating the intricate world of design, development, and manufacturing.
No matter how inventive, all medical devices begin as a concept. Contract engineers put in a lot of effort to develop these concepts and make them a reality.
For example, a wearable health monitor concept may require input from materials and electronics experts.
The Designing and Prototyping
Once the core concept is solidified, engineers focus on detailed design and prototyping. This includes creating 3-D models and selecting materials. It also means building functional MVP. Advanced prototyping tools such as 3-D printing allow for quick testing.
Testing and Validation
Testing ensures that the device needs functional safety and regulatory standards. This stage involves performance testing and user evaluation. Basically, it is an analysis to identify and resolve any potential issue. Contract engineers often use simulations and physical testing to validate these designs.
Regulatory Approvals
Contract engineering firms assist in preparing documentation and conducting risk assessments. This ensures that the device complies with all the relevant standards and regulations.
Manufacturing Support
The global medical device outsourced manufacturing industry is experiencing rapid growth, projected to reach $29.3 billion by 2026. Once again, contract engineers are essential to this expansion because they help businesses with every stage of the product life cycle, from conception to the final production.
Challenges in Contract Engineering for Medical Devices
While contract engineering offers many benefits, it’s not without challenges. Understanding these can help medical device companies navigate partnerships effectively.
Finding the Right Partner
Not all engineering firms are equipped to handle medical device projects. Gener8 suggests that companies must check potential partners for the right technical guidance. It helps to hire a contract engineer with experience in similar projects, certifications, and a track record of success.
Intellectual Property Protection
Collaborating with an external company means sharing sensitive or classified information. A clear contract and non-disclosure agreement are essential to guard against any intellectual property issues.
Communication Barriers
Successful projects rely on clear and consistent communication. Differences in time zones and cultures can lead to misunderstandings. Establishing regular check-ins and using project management tools can minimize these risks.
Cost Issues
While contract engineering is cost-effective, poorly defined scopes or unexpected complexities can lead to budget issues. The solution is to set clear deliverables and milestones.
How Contract Engineering Drives Innovation
Contract engineering is not just about cost savings or efficiency. It is a driver of innovation. Collaboration with experts outside of the team helps medical device companies explore new technologies and design approaches.
Contract engineering offers a reliable path to success. It helps both startups looking to launch an innovative product and established companies seeking to optimize the development process.