Developing a new, innovative medical device from concept to commercialization can be a very complex endeavor. Whether you’re outsourcing a proof-of-concept prototype or a full-phased engineering assignment, it’s crucial to select a partner that can meet all your device requirements.
To help you find the best partner to aid in the development process, ask yourself the following questions:
Technical Expertise & Relevant Experience
Does the company offer technical expertise and relevant experience? This might be the first, and most important question you ask when choosing a partner to develop your medical device. The company you choose should offer the right combination of services as well as employ engineers that have experience developing similar devices. Do your research and determine who you’d be working with directly. How many years of experience do they have? What type(s) of devices do they typically develop? Do they offer a new, innovative approach to your project? These are all important questions that should be answered to choose the best company to partner with.
Now that you have identified the company’s relevant experience, how do they manage their projects? From regulations to documentation and deadlines to budgets, it is essential to choose a company that can manage your project from start to finish. Does the company have the internal engineering capabilities to manage a full-phased project? A team of engineers with different backgrounds and expertise will offer a multidisciplinary approach giving you the best technology and process for your device.
Since each department offers its own set of obstacles, assigning a project lead to manage each function will be critical to your device’s success. The project lead should be knowledgeable in each department. They must understand the development process, as well as the necessary documentation and regulations one must follow to submit a device to the FDA or European Union (CE Mark). The designated project lead will be your point of contact for technical information. They will also assure your project stays on time and on budget.
Proven Development Process
The company has experienced engineers and offers a multidisciplinary team approach when developing a device. How many devices have they developed in the past? What is their process for bringing a device from concept to market? What milestones will need to be completed throughout the development process?
Choosing a company that has a practical and proven medical device development process is imperative. Ensure that the company has the necessary ISO certifications and executes their quality management system. Do they have a plan to address each design, development, and manufacturing activity? Be sure the company has a successful process implemented that controls design inputs, verification and validation plans, design reviews, and manufacturing transfers.
If you’re looking for the right company to manage the development of your device from concept to commercialization, on budget and on time, look no further. Via Biomedical has the technical expertise, project management experience and proven track record of success to meet all your design requirements. If you have questions or would like to begin a partnership, contact us today!