In the rapidly evolving landscape of medical device design and development, one of the most important decisions that companies will face is whether to do product development in-house or contract the process to an outside firm. Bringing a new device to market is a complex lifecycle that demands expertise, precision, and adherence to rigorous regulatory standards. Unless you are a company with an established and experienced team of development resources, finding employees with the right expertise can be a time consuming process. Standing up entirely new teams can also entail more risk, compared to using a firm with years of experience and a good reputation. For smaller companies and start-ups, this often leaves contract design and development as the best choice for quickly bringing a product to market.
There are many different contract design and development companies in the industry. These companies range from small, focused firms, to development teams inside larger contract manufacturing organizations. When choosing a partner for your device, one of the first things you should do is look for someone that has expertise in the area you are working on. An implant is very different than a diagnostics device or delivery system. Your best chance of success in getting regulatory approval and having commercial success will be leveraging the experience of a team who has been down the same road with similar applications. This partner can bring a deep understanding of regulatory compliance, technological advancements, and industry standards for the field your device is focused on. The right partner can also bring credibility with investors when you need to raise additional capital.
Once you’re ready to start a project, it is best to break it up into phases. Start with concept and planning, or a small feasibility project. This will allow you to make sure the partner is the right fit and test out whether the initial concept for the device is worth pursuing, which serves to limit the upfront investment until you feel comfortable with the direction of the project. A well-executed planning phase also de-risks the program and provides a more complete picture of the total time and funding required to complete the project. Ultimately, this allows you to make a more significant investment in continued development with confidence as you move towards animal testing and eventually clinical trials.
In an industry where innovation and safety are paramount, partnering with the right contract product design and development company will help you navigate the complexities of medical product development successfully. Their expertise and experience will contribute to the creation of transformative medical devices that improve patient outcomes and revolutionize healthcare delivery.
AGILE Product Development at Resonetics
At Resonetics, we understand the importance of having focused expertise, especially related to contract product design and development services. We initially started our AGILE Product Development team with the acquisition of Distal Solutions in 2021. This innovative firm specialized in the design and development of catheter-based delivery systems and implants for interventional markets. We furthered our focused expertise with the acquisition of Agile MV in 2022. Agile MV was originally founded in 2010 by seasoned MedTech veterans, including some of the key personnel behind CryoCath. They brought industry-leading expertise in catheter-based devices that enable the precise delivery of energy, drug, and cell therapies directly to a target site within the body. Agile MV has garnered recognition in electrophysiology for its specialized expertise in cryo and pulsed field technologies.
Resonetics areas of expertise:
- Electrophysiology and Cryotherapy
- Interventional Catheter Delivery Systems
- Nitinol Implants
The goal of the AGILE product development team is to collaborate seamlessly with your team while striving to be flexible and attentive to the changing demands of your project. As your full-service partner, we can prepare the design documentation your project needs for regulatory approval and increase speed to market. Our AGILE Product Development team also works directly with Lightspeed Lab engineers to seamlessly integrate the latest advancements in processing capabilities and achieve a functional, efficient, and scalable solution for your product. We consider manufacturability and unit cost upfront to ensure targets are realized at launch. Our teams are strategically located in Westborough, MA, San Diego, CA and Montreal, Canada. You can contact our team directly at email@example.com.
Founded in 1987, Resonetics is a pioneer in advanced engineering, product development, prototyping, and manufacturing solutions for the MedTech and life sciences industry. The company’s four core business units are Interventional, Advanced Diagnostics, Minimally Invasive Surgery, and Embedded Technologies. Resonetics is a leader in laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics, sensor solutions, and medical power. With strategically located AGILE Product Development centers and Lightspeed Labs, Resonetics is committed to quality, speed, innovation, and a great customer experience. The company is ISO 13485:2016 certified with 14 facilities and more than 2,000 associates in the United States, Canada, Costa Rica, Israel, and Switzerland.
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