By Sean Fenske, Editor-in-Chief
 
Research and development is where the magic happens. It’s when an idea, napkin sketch, or passing thought can be transformed into a working medical device that helps address the needs of physicians or be used to treat patients. Without creative minds constantly working hard to solve problems or innovate through challenges, technology stagnates and new therapies can’t be used for those who need them.
 
Unfortunately, while medical device OEMs are regularly trying to come up with new ideas for better treatments, they aren’t always manufacturing experts. As such, they can have a fantastic concept, but may not know how best to produce it cost effectively. With this in mind, some service partners exist to help tackle these roadblocks and lend a hand in the name of innovation. Resonetics is one such company.
 
To explain exactly how his company is aiding the development of cutting-edge medtech, Kevin Hartke, chief technology officer at Resonetics, took time to address several questions around the firm’s Lightspeed Labs. He also shares his thoughts on why the organization puts so much value on engineer-to-engineer communication.
 
Sean Fenske: What is the Lightspeed Lab and how does it support R&D programs?
 
Kevin Hartke: Our Lightspeed Lab is a group of more than 150 engineers, machinists, and technicians deploying dedicated, state-of-the-art equipment to provide quick-turn prototyping solutions for the medtech customer. Resonetics has a total of ten Lightspeed Lab locations with technical specializations including:
 

• Semi-Finished Materials—Precision stainless steel tube, precious metal marker bands, and nitinol wire
• Laser Processing—Laser cutting, laser welding, laser drilling, and 3D laser ablation
• Nitinol Processing—Swiss machining, centerless grinding, laser cutting, heat setting, and electropolishing
• Metal Fabrication—CNC machining, Swiss machining, centerless grinding, and photochemical machining
• Microfluidics—Roll-to-roll laser/die cutting, automated layer stacking, reagent application, and packaging
• Sensors—Fiber optic and electromechanical
• Batteries—Implantable primary and rechargeable

 
Each Lightspeed Lab supports R&D programs by working closely with the customer to fabricate their most challenging components and sub-assemblies. The team is accustomed to working from concept to a delivered prototype in one to two weeks and iterating quickly until the implant and/or delivery system is performing optimally. The Lightspeed Lab supports concentrated development through a lab day, which includes the customer on-site iterating through concepts in real time with coordinated testing. Resonetics also has a dedicated project team for handling complex multi-site projects that require the support of more than one Lightspeed Lab.
 
After the feasibility phase is completed, the next step is a pre-production phase, which involves low- to mid-volume part fabrication. This phase also includes the initiation of our production readiness process (PReP), which is a phase gate approach to transferring projects to production. The PReP process includes the quality engineering and manufacturing engineering teams to support a successful transition. The final phase of the project is production, where the project is managed by our operations team for the duration of the product’s lifecycle.
 
Fenske: What have you done differently than other companies with the Lightspeed Lab? What have been the keys to success?
 
Hartke: Resonetics has been refining the Lightspeed Lab model for the past eight years and has expanded our technical offering with each new acquisition. A key success factor is a dedicated team of problem solvers that have the time and equipment to generate innovative solutions. We believe in the importance of engineer-to-engineer communication and collaborate with our customers to find the right manufacturing solution based on their project needs. In addition to the dedicated resources, Resonetics has an added advantage in fabricating much of its own capital equipment, which ensures the Lightspeed Labs always have state-of-the-art tools.
 
Fenske: You mention the importance of engineer-to-engineer communication. Can you go into more detail on how this drives innovation and reduces the development timeline?
 
Hartke: Product development cycles are continuously being compressed to shorten the time to market and reduce R&D costs. Connecting our customers directly with their engineering counterpart in the Lightspeed Lab enables the most efficient feedback loop for iterating on a new concept. The Lightspeed Lab team is trained in customer service and continuously coached on how to optimize customer communication. The team is supported by a talented group of account managers and business development professionals that stay focused on the business aspects of the customer relationship. This combination keeps the Lightspeed Lab team focused on solving technical problems.
 
Fenske: What are some of the current challenges you’re seeing in the industry and what are you doing to address them?
 
Hartke: The medtech market is continually pushing the prototype and manufacturing envelope with device trends including:
 

• Miniaturization—Making delivery systems and implants smaller enables treatment therapies with less trauma. This trend also addresses complex diseases for customers in the neurovascular, ophthalmology, and similar markets.
• Complex Sub-Assemblies—As the complexity of therapies increases, the trend of more complex delivery systems follows. These complexities include lower profiles (thinner walls), higher deployment forces, biomimetic mechanical properties, and advanced materials.
• Sensors—As devices go deeper into the body, there is a follow-on requirement to provide spatial and force feedback to the physician. Advanced imaging techniques have assisted on the spatial feedback, but the addition of sensors is required to assist with force feedback.
• Design Support—Assisting R&D engineers with design support is a growing need as manufacturing technologies advance.

 
Resonetics is addressing these trends through its Advanced Technology and Agile Product Development Groups. The Advanced Technology Group is working on next generation capabilities that will support the trends of miniaturization, complex sub-assemblies, sensors, and others. The Agile Product Development team supports customers by designing next generation medical devices and incorporating advanced manufacturing capabilities.
 
Fenske: What are you working on for the future? How do you see the Lightspeed Lab changing to continue to meet the needs of the industry?
 
Hartke: Beyond the technology advancements previously described, we are working on developing the next generation of the Lightspeed Lab model with a focus on increasing speed, improving the customer experience, and optimizing cross-technology integration. We are focused on further improving our quote turnaround time, while also giving our customers different methods through which to engage and communicate with our team. We recently launched a Connect with an Expert tool that helps quickly connect a customer to the right Lightspeed Lab expert who can support their project. We are committed to enabling the success of our medtech customers and take great pride in helping them develop innovations for patients every day.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Hartke: Resonetics is a global leader in advanced engineering, prototyping, product development, and micro-manufacturing. If you have an idea, concept, prototype, or production part we can help with, please use the Connect with an Expert tool available on our website to connect with the right Lightspeed Lab engineer based on your project needs. Our team also excels with the most challenging manufacturing problems, so if you’re struggling to get a device or component made, let our engineers help develop the best manufacturing process.
 
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