The Silicon Review
Medical devices save lives. The sooner you can get your medical device out to the market, the sooner it can help people. Medical device compliance is important to the success of every medical device manufacturer. Failing to achieve compliance will compromise your device’s future. Patients expect medical devices to be safe. Using medical devices should improve their health and even save their lives. That’s why proving medical device compliance is important. It guarantees patients that the device they are using is, in fact, safe.
Pathway NPI is a growing leader in Medical Device development and manufacturing. Theye serve the industry's leading innovators to deliver an efficient, single-source solution to commercializing products that will improve the healthcare market. Their FDA/ISO 13485: 2016 registered establishments is home to an industry leading Quality/Regulatory team focused on product excellence and efficient market clearance. The company provides right sized design, engineering, quality, regulatory, and GMP manufacturing services to create solutions that exceed industry standards.
Product Development for Medical Devices and Other Innovations
Pathway NPI believes no design is complete until it can be manufactured efficiently, repeatedly, and to meet top quality standards and regulations. They excel at the design and development of medical devices and other new products without ever compromising quality. Navigating the complex development process for a medical device requires comprehensive quality management. This journey, led by their team of experienced engineers, begins with creative conceptualization and design stages. Following these early stages of medical device development, the Pathway NPI team seamlessly guides clients through the regulatory and manufacturing phases.
The conceptual prototype phase is often fraught with stress; many of their clients come through the doors with more questions than answers. The Pathway NPI team has the experience to help companies of all sizes navigate the intricacies of initial ideation and risk analysis, in order to develop a viable proof of concept that checks off every box – without breaking the bank. They do this by working side-by-side with clients to educate them on the nuances of medical device design. For Pathway NPI, helping clients overcome technical challenges is a crucial focus in all they do. The company's extensive experience and resources allow them to tailor their services to meet the unique needs of the clients.
Quality Assurance for Medical Devices
Pathway NPI’s design team and quality assurance experts use their extensive knowledge to guide a product through the entire development life cycle, offering a strategic and customized approach to bring a medical device to market. As you design your viable medical device, the time comes to identify its intended use and move to the regulatory strategy phase. It is true — regulatory strategy can make or break the journey to FDA approval. This is why it is important to work closely with a team familiar with every potential hurdle. Please note that the Center for Devices and Radiological Health (CDRH) is the branch of the FDA that oversees the regulatory and quality assurance processes for the approval of medical devices.
Most medical device developers hire a consultant to review a proposed product, evaluate existing products in the FDA market, and deliver a summary report on a potential testing roadmap and market introduction strategy. The company's pproach is far more unified. Pathway NPI integrates design, regulatory strategy, and manufacturing processes to optimize the entire team’s efforts and deliver quick, effective solutions to overcome any challenges along the way. They are in the trenches with you, developing your crucial medical device technology for ultimate market success. This approach often shortens the overall FDA approval runway for their clients. While the exact timeline and regulatory requirements are product-dependent, the company is confident in their unique and agile product development approach, thanks in large part to their fully integrated quality control system.
Leadership | Pathway NPI
Arthur Deptala is a co-founder and Managing Partner of Pathway NPI. He has 20+ years of expertise in medical device development and manufacturing. A self-described “true-blue engineer,” his experience covers a diverse array of product types, including surgical instrumentation and robotics, patient-worn body sensors, and high-volume disposables.
Arthur oversees and directs a variety of projects at Pathway NPI, with a concerted focus on design for manufacturing (DFM) and manufacturing integration. Clients benefit from Arthur’s extensive experience in DFM to help transition proof-of-concept technologies into manufacturable, commercially viable product.
Jonas Cochran, is a co-founder and Managing Partner of Pathway NPI. With more than two decades of experience in medical device engineering, Jonas has an unparalleled breadth of knowledge in product and manufacturing engineering. He began his career developing specialty equipment for Welch Allyn, which included production test equipment and high-speed packaging, and oversaw the integration of these technologies into Welch Allyn’s FDA-registered manufacturing facilities.
At Pathway NPI, Jonas oversees design development for an array of technologies. In particular, he enjoys assisting clients with early-concept design and establishing efficient development strategies using a minimum viable product (MVP) approach. Jonas also provides strategic advising to Pathway NPI’s manufacturing management team, a role that benefits from his extensive experience in Six Sigma and lean manufacturing practices.