Two technicians working in a laboratory or electronics workshop. In the foreground, a man wearing a white lab coat, red baseball cap, and glasses is seated at a workbench, using a tool to work on an electronic device. The bench is cluttered with various instruments, tools, and equipment. In the background, another technician in a white lab coat is standing and working at a separate station under a bright task light. The environment is organized and technical, indicating detailed assembly or testing work.

New Product Introduction

Develop a product that’s ready for manufacturing and commercial launch

Prepare to launch.

Transform your vision into a safe, functional product that meets a defined market need.

From initial design to the first manufacturing run, StarFish Medical employs cutting-edge new product introduction (NPI) strategies to deliver products that truly serve patients and clinicians. By performing all activities in-house, we ensure a streamlined, lower-risk process when transitioning to full production. Our unwavering focus on cost control, resource allocation, and overall efficiency guarantees consistency, positively impacting cost, timelines, and quality. With StarFish Medical, you can confidently navigate the complexities of product design and development, knowing that our expertise and dedication will help you succeed.

Michael Baker

Michael Baker

CEO
Otoharmonics Corporation

“I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.”

Ian Maclean

Ian Maclean

Project Manager
Koven Technology Canada

"I commend you for your vision in looking well ahead to regulatory and contract assembly issues, as well as a decision to concurrently develop key prototypes. This ultimately led to a successful design concept. All initial design requirements were satisfied."

Erik Henne

Erik Henne

Vice President of Research and Development
Uptake Medical

“StarFish in one word? “Boutique”, that really means “Bespoke”. We are ourselves a boutique medical device company. We are very focused on single product platform. We are not a giant diversified company, but we have important things happening here and the size and scale of StarFish matches our size and scale.”

What is New Product Introduction for Commercialization?

New Product Introduction / NPI is a comprehensive activity that spans the entire medical device design, development, and validation process to prepare for commercial-volume manufacturing. Both a process and a plan, NPI typically begins in the design stage and may continue through the first production run. Think of NPI as a crucial bridge to manufacturing, ensuring a smooth transition from concept to market-ready product.

Why Do I Need NPI?

Manufacturability of a device is often overlooked and can be a blind spot for development teams. Preparing a device for commercialization involves developing a supply chain, qualifying vendors, sourcing parts, and preparing for regulatory clearance/approval. All these activities take time, but they are essential for successful commercialization.

NPI and product development teams work together to ensure engineers have everything they need to consistently and reliably reproduce the prototype. By introducing the concept of manufacturability at the right time during product development, medical device companies can avoid costly mistakes downstream.

Medical device innovators that leverage NPI move their products through to first production runs with fewer delays and missteps—missteps that could lead to usability or quality issues. By following design for manufacturing (DFM) principles, NPI leads to lower costs and faster time to market. Without NPI, a medical device may reach manufacturing with a design that isn’t suitable for repeatable processes, resulting in costly redesigns and extended timelines. With consistent NPI processes, the focus is on manufacturability, traceability, audit readiness, risk management, and patient safety, all of which are essential for a market-ready product.

How StarFish Medical Digs Deeper into Commercialization

When you partner with us, our dedicated New Product Introduction / NPI team works closely with your team throughout the development process. Our experts approach product design and development with a manufacturing mindset, ensuring efficient commercialization and swift problem-solving. By integrating our deep knowledge and experience, we help streamline the transition from concept to market-ready product, minimizing risks and maximizing success.

Innovative Commercialization Outcomes for Our Clients

Medical device innovators partner with us to overcome commercialization challenges and bring breakthrough products to market. Here are a few examples of how our new product introduction / NPI-driven approach delivers real-world results.

Emergency Room Ventilators

We designed and built a certified ventilator within a 6-month timeframe as a response to the pandemic. The ventilator is easy to use, manufacture, and can be used in emergency situations.

Photo biomodulation for treatment of ocular disease

We developed an instrument for non-invasive treatment of ocular disease. This instrument is commercially available, and we support ongoing manufacturing of the product on the market.

Ultrasound for Fatty Liver Disease

Built a console and probe for non-invasive assessment of fatty liver tissue, offering a cost-effective alternative to MRI.

Why Companies Choose StarFish Medical

new product introduction

A Controlled and Compliant Manufacturing Process

Our manufacturing facility is ISO 13485 certified and compliant with FDA Quality System Regulations (CFR 820).

new product introduction

Your Milestones, Our Mission

We align our deliverables with your milestones, whether for preclinical trials, clinical trials, or fundraising rounds.

new product introduction

Design for Seamless Manufacturing

Our design-for-manufacturing process ensures your product is ready for manufacturing and assembly, with support for clinical trials and transfers to contract manufacturers.

new product introduction

Multiple Services under One Roof

StarFish has the people, processes, and facilities to take your medical device or diagnostic from concept to commercial manufacturing. Start with consulting to clarify the value stream and continue through to quality and regulatory support. We provide engineering, human factors and usability testing, and low-volume manufacturing in house.

new product introduction

Rapid Prototyping and Product Builds

Whether you need a prototype to prove to investors that your technology works, a device ready for clinical trials, or a product for transfer to large-scale manufacturing, we’ll get you there fast, with zero compromises to quality.

new product introduction

Agile Program Management

Our approach combines agile project management with scientific methods to meet your clinical objectives. Proven processes and a rigorous quality management system (QMS) are embedded in everything we do.

Explore Our Other Services

Illustration of a pencil and ruler

Product Design & Development

Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.

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Quality Assurance & Regulatory Affairs

We help you navigate complex regulatory landscapes to achieve commercial success. Explore our integrated approach to quality and regulatory services.

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Ready to explore how New Product Introduction / NPI services can enhance your product development?

Speak with an Expert