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
CEOOtoharmonics 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
Project ManagerKoven 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
Vice President of Research and DevelopmentUptake 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.
NPI Use Case
A medical device start-up needed a prototype to advance clinical studies and secure its next funding round. By leveraging commercialization activities based on NPI processes, the start-up was able to deliver a functional, usable prototype suitable for large-scale manufacturing.
Thanks to its development partner’s refined and validated processes at each stage, and strategic sourcing to secure components, the start-up conserved costs, ultimately leading to a more attractive exit value.
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Commercialization Case Studies
Winnipeg Ventilator 2.0
StarFish Medical led a consortium for the Government of Canada to create a ventilator at the start of the COVID-19 pandemic. StarFish overcame supply chain shortages to design and engineer a Health Canada-approved product in six months. See How
IMRIS Intraoperative MRI
[blurb TK] See How
Endra Thermo Acoustic Enhanced Ultrasound (TAEUS™)
[blurb TK design transfer/build] See How
How StarFish Medical Digs Deeper into Commercialization
Why Companies choose StarFish Medical
You’re assured a controlled, compliant manufacturing process.
Our manufacturing facility is ISO 13485 certified and compliant with FDA Quality System Regulations (CFR 820).
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.
We use an agile approach to manage complex programs.
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.
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.
6 Phases of NPI
NPI involves several incremental stages that result in a final product. While the specifics vary, you can expect your project to include the following phases.
1
Solidify the Plan
- Establish NPI team
- Identify resources and requirements to complete the product concept
- Set deadlines and clear expectations
- Go over Service Level Agreements (SLAs)
- Define team roles
2
Determine Feasibility
- Model concept in CAD
- Create process flow diagram for every product development stage
- Evaluate design concept and marketability using a Design for Manufacturing test
- Make go/no-go decision on design using an engineering verification test.
3
Develop the Product
- Create and evaluate working of product design.
- Test the prototypes with beta users as needed.
- Set up and evaluate the production space.
- Begin gathering resources for manufacturing, including material forecasting and shipments.
- Perform a gate review with the NPI team evaluating the practical and financial details of the manufacturing plan as well as the timeline.
4
Run Pre-Production Test
- Freeze engineering and design.
- Prepare molds and tools needed to manufacture product.
- Begin ordering materials and other resources. Perform product validation test run to ensure smooth production before fabricating on a larger scale
5
Manufacture the Product
- Manufacture final product.
- Perform frequent quality control tests every batch.
- Introduce product to market.
6
Evaluate the Results
- 30-60 days after first production run, evaluate NPI process and notes improvement areas for next production run or NPI process.
Explore Our Other Services
Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.
We help you navigate complex regulatory landscapes to achieve commercial success. Explore our integrated approach to quality and regulatory services.
Related Resources
Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.
Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.
Ready to explore how NPI can enhance your product development?