Your medical device contract manufacturing partner for your biomedical innovation.

Biomedical innovators often lack the specialized resources necessary to manufacture their products. They cannot compete without reliable product quality, competitive costs, and efficient time to market. We provide the capabilities and expertise to help them win.  

At Build by Boyd, we partner with biomedical innovators to manufacture complex, high-quality devices, on time and on budget—ultimately, providing them with a more successful build. 

We help you turn Just Might into Just Mighty.

Process Development & Validation

Manufacturing

Supply Chain Management

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We design and optimize manufacturing processes to ensure they can reliably and repeatedly produce devices. We will develop the process, including selecting equipment, tooling, and process methods. We will test the process, usually on a small scale, to identify and resolve any issues. Once the process is defined, we will perform a process validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). After process validation, when all testing, inspection, and documentation are completed, we will transfer the product into commercial manufacturing.

  • Tooling & Capital Equipment
  • Process Engineering
  • Manufacturing Transfer (IQ, OQ, PQ)

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Once a device is transferred into commercial manufacturing, we will begin regular production campaigns based on forecasts and distribution requirements. Production campaigns typically recur monthly or quarterly. Manufacturing is performed in controlled environments, adhering to our Quality Management System, which is certified to ISO 13485 and meets FDA requirements for medical device manufacturing. Inspection and testing protocols that have been defined will be implemented, and records of the process will be maintained to ensure traceability.  

  • Devices & Components
  • Liquid Media
  • Device Assembly
  • Kitting
  • Packaging

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Our supply chain management team will assist in selecting and managing suppliers of equipment, tooling, raw materials, components, and any necessary services. Once a device is transferred into commercial manufacturing, we typically assume all ongoing supply chain management responsibilities. We align our inventory management activities with demand forecasting and production scheduling to ensure a seamless and uninterrupted supply chain. We implement appropriate quality controls, risk management practices, and documentation procedures to ensure compliance with quality and regulatory requirements.

  • Supplier Management
  • Inventory Management
  • Distribution & Logistics

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Case Studies

Trusted engineering and operations leaders

 

Build by Boyd is a team of trusted process engineers, operations leaders, and supply chain experts. Our objective is to partner with biomedical companies to engineer and produce their innovations. To each client partnership, we bring a wealth of biomedical engineering and operations experience from within the biomedical industry. Here’s a quick glimpse at some of our work.

Philips Zoom!

Mobius® Essential

Remedy® DriGo-HP™

ZipThaw®

Erbi Breez™

Smileactives®

What’s the ROI on Better Manufacturing?

Better manufacturing drives measurable outcomes. Organizations that accomplish improved manufacturing enhance quality through better product reliability, achieve lower costs and a more competitive cost of goods sold, and accelerate time to market for product launches and future product iterations.

Trusted Partners

We partner with the best biomedical innovators in the world

 

Our partnerships lead to greater innovation and better health. We're proud of the work we do with our integrated design, build, launch growth platform.  

FREE ASSESSMENT

Build a Better Device

Get your free manufacturing assessment to help you understand where you are in the manufacturing process today, what gaps you need to fill, and the critical next steps you need to take. We start with a discovery call, and then we create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives. Our assessment is free - it requires no cost or commitment from you.

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Our Approach

 

Discovery

We begin by understanding where you are today, what you already have in place, and your future objectives. We accomplish this in one or two discovery meetings. 

 

Assessment

We create a written assessment summarizing where you are today and a high-level plan outlining our recommended steps to meet your future objectives.  

 

Statement of Work

We develop a detailed statement of work for the first phase of your project. The statement of work outlines the project timeline, deliverables, costs, and key milestones. 

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Your innovation Just Might change the world. But is your manufacturing up to the task? We help you turn Just Might into Just Mighty.