What should I expect working with Boyd Biomedical?

We've created a simple and easy to understand Customer Journey for our partners - so that you know exactly what to expect when you work with us.

1. INFORMATION GATHERING

2. PROPOSAL & NEGOTIATION

3. PROOF OF PRINCIPLE

4. PRE-VALIDATION

5. VERIFICATION & VALIDATION

6. ON-BOARDING

7. COMMERCIAL ENGAGEMENT

INFORMATION GATHERING

Almost all of our customers start working with Boyd Technologies somewhere in the design phase of their product development life cycle. As such, projects come to us in various forms of readiness for verification and validation, and eventually, commercial production.

In order to appropriately identify the scope of work that needs to be done, we begin with a robust information-gathering effort. During the information gathering stage of our journey, we try to gather as much existing information about you and your product as we can. This information is captured in our New Project Form, which you can fill out here. 

Before starting the form, please gather the following information. 

• Product Samples
• Product Description
• Project Timeline & Critical Milestones
• Three Year Forecast & Target Transfer Price
• Regulatory Requirements (Device Classification, GMP Requirements, Sterilization, Etc.)
• Part Specifications & Quality Requirements (Including testing and inspection requirements)
• Engineering Drawings
• Raw Materials (Bill of materials and supplier specifications)
• Packaging Specifications (final fill pouches or containers, cartons, cases)
• Label Requirements (Product and packaging)

PROPOSAL & NEGOTIATION

As soon as the Information Gathering stage is complete, we can begin our process of creating a proposal for you. This takes approximately one or two weeks, depending on the complexity of the project and various inputs we need to gather from third parties, such as quotes for testing, raw materials, and packaging. Following that, we will craft a proposal for you that lays out your project scope and budget. Below are a few examples of our proposals. 

Proof of Principle 

Verification & Validation

Manufacturing

Once you have reviewed the proposal and decided to move forward with Boyd Technologies, we will ask for an initial Purchase Order to begin our work. In some cases, we also execute a Manufacturing Services Agreement, which further clarifies the terms of our partnership.

At this point, we will ask for your initial purchase order to initiate the start of the project. Once we receive the purchase order, we will schedule a project kick-off call with you.

PROOF OF PRINCIPLE

Our commercial engagements begin with the Proof of Principle stage. During this stage, we prepare our projects to move into our formal design control phases: Pre-Validation, and Verification and Validation, which will occur after Proof of Principle.

During Proof of Principle, we focus on two areas - material sourcing and product design. We use an iterative process to determine the inputs that will impact product form and function. This process is customer-centric, and it varies in both time and complexity based on each product and application.

PRE-VALIDATION

Design control begins during our Pre-Validation stage. During this stage, we will establish the operating parameters we will use for the product's Verification & Validation. This work is accomplished through three types of production trials - Process Design, Edge of Failure, and Design of Experiment.

The results of our Pre-Validation work are important inputs into our design control documentation, which includes work instructions, part specifications and drawings, risk assessments (FMEA), verification and validation protocols, and a validation master plan. The result of Pre-Validation is a product that meets both form and functionality requirements and is properly designed for manufacturability.

All projects in the Pre-Validation stage are equipped with

• assigned program lead
• weekly conference call
• weekly program reporting

Process Design

During our Process Design trials, we determine the process design for commercial production.

Edge of Failure (EOF)

After Process Design is completed, we will conduct EOF trials. During our EOF trails, we will determine the minimum and maximum values of operating parameters with specified materials, including but not limited to tension, speed, and heat.

Design of Experiment (DOE)

After EOF is completed, we will conduct DOE trials. During our DOE trials, we will test the process input parameters and their interactions in order to optimize output. We will also test and inspect product requirements that will be used in regulatory filings such as seal strength, bio-compatibility, accelerated aging, moisture-vapor transmission rate, wear time, etc.

VERIFICATION & VALIDATION

After verification is complete, we will begin validation, which is the final stage of product development. During this stage, we will validate any new equipment we have installed, as well as the tolerances of all manufacturing equipment, and finally, the ability of our process and equipment to produce the product consistently. This work is conducted through qualification trials - Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Installation Qualification (IQ)

During IQ, we exhibit that new equipment is working correctly and able to produce the desired product.

Operational Qualification (OQ)

During OQ, we test all tolerances of our manufacturing equipment with 95% confidence and 90% reliability. We challenge the upper and lower limits on our process parameters using minimum lot sizes of 32 and sample sizes of 29.

Performance Qualification (PQ)

During PQ, we validate that the defined process will consistently produce acceptable product under normal operating conditions. We will manufacture three production runs to show consistency based on ASQ sampling tables. We consider a production run either a defined lot size or one full day of production.

ONBOARDING

We transfer products to our commercial team through the onboarding stage, which begins during our Performance Qualification (PQ) - the final stage of Validation. 

We begin our onboarding process with a kick-off call. During this call, we walk you through our way of working and introductions to our support team. This includes information on Order Fulfillment as well as opening Support Tickets (Customer Support, QA, etc.).

Following our kick-off call, your Point of Contact (POC) will stay in regular contact in order to ensure that our commercial engagement is now going smoothly. Eventually, your POC will transition into recurring business review meetings that typically occur once or twice a calendar year.

COMMERCIAL ENGAGEMENT

Once our onboarding is complete, and our commercial engagement is underway, we aim to continuously deliver value for years to come and fulfill our mission to Advance Health Care Together. A critical component of our mission is that we always act in the interest of long term partnerships. We do this by placing our customers in the center of everything we do with customer-centric marketing, sales, and service solutions.

 

                                                           

 

Marketing: Resources, Technology Solutions, Customer Marketing & Advocacy

We believe in delivering value to our customers at every stage of our engagement. We do this by providing relevant resources, technology solutions, and pursuing customer advocacy initiatives throughout our relationship. 

Sales: New Business Development, Next Generation Product Development, Networking & Partnership

We excel at understanding our customer's journey. Our goal is to meet our customers where they are in that journey weather that be early-stage product development, next-generation product development, or scale down manufacturing for a mature product.  

Service: Order Fulfillment & Support, Product Life Cycle Management, QA & Regulatory Support

Ultimately, we believe our work together should be a seamless experience - whether we are supporting ongoing commercial production, various phases of product development, or quality and regulatory work.  We use modern tools to facilitate this work, like our online project management tool and order fulfillment system.