Strategy
Market Research
Market research services help you gain insights into your target market and users of your medical device. Whether you are developing a new device, improving an existing one, or launching it in a new market, you need market research to understand the needs, preferences, and behaviors of your potential customers and users. We will help you identify the most important and most unaddressed opportunities for your device.
Our market research services are tailored to the specific needs and challenges of the medical device industry. We help you design and conduct market research that provides you with actionable intelligence to guide your decision making and strategy.
This is a critical first step in the design process: it is the foundation for determining design inputs.
Product Positioning
Product positioning helps you define how you want your medical device to be perceived by your target market and how it stands out from other similar products in the market. It helps you communicate your unique value proposition and the benefits that your device offers to your customers and users.
We offer product positioning services tailored to the specific needs and challenges of the medical device industry. We can help you craft a product positioning statement that identifies your target market, category, benefit, reason to believe, and point of difference. We also help you align your marketing mix, such as pricing, distribution, and promotion strategies, with your product positioning.
Design
Design Planning
Design planning is the roadmap for your project. We will help you make sure your design plans are complete and achievable so you can avoid repeating work and wasting time. We can help:
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Determine your project stages,
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Plan your verification and validation strategy,
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Ensure that the proper resources are aligned to achieve the design goals, and
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Put a documentation plan in place to ensure that the design outputs are traceable to the design inputs so you are audit-ready
Project Management
Once your project has been planned, you need someone to ensure that it is executed correctly, within budget, and on time. Elliot has years of experience as a project manager and can help meet this need or augment your existing resources.
Mechanical Design (MCAD)
We create designs which satisfy the design input requirements for your project. We specialize in plastic parts which will be manufactured using injection molding, vacuum forming, 3D printing, and/or CNC machining. We can also design sheet metal enclosures and solid aluminum parts. For larger, more complex projects with diverse materials, we work with our design partners to achieve the results you need.
We use Autodesk Fusion360 for our MCAD and ECAD work. We can import from and export to a variety of file formats, if needed. We can provide you with quick-turn 3D printed prototypes by leveraging our in-house capabilities.
Electrical Design (ECAD)
Our vision is to be a one-stop shop for your electromechanical projects. On the ECAD side of things, we can take your project from schematic design and component selection to a manufactured PCB. We specialize in analog design and signal processing. We are familiar with AVR MCUs. For projects with niche requirements or more complex firmware, we work with our design partners to achieve the results you need.
We use Autodesk Fusion360 for our MCAD and ECAD work.
Custom Fixtures for Testing or Production
Sometimes the process of verification requires data gathering that is too labor intensive for humans to perform. We can design custom fixtures to automate data collection for verification. Also, when the design has been transferred to manufacturing, we can create fixtures to streamline or automate production processes such as assembly and component inspection.
We can also assist you with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the fixture we design.
Design Reviews
Of course we will participate in any design reviews associated with work we perform. If we were not involved with the design work, however, we are ready and willing to participate in your design reviews as an independent consultant who can offer a fresh perspective and unbiased feedback.
If you are a small company, it may be difficult to satisfy the ISO and FDA requirements to have someone without 'direct responsibility' for the work to participate in the review. We can help with this.
Quality/Regulatory
Quality Management System Improvements or Full Builds
If you are a startup company or a small to midsize company with a new product that is a medical device, the requirement to have a Quality Management System (QMS) that is compliant with 21 CFR 820 (US) and ISO 13485:2016 (most international markets) may come as a surprise to you. We can help you build a QMS that supports your market access goals and equips you to produce medical devices which are safe and effective. Please do not wait to take this step! From the very beginning your product design must be managed and documented according to your QMS.
If you are a more established company and already have a QMS, but it is not very compatible with your existing workflows or you could use help improving it to resolve audit findings, we are able to help you.
Internal Audits
'How effective is your internal audit program?'
If your answer to the question above is 'What is that?' or 'Not very', we can help. FDA and ISO require regular independent audits of your QMS by someone who is not directly involved with each area under audit. These audits should help your company maintain compliance with your written procedures and identify possible problem areas before they impact the product realization process.
Product Risk Management
Product risk management, per ISO 14971:2019, is the:
“systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk”
We can help you apply the standard for risk management to your product to help you ensure safety and performance throughout its entire lifecycle.
Verification Protocol Writing and Execution
We can help write, and if desired execute, verification protocols (including sample size determination) to ensure that your device design outputs meet the input requirements.
US and Canada Market Access
We can assist with any of the following:
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Device classification (US and Canada)
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Labeling, including US FDA UDI requirements
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FDA registration and 510k submission (US)
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MDSAP Certification, including helping you meet the unique requirements of the CFR (US) and CMDR (Canada)
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MDL license application (Canada)
For more complex regulatory projects or for access to other markets, we work with our expert partners to achieve the marketing authorization you need.
Production
Design for Manufacture
We work to ensure that your medical device can be manufactured efficiently and reliably, while meeting the functional and regulatory requirements. We consider the manufacturing constraints and variability of your chosen process, material, and design, and optimizing them to reduce costs, risks, and time-to-market.
Whether you are using traditional methods such as CNC machining or injection molding, or innovative technologies such as additive manufacturing, we can help you achieve the best results for your medical device project.
Process Improvement
We can help optimize your manufacturing workflows and eliminate waste, errors, and inefficiencies. We can analyze your current processes and identify areas for improvement to achieve higher quality, greater speed, or lower cost.
We can measure the impact of changes we make on your production performance and profitability and assist with validation. We can help you with research, planning, testing, monitoring, and more to suit your specific needs and goals. Contact us today to find out how we can help you with your process improvement needs.
Process Automation