Medical Device and In-Vitro
Diagnostics Development
AVS provides lifecycle support in quality, regulatory, commissioning, qualification, and validation
Concept Development
Medical device development follows a well-established path. Many of these steps overlap with each other as scientists invent, refine, and test the devices. Typically, the development process begins when researchers see an unmet medical need. Then, they create a concept or an idea for a new device. From there, researchers build a “proof of concept,” a document that outlines the steps needed to determine whether the concept is workable. Many times, concepts are not practical. The concepts that do show promise move to the later stages of development.
Plan
A medical device development plan typically includes the following steps:
- Device discovery and concept
- Preclinical research-prototype
- Pathway to approval
- FDA device review
- FDA post-market device safety monitoring
A clinical development plan is a subpart of a clinical evaluation plan which aims at the devices which are going for clinical evaluation or the devices undergoing clinical investigations in the future.
Design/Build
Design/Build phase involves detailed design and engineering to transform the initial idea into a functional prototype. Engineers work closely with designers and clinicians to create detailed design specifications, focusing on functionality and usability. Medical device prototyping is a crucial part of design and development. Initial prototypes are developed and subjected to rigorous testing to evaluate their performance, safety, and durability. This phase also includes the development of manufacturing processes. Engineers design the methods that will be used to produce the device, ensuring they are efficient, scalable, and capable of maintaining high-quality standards.
Commissioning, Qualification & Validation (CQV)
Design validation is a testing process by which you prove (“validate”) that the device you’ve built works for the end user as intended. FDA (21 CFR 820.3) states that design validation is “establishing by objective evidence that device specifications conform with user needs and intended use(s).”
This includes:
- Establishing that device specifications conform with user needs and intended use.
- Testing the entire system (finished product) under real-world conditions.
- Ensuring that the device fulfills its intended use and meets user needs.
- Confirming that design outputs meet design inputs.
- Reviewing design documents, conducting inspections, and performing bench testing.
Design/Transfer
Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such as, transitioning from internal development to contract manufacturing for increased volume, moving from R&D to formal production, changing manufacturing locations, outsourcing to global facilities, and shifting from manual to automated production processes.
The medical device design transfer process is essential as it ensures validated devices can be consistently manufactured at scale, meeting regulatory standards, and maintaining safety. It facilitates seamless integration between R&D and manufacturing, ensuring efficient production and timely market entry of innovative medical products.
Commercial Production
Commercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product. It involves key processes like CNC machining, 3D printing, injection molding, and casting. This also includes important factors like shipment, validation of marketing plans by market introduction and implement processes to capture complaints, feedback and how this information will be treated.
Services
Medical Devices / In Vitro Diagnostic Services
- Agency Submissions: IDE, HCE, Master Files, etc.
- Batch Review and Disposition
- CE Mark/MDD/IVDD Risk AssessmentCFR Parts 11, 50, 56, 801, 803, 807, 812, 820
- Develop and execute validation protocols and prepared the reports
- Develop and implement preventative maintenance program
- Develop Risk Management Plan, and conduct Hazard Analysis, FMECA, and FTA
- EC 60601, 60812, 31010, 62304 EU MDR/IVDR Regulatory Strategy & Compliance
- Establish quality systems for device manufacturing
- FDA Meeting Preparation & Engagement
- FDA-483 &/or Warning Letter Response & Remediation
- Health Authority Response & Remediation Audits, Assessments & Gap Analyses
- Implement corrective actions (CAPA) based upon FDA warning letter citations
- Information Technology: CSV, SDLC, Part 11 Compliance
- Inspection Support & Facilitation Mock GXP Regulatory Inspections
- Internal audit support per QSRs, identification of system deficiencies and assistance with corrective actions
- ISO 9001, ISO 13485, ISO 14155, ISO 14971 21 Certifications
- Lab, clinical, and scientific operations support
- Lab instrument, software systems/network validation
- Pre-Approval Inspection (PAI) Readiness Preparation & Planning
- Prepare and implement QSR training program for combination products
- Product Development 510(k)/PMA Submissions
- Provide regulatory support for 510k filing
- QSR Auditing: In-Vitro Diagnostic, Medical Device, ISO 13485, MDSAP/Qualification/For Cause, etc.
- Quality Management Systems
- Sponsor/CRO/CMO Training & Readiness
- Strategy development for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
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QC
Lab Study
The client is a leading San Francisco based biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases such as targeted antibodies for cancer.
AVS assisted our client in upgrading their manufacturing space from a Biosafety Level 1 GMP facility to a Level 2 GMP facility. We were able to complete the entire project on schedule and within budget. Moreover, our documentation efforts to demonstrate full traceability was deemed appropriate by our client’s quality assurance team.
We were able to support our client throughout this entire transition process, from gap analysis to final equipment installation. Because of our efforts, this pharmaceutical manufacturer was able to manufacture medication with the lentivirus vector material. This collaboration allowed our client to focus on what they do best – develop medicines to help improve their target patient’s quality of life.
While re-visiting some protocol tests initially tested by the technician, we observed some anomalies in test results that were shown as “Passed”. Upon further investigation it was found that the technician did not detect that some barcode scanner cameras were installed upside down.
This was overlooked because the barcode scanner returned sets of values of 0's and 1's that can sometimes give identical results depending on the barcode being scanned. This was also overlooked because there were no sufficient tests to challenge the system.
A positive outcome was that important lessons learned were captured for the client. This led the QC laboratory team and Quality team to evaluate their business process to identify the gaps that allowed for unreliable test results.
This experience also helped the team have open discussions regarding team workload, and responsibilities they have to each other, to the company and ultimately to the patients.