Medical Device Development
Design and Development
Verification and Validation
Without the benefit of experience, it is extremely difficult to foresee and plan for the potential complications in medical device development. Required activities may be missed and timelines unrealistic. Poor project management can drain funds and kill a project before it has had a chance at success.
Vestech Medical can take your device from the initial concept through all stages of device development to market delivery. Vestech Medical employs a defined strategy to ensure all required activities are appropriately performed and properly documented and aligns vendors with your specific goals to ensure that your device is compliant with the relevant standards and regulatory requirements. Our wealth of experience across various regulatory jurisdictions in combination with our proven processes can streamline the project pathway to ensure regulatory approval is achieved.
The Planning Phase is the first formal phase of product realisation. The planning documentation created at this stage ensures that the benefit of the project and scope are evaluated, and the resources required for each phase of the project are identified. Careful planning and risk-based decision making is essential at this early stage to ensure that the project is set up on the path to success.
Auditors will review planning documentation to check for its existence, compliance with the regulatory rules, and adequacy. Planning is the key starting point for a successful medical device development.
Key documentation created in this phase include:
- Regulatory Strategy
- Design and Development Plan
- Risk Management Plan
- Clinical Use and Safety Characteristics
- User Needs and Customer Requirements
- Applicable Standards and Guidance
Often start-ups and small sized companies outsource part of the operations to a design house, manufacturers, and/or sterilisers. The choice of suppliers are crucial decisions that have long-lasting implications throughout the product lifecycle, and lack of experience and exposure to these specialised fields increase the difficulty of making the best decision.
Vestech Medical’s extensive experience and exposure to all aspects of product development will provide you the expertise and network to initiate your project with the best chance for success.
Proof-of-concept prototypes are valuable for determining the feasibility of the device and its potential to meet the user and market needs. A tangible model of your device allows you to identify flaws that may have otherwise been overlooked and to make iterative modifications to the design which can then be tested in a more cost-effective manner. A prototype of your device offers the excitement of providing a first glimpse at the realisation of your innovation. It also aids potential investors in grasping the concept and providing promise for the final product.
Vestech Medical has a network of appropriate and cost-effective prototyping partners we can use to bring your idea to life.
During the Design and Development (D&D) phase, the product requirements are defined to ensure user needs and customer requirements and regulatory requirements will be met by the design. Risk management is a crucial activity at this stage. With an ISO 14971:2019 compliant risk management framework, Vestech Medical ensures that the risks related to the device are comprehensively captured to prioritise risk mitigation and safety. Risk management can be a confounding activity that is often performed incorrectly by those unfamiliar with the task. A poorly executed or poorly documented risk management puts the safety and efficacy of the device at risk and can leave you vulnerable to litigation in the post-market phase if your device fails out in the field.
At Vestech Medical, we have designed our processes to be adaptable to the complexity and risk of the device to ensure that the required activities and documentation is appropriate for your device classification in the desired regulatory jurisdictions. Our engineers have a wealth of experience across a range of products from surgical implants to syringes to provide you with confidence, including the development of Medical Device Software compliant to IEC 62304.
Following design and development, the Verification and Validation (V&V) phase is entered. V&V planning ensures all product requirements and user needs are verified or validated. This provides evidence that the product requirements are met, and that the device conforms with the intended use and user needs. V&V is performed on product that is representative of the final product for regulatory submission to demonstrate that the product that is going to market is safe and effective. This includes not only the device itself, but also its labelling and packaging.
During the V&V phase, confusion may arise surrounding the difference between verification and validation and which type of activity is required for each product requirement and user need. The V&V process can also become confounded by poor traceability between the chain of user needs and risk assessment leading to product requirements, which then lead to design outputs and the required V&V activity. This can lead to issues such as the device does not meet the intended use, the device is unsafe, or the device has not thoroughly been demonstrated to be safe and effective – situations that are undesirable and risks failure of regulatory approval.
The team at Vestech Medical has witnessed these complications in the past and seen the damage it can do to a project. Benefit from our wealth of experience and foresight to ensure that you avoid these potential pitfalls and have a smoother path to success.
The regulatory world can be difficult to navigate with convoluted regulations. The sheer volume of requirements and, on occasion, their lack of clear instruction, may make compliance appear as a daunting task. However, with the right knowledge and experience, the universal nature of regulations creates opportunities to streamline the approval process, including device classification, conformity assessment pathways, and the use of regulatory approvals in one jurisdiction to accelerate approval in another. Vestech Medical is well experienced in preparing documentation for regulatory submission and has repeatedly succeeded in gain approval for the Australian TGA, EU CE Marking, and US FDA 510k approvals. Vestech Medical will work diligently with you to achieve regulatory approval in a timely fashion.
Design transfer is the process of preparing for manufacture. It involves producing production specification and verification and validation of the manufacturing process. Design transfer activities ensures that the manufacturing process can produce product in alignment with design requirements and that it complies with applicable regulations governing the manufacturing of medical devices for commercialisation.
This is considered early in the project by Vestech Medical to ensure a streamlined transition to manufacturing of product that repeatedly and reliably meets product specifications and quality acceptance. Early consideration of manufacture can save time and cost at the design transfer phase.
As a parallel activity to the Design and Development phase, Vestech Medical integrates Design For Manufacture and Design For Regulatory into your product. Due to inexperience or simple oversight, these two activities are often left too late in the design process or sometimes missed entirely until it is too late. For example, we will look at packaging, sterilisation, and transportation design early in the project to ensure greater success at passing the Verification and Validation phase, whereas our competitors will just focus on manufacturing the medical device in isolation first. It is foresight like this, that will reduce your time to market and set you up for regulatory success.
Vestech Medical evaluates suppliers in the early stage of the project with consideration of their manufacturing scalability and quality control processes. This can prevent the need to source a new supplier as production increases post-market.
Depending on the jurisdiction, Design Transfer may be required to be completed prior to a regulatory submission to meet all regulatory requirements.