When commercialising a new concept or device, why is it so important to partner with an expert for medical device design & development? Simply put; because a loosely defined and designed product cannot comply with regulatory needs and it will fail to deliver the user defined functionality and benefits.
There is so much more to consider when designing and developing a medical device than having an innovative idea and then ‘simply’ manufacturing a product. You must carefully evaluate needs, functional requirements, specifications, and more, all while assuring quality and managing risk. Safety is a priority in medical device design as it is a requirement to ensure that devices meet functionality, reliability and safety features.
Partnering with Mi3 on the journey to design & develop your device will ensure that every consideration is made from design planning and regulatory strategy to meeting end-user needs compliantly, cost effectively and ensuring patient safety.
Seven key steps can be identified in the process, along with the critical outputs an experienced contract manufacturing partner such as Mi3 will bring to the process.
1. Identification of Need
The idea for a new medical device typically comes from the discovery of an unmet need. Identification of need is only the first step in a series of complex processes required to bring a medical device to the market. If there is no or little need for the product then it is unlikely to succeed in the market. The more understanding of the need the more inputs can be created and enhance the product definition at this stage.
The Engineering team at Mi3 are experts in understanding plastic materials, geometrics and manufacturing technologies that allow for concept refinement and are able to advise further in this area.
2.Business Case and Commercialisation
Consideration of all the facets required to commercialise a new product is a complicated process and all these ultimately feed into the regulatory requirements for the regions of sale and the initial business case for realising the product.
Partnering with Mi3 will give you confidence that the business requirements for the product are factored into the design, development and manufacturing processes every step of the way to develop a robust business case to aid securing the vital funding required for commercialisation.
3.Device Classification
Medical device classification is based on the risk associated with the use and enforced by law. It is important to get the classification determined early in the process in order to understand the regulatory pathway and requirements. Typically device classification is agreed with your Notified Body.
With Mi3’s Quality Management Systems certified and audited to ISO 13485:2016 via MDSAP our experienced regulatory team can support you every step of this process including providing assistance around intended use, associated risks and proposed classification.
4.Discovery
This phase is for refining concepts and initial designing, prototyping, and iteration driven redesign. Developing working prototypes is a crucial part of the development process and depending on what the prototype is for, Mi3 can advise on the most suitable prototyping method and generate prototypes to support all stages of the D&D process.
5.Regulatory Requirements and Strategy
Medical devices are subject to regional and international standards. These regulatory requirements should be identified early on in the development process and reviewed periodically to ensure that any changes in the regulatory environment as well as any new scientific technologies are considered.
Regulatory compliance is critical so ensure you partner with a team that can provide comprehensive medical device consulting services to help remove the complexity that often arises across the regulatory landscape.
Mi3’s regulatory systems are constantly evolving alongside the ever changing medical device regulations to ensure compliance to the most stringent standards within the industry. We regularly celebrate zero non-conformance audits from Notified Bodies and successfully achieved MDSAP accreditation in July 2018. Mi3 can help you develop a regulatory strategy incorporating the specific regulatory requirements as well as the possible pathway(s) to take that is balanced, realistic and achievable to support your organisation’s mission and vision.
6.Testing, Verification and Validation
Verification and validation (V&V) of medical devices aims to ensure that the device is aligned with the voice of the customer and delivers the intended purpose. It also demonstrates whether all the requirements are being satisfied or not and are compliant with regulations.
Standardised V&V activities can streamline the manufacturing process as well as enhance the approval processes. Additionally, tests used for V&V activities also need to be validated (and often are transferred to QC for release of the product in routine manufacture).
This includes clinical and product safety testing, sterilisation considerations and primary packaging as well as overlapping with the manufacturing process development and process validations for manufacturing the product.
Mi3 can advise and perform all your V&V testing requirements, including the development and validation of new methods or adaptation of State of the Art Standards.
7.Risk Management and Post Market Surveillance
Every medical device manufacturer must have established risk management procedures in place, and those processes must be in compliance with ISO 14971. These requirements apply to all stages of medical device design and development, as well as the entire lifecycle of the device. Risk management activities should be aligned with all phases of D&D and post-market requirements.
Mi3 can support, advise and provide a comprehensive range of services in support of risk management and post market surveillance requirements.
In summary, medical device commercialisation is a complex process encompassing regulations, specifications, application requirements and end user needs. If a device lacks usability, market share will suffer, and if a device doesn’t meet regulatory guidelines, it won’t be approved for market at all. The team at Mi3 work closely with you to ensure your medical device, be it simple or complex, is designed and developed to meet the scope of its intended use and the needs of the end user in a cost effective and timely manner. Contact us today to your free initial consultation.
Mi3 Limited
www.mi-3.co.uk
Tel: +44(0)1254 678 398
