Cutting through the jargon of medical device development

NDA – Nondisclosure agreement

NDA is a term you will hear from us very early in the conversations we have with you. Confidentiality is key in all our conversations. We understand that not all (potential) clients have established IP protection and therefore, we ensure that we have the right documentation in place before any confidential discussions take place. For us, NDAs are two-way as we may also share confidential processes or concepts before you become a client to explain how we work and how we can optimise your route to market.

IP – Intellectual Property

As mentioned above, Intellectual Property (IP) is important and comes in many guises, from copyright to trade secrets and know-how to patents. Much of it is intangible, and can’t be formally ‘owned’ or protected, but protectable IP, such as patents and design rights, can be of huge commercial value in gaining competitive advantage. However, that value is only present if the patent(s) is applicable to the marketable product, and ideally as many competitive alternatives as possible. You can read more about IP in our blog: 5 things to consider when navigating Intellectual Property in product development.

TRL – Technology Readiness Level

Technology Readiness Levels (TRLs) indicate the maturity of the critical technology upon which your core IP or innovation is being built. Understanding the TRL of your project is important as it allows stakeholders to assess project status and track progress in a standardised way that’s independent of the particular scientific or technical area.

By assessing the maturity of your critical technology and identifying any gaps in your programme, you can better understand the necessary steps for an efficient and effective product development. This understanding will enable you to build a business plan around areas which require additional expertise and subsequent investment.

We have created a free Technology Readiness Level assessment tool that integrates the TRL scale with our product development roadmap and provides an index against which you can assess your programme. Your results will help you evaluate the maturity of your technology, product or process and identify areas that may need further investment to enable progression.

Get your score here

URS – User Requirement Specification

Often referred to as User Needs, Intended Uses, User Requirement Documents or Customer Requirement Documents, the ‘User Requirement Specification’ (URS) is a statement of the ‘end-user needs’, from their perspective, with respect to the product being developed. The URS describes what the product should do from the end-user’s perspective but does not describe how it should do it.  It should also not propose a design and must remain solution agnostic. The final design will be validated against the URS by the project owners. The URS needs to focus on two questions: “as the user, I want the product to…” and “what is the right product to make?”. It is imperative to keep these questions in mind throughout the entire development process.

PRS – Product Requirement Specification

In contrast to the URS, the Product Requirement Specification (PRS) is a technical statement of functional and performance requirements, with respect to the product being developed. The PRS describes what the product should do, from an engineering perspective. The PRS may define how the device should do it but does not detail the embodiment of the design and portrays what everyone on the project team are aiming to deliver, across the whole spectrum of the project. The final design will be verified against the PRS by the responsible project team members as defined. Often referred to as Design Input Requirements, the System Requirement Document, or the Engineering Requirement Specification, the PRS needs to focus on “what functional/performance target does the product need to achieve?” and “how will we make the product right?”.

RM – Risk Management

Risk management should form the backbone of product development, specifically within the MedTech sector, where use error, due to a lack of user insight and poor usability design, could have fatal consequences. It should be employed early in your development programme, so that any problems can be identified, factored in, and subsequently mitigated and tested for suitability. This includes gaining an understanding of reasonable ‘misuse’, which is often overlooked but is critical for the risk mitigation process and can be addressed through user testing. It is worth noting that the level of usability testing and human factors employed should be commensurate with the level of risk identified. There are also commercial benefits to risk analysis and mitigation. A demonstrably safe, intuitive, and effective product that has been developed with the user will likely have increased commercial success.

uFMEA – Use Failure Mode and Effects Analysis

Conducted as part of your usability or human factors tranche of development, your ‘use failure mode and effects analysis’ addresses any potential use errors of a device. Intrinsically linked to your risk management plan, but different to a design FMEA, your uFMEA analyses the expected ‘behaviour’ of a product when operated by the user, looks at how errors could occur and describes their potential severity and impact on the user and device itself. Your uFMEA should provide you with a detailed review of potential use risk, what is deemed acceptable and a checklist of areas to address in order to develop a safe and effective device. It is also worth noting that for many regulators (such as the FDA) uFMEA documentation is a necessary inclusion in the technical file submission and without it, the product will not receive regulatory approval.

dFMEA – Design Failure Mode and Effect Analysis

Not to be confused with uFMEA, ‘design failure mode and effect analysis’ is a methodical process which helps engineers identify new or existing risks associated with the product design and their potential impact. dFMEA is exclusively related to the design phase of a project. Identifying potential risks early in a development programme is crucial and a dFMEA will identify design functions, failure modes and outline actions required to mitigate any design-related risks. As with uFMEA, regulatory bodies will often require dFMEA documentation to show that a risk mitigation strategy has been established and the appropriate steps carried out.

UI – User Interface

The user interface is the part of your device through which the user interacts with, operates and controls the software. The UI of a device is incredibly important and can be the source of use-related issues, so it is crucial to understand the usability and conduct extensive user testing around this important design element. The UI needs to be clear, intuitive, easy to operate and understand, efficient and a pleasure to use. It has a huge impact on user experience (UX), as it is the primary conduit between the user and product. By understanding the user needs and requirements, as well as the use environment of the product, developers can design a UI which not only ensures effective and safe operation, but also delights the user.

IFU – Instructions for Use

Instructions for use also fall within the usability and human factors element of your design and are a comprehensive guide for the user, detailing clear and concise instructions for the product’s intended purpose, how the product should be operated and what the expected outcomes are. The IFU should also detail any precautions that should be taken when using the device. IFUs are far more common in the MedTech field, as all medical equipment, devices, and accessories sold for clinical use need to include an IFU. Through human factors engineering, you should know your audience thoroughly, understanding their language, the visuals needed to explain your product, their requirements, and their preferences, and your IFU should be tailored directly to this.

DFM – Design for manufacture

There is little point designing a product which looks amazing but cannot be manufactured due to cost, complexity of assembly, component scarcity or quality issues. Design for manufacture is an approach which mitigates this issue. The design approach includes early prototyping and iteration to ensure the product not only works as planned, but also any risks and issues that may arise through manufacture or use are identified and addressed. Understanding the manufacturing process is key and consideration must go into material choice, component availability (off the shelf or bespoke) and production automation. Many designers create a prototype of their product which simply could not be manufactured at scale. If volume production is a must, then DFM is a good approach to ensure the product can be made in large quantities. We work with a number of partners to ensure our clients can leverage the right supplier and/or manufacturer for their project, whilst ensuring the product is developed with assembly and build in mind.

FDA – Food and Drug Administration (USA)

The FDA is the regulatory body in the United States which is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices. FDA approval of a medical product (drug, device or biological) means the product’s safety and effectiveness have been reviewed by the FDA and the product’s known and potential benefits outweigh the known and potential risks. If the FDA grants an approval, it means the agency has determined the product is safe and effective for its intended use. For a medical device to be launched to market in the USA, it will need to receive FDA approval. In recent years, delays in medical device regulatory approval within the EU have prompted UK- and EU-based startups to prioritise approval from the FDA, a tactic which is increasingly being demanded by investors.

CE Mark – Conformité Européenne / European Conformity marking

CE marking is a product conformity marking that shows that the product meets all relevant EU requirements and has been assessed as such before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It also means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements in line with European health, safety & environmental protection legislation. CE Marked goods are allowed for sale on the EU single market and some markets outside the EU, such as the UK, Turkey and Switzerland. CE Marking also allows the free movement of products within the European market.

UKCA – UK Conformity Assessed

Effective from January 2021, UKCA marking is the mandatory conformity assessment for many goods to be launched onto the UK market only. Applicable to products which previously needed to be CE Marked, UKCA covers medical devices, electrical equipment, toys and machinery, amongst other goods. Many MedTech companies are not going down the UKCA route and opt to get their product CE Marked instead, as this allows access to the full European market in addition to the UK.

Navigating the complex development pathway on your route to market doesn’t have to be stressful. You can choose to partner with a consultancy who has trodden the path numerous times before. This is where we come in…not only do we understand the acronyms and where each fits into your journey, but we live and breathe them every day, so can guide you to product success. Read more about working with us here.

eg technology are a product design, engineering and development specialist based in Cambridge, UK. We provide an integrated solution for innovators requiring the expertise to bridge the gap between their idea and a market-ready product. eg works with organisations, from start-up to blue-chip, to deliver inspiring, marketable and industry-transforming products across MedTech, Lab and BioTech, VetCare, CleanTech, AgriTech, Consumer and Food/Drink Sectors. Specialising in electronics and software engineering, industrial and mechanical design, human factors, project management, technical due diligence and regulatory compliance, we know how to solve technical challenges and make things work. eg is an agile and adaptive development partner providing tailored project delivery, whilst minimising risk from concept through to transfer to manufacture in an ISO 13485 accredited framework.