Product Development – Early Stage

MediPath^TM Innovation Roadmap – Product Development – Early Stage

In the previous stages of the Medipath™ Innovation Roadmap we considered Innovation Strategy (Stage 1) and Opportunity Analysis (Stage 2), which are aimed at understanding the ‘fuzzy’ front end of innovation to a point at which the project has been de-risked to allow it to be progressed through a Go / No Go decision point and to enable further investment decisions to be made.

Stage 3 is designed to progress the technical development to a stage at which it can be evaluated and at which compliance with non-clinical regulatory requirements can be demonstrated. In addition, this stage involves developing the commercial business case for adoption; determination of the regulatory strategy ensuring that development is aligned to the quality management system; determination of the product labelling; and importantly, the generation of functional prototypes that are suitable for evaluation and testing.  In the section below each of these elements is considered in turn, with practical insights into the reasons why each of these steps is important.

Preliminary value proposition

This is essentially developing the business case for adoption and is about understanding the influencers in the procurement decisions and ensuring that both the product design and evidence meet the needs of all stakeholders (e.g. the patient, the healthcare professional (HCP) and the payer).  Although market research, human factor and voice of the customer analysis can feed into this process, the most powerful means of developing the value proposition is to identify the relevant quality indicators that the innovation can address. 

It is also important to monitor trends and general procurement policies such as the net zero and social value weighting for the NHS which means that companies should consider design for the environment in their design process and also develop carbon reduction plans. Examples include minimising packaging and consideration of the the advantages and disadvantages of reusable devices versus single-use devices.

The needs of many markets such as the US and the EU mirror those of the UK and as such the evidence generation plan and resultant clinical investigation and should be appropriate for gaining access in multiples geographies around the world. 

Initial Regulatory Strategy

The regulatory strategy essentially involves identifying and prioritising the target markets and ensuring that any compliance, technical documentation and clinical evidence requirements are sufficient for that market.

This includes aligning the innovation strategy with the outputs of the market analysis, along with an appraisal of the organisation’s current relationships and exposure to domestic and international markets, and taking into account cultural considerations and local clinical practice that may impact the attractiveness of specific markets.

There are also practicalities such as the evidence hurdles that might need to be overcome, which can be different for different regulatory jurisdictions.

For the UK market for example, having a medical device CE marked to the MDR 2017/745 would allow market access to at least 2030. However, there might be situations in which it would make sense for a company to gain UKCA approval for the UK market in the first instance, prior to EU or other market approval. However, the new UK Medical Device Regulations are sure to take effect in July 2025, in which the quality and quantity of data is likely to have similarities to the EU requirement, such as the need to comply with relevant General Safety and Performance Requirements (GSPRs).

For some companies the US market is attractive, and for some lower to medium risk devices, where predicates exist, rapid routes of approval such as the 510K route can be utilised, providing the device under evaluation is considered substantially equivalent to a predicate.  However, it is becoming more difficult, especially for differentiated devices, to demonstrate substantial equivalence, and for these devices there is the need to go down other market approval routes such as de novo or premarket approval (PMA), which can be expensive, time consuming and require large amounts of clinical data, ideally in US populations. Some caution is also needed in that having FDA approval does not necessary equate to market success as one still needs to sell the product and navigate the complex reimbursement processes of Medicare and the private insurers.

It should be noted that in the UK the government has announced their intention to recognise products approved in the US, Canada and Australia in addition to the EU. The timelines of and practicalities of these international recognition pathways were unknown, at the time of writing, but these developments will clearly feed into the regulatory strategy and the prioritisation of markets.

Design History File and QMS Development

For established companies with devices already on the market a quality management system (QMS) will already be established, and the principles of design control will likely be adhered to, and the design history file (DHF) will likely be used to document the design process.  For medical devices the standard QMS system is ISO 13485 (https://www.iso.org/standard/59752.html).

During the early-stage product development phase when test methodologies for verification and validation (and conformity to relevant GSPRs) are being identified or developed and therefore is a long window to launch, represents the ideal time to ensure that a fit for purpose QMS is implemented. 

In addition, it is imperative that risk management (ISO 14971) and other standards or common specifications related to the device or technology are identified at this stage, which will need to be adhered to and evidenced in the Technical File documentation.

This article in not intended to focus on the details of a QMS, but many providers now offer electronic QMS solutions that can accelerate the time and effort needed to develop a certified QMS system.

Product Claims and Labelling

Product claims and labelling is a key part of the early-stage product development.  The labelling is essentially the formal wording that will be on the instructions for use (IFU) and covers elements such as the product description, indications, intended purpose, intended users, indications for use, intended populations, key claims and benefits along with any warning or contradictions.  

This is one activity which all to commonly manufacturers leave to late and can result in mis interpretation of the product classification and importantly if not aligned to the evidence generation plan can result in clinical trials that fail to collect the right evidence to support the intended purpose or claims of the device.

The formal labelling is derived from the user needs analysis, definition of design outputs and related activities such as developing the value proposition. Additional insight can come from the labelling of competitor products, feedback from existing customers or sales teams, an evaluation of the clinical literature or from clinical guidelines such as those produced by NICE or professional bodies.  

During early-stage product development the labelling is likely to be in “draft” format and will undoubtably go through some improvements, reiterations, and changes prior to launch.

Prototyping and packaging

Prototyping is perhaps the activity that most scientists and technologist feel most comfortable with. However, it is important to be guided by the user needs and concept(s) that have been prioritized. The R&D team should be concurrently identifying what methodologies or test methods are going to be used to show conformity to the relevant General Safety and Performance Requirements (GSPRs) during the product evaluation and characterisation Stage (Stage 4).

Additional considerations at this stage include factors such as shelf life, sterilisation methods and storage conditions. This includes selecting appropriate packaging and it is often prudent to conduct preliminary (look and see stability and sterilization) tests with packaging as close to what is envisaged in the final product as possible to ensure that any issues are identified and mitigated as early as possible in the product development process.

Another consideration is the manufacturing strategy and whether the device will be manufactured internally or externally and importantly, whether manufacturing can be scaled up without compromising device performance or safety. Early engagement with suppliers and contract manufacturers combined with ensuring that medical grade materials are used, as far a possible,  can reduce the complexity, time and cost  associated with design transfer and composition of the Device Master Record (DMR).

Tailor your roadmap to your device – free consultation

The Innovation, Commercialisation and Regulatory Team are offering a new service in which we walk through the MediPath™ tool, starting from an introductory half-day session to more detailed evaluations and support depending on your needs. 

If you would like to discuss any of these stages or to understand how the roadmap can de-risk your innovation and accelerate the speed to market, we are offering a free 30-minute consultation. Contact us on [email protected]

Patrick Trotter PhD MBA (TechMgmt), Stefanie Lowry BSc, MSc