Pragmatic product development for small organisations
SMEs with new technologies can understandably be drawn to high-level commercial milestones that are needed to secure important investments in the short term. With limited resource (in both people and finances), which is common in pre-investment stages, important steps that provide a firm foundation for future product realisation can be overlooked, or rushed, in the hope that they will be dealt with retrospectively.
For example, quality management and regulatory compliance are essential for some products and in certain sectors, but such matters can appear daunting, time-consuming, or simply not relevant given the competing priorities at play during those early days, especially when the cost may be a significant proportion of available funds within that business. Small in-house teams, where individuals often have many different roles, may also be less aware of industry methods or lack specific experience in applying them, so some aspects of product development can be neglected.
However, by applying a few basic principles, and with expert help in the right places, it is straightforward for small organisations to develop sufficiently robust management systems that will be compatible with future developments and help reduce wasted time and costly mistakes. Much of this comes down to planning, defining what you intend to build, and then proving that it works.
Define it
As a first step, identifying user requirements and what they mean in terms of the product design (so-called “design inputs”) are imperative for any product. These requirements are what your customer needs to do with a product (e.g. diagnose a disease), performance expectations (e.g. throughput, ‘accuracy’, etc), how it will be used (e.g. in a lab, point-of-care), or constraints (e.g. regulatory requirements, the market, costs/pricing, scale of manufacture, etc). This process could also identify a strong application that will embody your technology with a need that can be specifically tested during validation.
Within a team, it is important to recognise that the market may not have all the answers, especially for an innovative product. Some of the user-needs or design inputs may need to be creatively envisaged by the project team. It is also important to know when a product is “good enough” because progress can be hampered by the desire to chase incremental improvements with little impact on the end user’s experience. Requirements and design inputs should be specific and realistic but aim to make the product as good as it needs be – these are also likely to be used as a measure of company performance the next time an investment round comes around. Including a few “nice-to-haves”, or desirable requirements, in the design will allow step-changes in development when injections of funding become available through new investment or grant-funding or give the product an edge when it may be weak in other areas (automation, or portability of a manual lab-based test are examples of this in the field of diagnostics).
There can often be conflict between commercial and technical functions within a project team during these stages, but in practice, this is a creative collaboration between market and technical functions and will be a less successful project without cooperation.
Prove it
During technical development and optimisation, the user-requirements and design inputs for a product should always be kept in mind. Repeatedly checking that a product is performing adequately (or not) in these earlier design stages is vital. If it’s going to fail, it is best to find this out early so remedial action can be taken, or, indeed, a different direction! The aim in these phases is to increase the likelihood of success in the later phases of verification and validation (V&V), almost to the point that you know it will succeed before starting, or are happy to take the risk, so the targets should be kept in sight. It is also important to note that protypes don’t have to be the finished article, but they should be as close as possible.
V&V is usually time-consuming and costly, as well as being one of the most fraught phases of product development: so much has been invested in the product (effort and money) up to this point, and timely success is so often critical for the next phase of funding. If the product is a medical device or a diagnostic, this is where expert regulatory advice can be very beneficial, especially in the planning of performance evaluation and clinical studies. It’s never too early to start planning because it can take a long time to test a product under it’s intended use conditions or acquire enough samples or participants. Ethical approval may also be required, which can also take several months to set up.
Inherent safety
An important side note, particularly for regulated products, is to pay close attention to hazards and risk from an early stage because they are a critical part of management systems. Simple risk analyses are easy to start but can be very time-consuming and contrived if carried out retrospectively. Risk analyses that develop over time are also a great record demonstrating how a company has historically managed risk, with an aim to develop and manufacture an inherently safe product.
There are many approaches to risk management. Some hazards relate to the project (e.g. loss of key staff “x” leads to delay in “y”), whereas some are specifically for the product (e.g. the product cannot detect “a”, leading to “b”). Be clear about this difference in risk analyses and be clear about your definitions of the terms hazard, risk, severity, likelihood, etc, and how you use them.
Simplicity
In the early stages of a small organisation’s development, keep the product realisation approach as simple as possible. Set up a framework on which to build and apply some basic discipline; state what it is, what you want it to do, and then prove it. This is obviously a simplification intended for smaller projects, and each product is likely to contain many layers, but applying this kind of process-driven approach will assist in showing how product design is managed and will align with future management systems.
Awareness of significant barriers to product realisation is also key to avoiding long delays in the future, keep in mind potential approaches to manufacturing and regulatory compliance. Scarce financial resources should be applied to obtain the best value and to avoid needing to significantly back-track or repeat work. Success will be achieved with effective planning and applying resources in the right places.
• Apply some basic process and keep it simple.
• You don’t need to do everything; prioritise, and strategically select external expertise.
• Identify what is needed, rather than trying to push for perfection.
• Commercial and technical collaboration is vital.
Contact RLS today to find out more how we can support you! Our many services include mentoring, training and coaching.
Release Life Sciences (RLS) provide a whole range of personalised and diverse services designed to help life science and diagnostic companies of all sizes achieve their full potential.
Offering end-to-end solutions, ranging from R&D, commercial, marketing, scaleup and interim management solutions, to personalised mentoring, coaching and training services. In addition to the provision of interim resources, RLS can deliver bespoke support to you and your team.
Author: Matt Crow - RLS Associate and Director, UpStart Bio Ltd - Dec 2022
