The concept of modularity has variously been applied to myriad fields including evolutionary biology, psychology, industrial design and architecture, manufacturing, engineering, computer science, and far more besides. Clarifying what it means is therefore not straightforward due to the broad, abstract nature by which modularity can be perceived through distinct disciplinary lenses.
The biopharma industry has begun to apply a modular methodology to design certain medical devices, such as autoinjector products. Aligning with a broad general definition of modularity from the engineering realm, this involves a “systematic process”, wherein a “product or system […] composed of various modules […] can be combined in different ways” to create “different products”.
Autoinjectors also defy overly simple categorisation. Yet as a loosely defined group of medical devices, they represent an integral part of the solution to an increasing need for self-administered parenteral medication. Some distinguishing features of autoinjectors are that they are self-contained injection devices with the needle pre-attached and hold a pre-set dose of a drug. They function using a calibrated spring or a similar power source to push the medication from the device through the needle and into the target tissue.
Driven by a dual-desire to support patient convenience and respond to the growth of chronic diseases, new autoinjector technologies which can be rapidly deployed at scale are necessary as the biopharma industry pivots to meet demand.
To satisfy the challenge of aligning pharmaceutical manufacturing optimisation with complex medical needs, especially the frequent need for polypharmacy to manage and treat patient multimorbidity, autoinjectors must become as customisable as possible. From design to production, modularity is thought to be one of the most effective ways for the injectable medicines market to achieve the goal of maximum flexibility, scalability, and timeliness.
A glimpse of the injectable landscape
According to SHL Medical’s analysis, combination products currently available in autoinjector formats have been submitted for regulatory approval in a range of territories by a relatively small number of companies.
The wider drug delivery market has historically shown consistent, healthy growth, despite the grim realities of the pandemic. As the world begins to recover from the long-lasting effects of COVID-19 and approaches a period of greater stability and normality, drug deliverables are expected to flourish according to GlobalData’s latest fiscal forecast.
Autoinjector devices are already widely used to provide medication and treatment for a broad variety of chronic diseases, and life-threatening events like anaphylactic shock, heart attack, and stroke, to name but a few.
Rheumatoid arthritis is the chronic disease currently being treated with the greatest variety of autoinjector products. According to the WHO, there are approximately 14 million people suffering with this disease worldwide. Alongside pain, reduced mobility, and other symptoms, Musculo-skeletal conditions in general are “associated with significant mental health decline and deteriorated functioning”, highlighting the urgent need for the widest possible range of robust treatment options. Autoinjector technologies can play a pivotal role in facilitating this.
Analysis by GlobalData suggests that chronic diseases such as rheumatoid arthritis and multiple sclerosis are expected to increase in various major pharmaceutical markets between now and 2025, further highlighting the growing need for effective home-based treatment options.
Many of these debilitating conditions can be potentially fatal, making the need for fast and reliable treatment options delivered in the comfort of a user’s home a crucial factor in improving patient outcomes. At a global level, heart disease and strokes were the leading causes of death from non-communicable diseases in 2019.
Clinical trials data gives a further indication of how research into novel drugs and medicaments for many different categories of disease, which are treated in a parenteral fashion, may lead to increased demand for autoinjector products catered to the unique requirements of each treatment plan.
Embracing modularity across product lifecycles
SHL Medical is one of the companies seeking to demonstrate how the MedTech and biopharma industries can profitably move from the relative insularity of platform-based combination products, to more flexible platform technologies. The Molly® family of customisable autoinjectors is indicative of how modularity built upon an established platform can enable efficient, scalable production methods geared towards the end goal of patient-centric healthcare.
Harmonising all aspects of product design, manufacturing, and testing within a highly flexible system that has modularity and vertical integration at its core is already proving to be a winning formula for some companies. For example, SHL have shown what can be achieved in the customisable autoinjector sphere by using a modular ethos with respect to both product design and manufacturing.
This dynamic synergy can prove to be highly effective when it comes to minimising communication problems, process errors, and idle time with respect to logistics. An agile parallel development and production method is likely to pay dividends to those willing to invest in integrating all aspects of the product lifecycle process.
Companies wishing to leverage the benefits of modular platform technologies whilst satisfying stringent regulatory requirements, such as the US FDA CFR 820.30, and the harmonised Quality Management Systems (QMS) standard ISO 13485, will need to adopt a similarly rigorous design and production methodology if they want to innovate and compete in this space.
Modularity aids simplicity and customisation
Customisation options are inherent to a design strategy shaped by modularity, meaning that various product features, particularly visual aids to help end users distinguish between medicines, can be changed to suit diverse specifications. Modular platform technologies can also be designed with simple aesthetic customisations, such as unique colour schemes, to aid brand and medicine differentiation.
Molly® products are good examples of how modularity and simplicity can facilitate usability. Currently available in 1.0 mL and 2.25 mL dosing variations, these autoinjectors are engineered to provide a user-friendly “uncap and inject” approach which emits two audible clicks to signal the start and near the finish of the injection process. Subcutaneous medicaments are administered with a simple “push-on-skin” approach, followed by an automatic needle cover lockout to ensure patient safety.
Empowering people who are suffering from debilitating conditions and adverse situations to be able to safely administer their own medicines at homes is central to any biopharma company wishing to adhere to a patient-centric ethos. Molly® products provide a helpful example of how this can be done at scale. SHL’s Molly® family of autoinjector devices are already being successfully deployed to help patients with myriad illnesses currently requiring parenteral treatment, covering 85% of the most common afflictions requiring injected medicines.
Towards an interconnected and sustainable future shaped by modularity
As connected therapeutics become increasingly commonplace, biopharma companies investing in new digital strategies to ensure they are well placed to adapt to disruptive technologies are likely to steal a march on their peers. According to research by SHL, connected autoinjector devices represent one facet of the prized jewel enabling “decentralised precision care” to flourish in the digitally enhanced ecosystem of Healthcare 4.0. Yet pharmaceutical companies will need to adopt fresh mindsets shaped by a culture of innovation, “digital health workforce diversity”, and external partnerships if they wish to achieve this.
The biopharma and MedTech industry are facing a much bigger challenge than the need to adapt to shifting market forces and advanced technologies. As humanity grapples with the sobering realities of the climate crisis, and the world looks to COP26 for major action on addressing the need to radically decarbonise the global economy, bold steps must be taken to achieve net zero and the broader goal of a truly sustainable future. SHL is one of the companies already trying to address this through their ESG strategy, which features a range of measures incorporating sustainability at the very heart of their product design, development, production, and deployment procedures.
Modularity in product design and manufacturing is the key to unlocking the customisable autoinjector market, yet the rising tide of enhanced interconnectedness populated with myriad smart technologies is clearly much bigger than a single category of products. The landscape is also becoming more nuanced and coloured by an increasingly urgent need to have sustainability as a non-negotiable part of picture.
Savvy players in the biopharma industry can seize the opportunity of embracing modularity, sustainability, and digital proficiency across the board to ensure their portfolios are fit to survive the transition to Healthcare 4.0.