University College Dublin

Jabil experts offer design for sustainability advice to reduce the environmental footprint of drug delivery devices and other high-volume medtech products. By Conor Mulcahy and Oliver Eden, Jabil Sustainability plays a critical role during the early design phase of a medical device. About 80% of a product’s environmental impact is determined in its design phase. If sustainability is a key requirement for the product, designers should leverage design for sustainability (DFS) principles to deliver a solution that will account for the reduction of resources used and maximize conservation across the manufacturing value chain while also lowering the total cost of goods over the lifecycle of the product. This experience was leveraged to maximize the sustainability of the Qfinity autoinjector, giving it an 80% lower carbon footprint than market leading mechanical disposable auto-injectors. Here are six lessons from the Qfinity autoinjector’s design and development that medtech engineers can use to develop more sustainable devices. 1. Clearly understand the device’s intended use, function and lifecycle. The type of device you are building will impact all of the sustainability considerations we’ll discuss below. Engagement with patients and healthcare professionals during the design process is very important. Understanding their needs and behaviors helped guide the Qfinity autoinjector’s design to deliver medication as simply as possible, improving patient adherence and compliance while reducing the risk of errors and misuse scenarios, which maximizes the device’s sustainability. Devices also need to be appropriately designed to be robust and reliable for their expected lifecycle. Engineering safety factors need to be sufficiently robust to meet the requirements but not over-engineered, which can add cost and complexity when not needed. For the Qfinity reusable autoinjector, we leveraged cross-industry experience designing products for sustainability and focused on getting the product requirements document (PRD) correctly defined. As a device moves through the design process, these disciplines must be maintained or you run the risk of reducing the product’s overall sustainability performance. 2. Optimize your material selection. Optimized material selection is one of the most crucial elements of sustainable design. At Jabil, we’ve developed a database to compare various materials for medical devices on a range of criteria for sustainability, including: recycling method, environmental impact of the material’s production, carbon footprint of the material’s supply chain, the supplier’s sustainability credentials, and the material’s expected outcome post-use. It’s important to consider the environmental impact of the materials used, especially plastic resins and other common medtech materials. The use of recycled plastics is a potential frontier, but there are challenges due to scale (with reliable sources of recycled materials lacking) and the risks of contamination and material traceability. However, another option is a bio-based resin that is not sourced from fossil fuels. For example, Celanese has developed Hostaform MT POM ECO-B, a sustainable medical grade material which is almost identical to their existing POM product, but is made up of around 97% bio-content. This biogas-derived material has less than 50% of the carbon footprint of the original material produced from fossil fuels but meets the same performance criteria. 3. Modularity matters. When possible, device design should leverage interchangeable parts and allow for easy repair or replacement without discarding the device. The Qfinity autoinjector’s platform design covers both 1 mL and 2.25 mL, connected and mechanical, with mechanisms that have 80% common parts, assemblies, and manufacturing processes. This modular platform approach allows the manufacturer to industrialize a single manufacturing cell to serve all variants, reducing the manufacturing footprint and energy consumption. 4. Get circular. Reusability was a critical area of focus for our Qfinity autoinjector design team. The European Federation of Pharmaceutical Industries and Associations (EFPIA) released a whitepaper calling on the pharma industry to increase adoption of circular economy principles to better preserve resources and maximize product lifecycles. A reusable autoinjector is a compelling solution for the opportunities described within EFPIA’s analysis and bears out advantages that single-use injector products just cannot match. 5. Consider sustainable manufacturing methods during design. Energy use during production adds up for high-volume devices like autoinjectors. Injection molding is highly energy efficient when producing large quantities of identical parts. Meanwhile, engineered thermoplastics ensure durability and compatibility with medical standards but also support recycling potential, further enhancing sustainability. 6. Stay sharp on industry regulations. Designers need to ensure sustainability initiatives align with regulations and standards such as the Waste Electrical and Electronic Equipment (WEEE), Restriction on Hazardous Substances (RoHS), Registration, Evaluation, and Authorization of Chemicals (REACH), and the Energy Using Products (EuP), all of which have already positively impacted the sustainability of medical devices containing electronics. Designers must also stay aware of national and international laws — like the European Union’s Corporate Sustainability Reporting Directive (CSRD) — that may have a trickle-down effect on their design choices. There are now programs to reduce medical device waste by returning used devices for recycling, repurposing, refurbishing and reuse. Jabil operates three medical device reprocessing plants in Maple Grove, Minnesota, that process and repackages thousands of medical devices every year. But these programs present additional regulatory hurdles, such as establishing a safe means of returning the devices with a low burden on the user and developing infrastructure to introduce the returned devices safely and efficiently into the circular economy. Designers should consider how or if medical reprocessing will play a role in their design for sustainability and understand the associated regulatory challenges. Conor Mulcahy is the senior director of research and development in Jabil‘s healthcare division, responsible for the development of strategic capabilities to support pharmaceutical solutions, and was the Qfinity autoinjector development engineer responsible for the technical development of the solution to meet the product requirements. Mulcahy holds a master’s degree in engineering design from University College Dublin and a bachelor’s degree in mechanical engineering from Ulster University. Oliver Eden is a senior business unit director for Jabil‘s healthcare division, focused on pharmaceutical solutions, and was the product manager responsible for strategy to deliver the Qfinity autoinjector and meet customer and market requirements. Eden holds a Ph.D. in biomaterials engineering and master’s degree in mechanical engineering, both from the University of Exeter. How to submit a contribution to MDO The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) Medical Device Regulation (MDR) Class IIa certification. The certification means the cognitive impairment screening tool is safe, effective and compliant with the governing laws. CCE aims to give primary care, specialists and researchers an accurate digital cognitive assessment tool that is brief and easy to dispense and brings clarity to early cognitive impairment. It also combines objective analysis of cognitive performance with qualitative metrics designed to deliver brain health insights and a customized action plan to treat the disease. "The growth of dementia is a significant public health problem across the world," Dr. Alvaro Pascual-Leone, Linus Health chief medical officer, said in a statement. "Earning EU class IIa MDR certification allows us to expand our offering in the EU beyond assessment to include clinical decision support, which is critical in supporting clinicians to navigate next steps, consider concrete, actionable recommendations, and connect patients with the right care and clinical interventions that have been shown to delay or even prevent the onset of dementia due to Alzheimer's disease or other causes." THE LARGER TREND In October, Brook Health collaborated with Linus Health to allow patients to be screened, assessed and sent home with a treatment strategy for cognitive issues on the same day. The marriage of Linus Health's advanced digital cognitive assessment tools with Brook Health's remote care platform aims to empower primary care physicians, making early detection of mild cognitive impairment, a forerunner of dementia, as standard as other preventive screening methods. The company made two acquisitions this year. In July, it acquired Together Senior Health, a brain health company for individuals suffering from cognitive decline, and in March, it purchased Aural Analytics, which provides clinical-grade speech analysis. In 2022, Linus Health acquired Kinesis Health Technologies, an Irish startup focused on physical-function assessment. A University College Dublin spin-out, Kinesis focuses on digitally assessing gait, balance, mobility, fall risk and frailty. Linus Health said the acquisition will help it expand its scope of services to include both physical and cognitive assessments.

CAMBRIDGE, England & BOSTON--( BUSINESS WIRE )--Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk patients through the power of dynamic biopsy technology, announced it has been invited to join EVEREST, a leading European consortium. The consortium’s objective is to advance EV research, innovation and clinical translation for the benefit of patients. Mursla Bio’s selection demonstrates the Company’s leadership in the field, particularly in developing EV-based disease surveillance and diagnostic tests. This consortium comprises 22 institutions, academic and non-academic and over 80 Marie Curie Scientific fellows across 11 European countries and will promote the exchange of expertise to advance EV science and its clinical applications in disease management. Mursla Bio will provide oversight on the work package ‘ scaling and commercialization’ of EV products, especially for clinical diagnostics. Additionally, Mursla Bio will host researchers from institutions across Europe and send staff members on secondments to other partners. Mursla Bio’s dynamic biopsy technology combines the accuracy and disease sub-typing capabilities of tissue biopsies with the ease of liquid biopsy sample collection, providing a non-invasive intervention with comprehensive biological insights. This is made possible by advanced EV science and an innovative extracellular omics approach, supported by Mursla Bio’s technologies. These technologies include organ-specific EV isolation from biofluids for precise targeting, an AI-enabled multi-omics workflow for disease biomarker identification, and a scalable assay platform using optimal biomarkers for clinical use. Pierre Arsѐne, Founder and CEO of Mursla Bio said: “As a leader in EV science and its clinical applications, we are pleased to have been selected to join the EVEREST consortium as an industry partner. Our cross-Atlantic expertise will guide the consortium in scaling up and commercializing clinically relevant products. Together we aim to shape the best of EV research into highly innovative clinical tests that will benefit millions of patients over the next decade.” Dr Tom á s Dias, CSO of Mursla Bio added : “As the field of EVs is progressing rapidly, initiatives like EVEREST—which bring together academic and industry partners—are essential to facilitate the translation of scientific discoveries into clinical insights. The scientific exchange within the program will greatly benefit the field, with Mursla Bio contributing its expertise to channel the best of EV scientific innovations into clinical products.” The EVEREST project, beginning January 2025, is co-ordinated by the University College Dublin and will receive funding from the European Union’s Horizon Europe research and innovation program under grant agreement No 101183034. For further information on Mursla Bio, please visit https://mursla.com/ .