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Our team has a deep knowledge of a variety device types and how to effectively deliver sensitive biologics, and small molecules. We have specific expertise in ophthalmic drug delivery, soft mist inhalers (having worked for Boehringer Ingelheim on the Respimat) and on generic competitors, and delivering cell and gene therapies.
We deliver all of the device development phases or can work on specific phases individually as required. We can also provide technology scouting, root cause analysis, problem solving, due diligence, expert review, and device portfolio strategy management.
Many of our clients are multinational pharmaceutical companies or major medical device manufacturers. They often think of us as their device development group, and we build strong strategic relationships across multiple devices and platforms.
Injectors
Sanner has many years of experience designing and developing autoinjectors, pen injectors, on-body delivery systems, and needlestick safety systems for our clients. We also perform design, development, and characterisation of primary packaging components and systems such as syringes, cartridges, vials, septums, plungers and stoppers. We work on full device development projects, as well as problem solving and risk analysis of devices already in development or on the market to reduce time to market, reduce risk, and minimise cost.
Our team of experienced experts span the disciplines of human factors, concept generation, detailed engineering design, engineering science, design for manufacture-and-assembly, materials science, drug-device interactions, electronics, software, and regulatory support.
In addition, we have specialist experience in developing and proving devices for emergency therapies which require extremely high reliability, and demanding applications such as ophthalmic and catheter-delivered therapies. We strive for user preference even for the most complex indications and difficult-to-deliver therapies such as viscous biologics and cell-and-gene therapies.
Inhalation
Sanner has a breadth of experience in the design and development of devices across the inhalation field including:
· Dry powder inhalers (DPIs)
· Soft mist inhalers (SMIs)
· Pressurised metered dose inhalers (pMDIs)
· Nebulisers
· Nasal inhalers
Combining solid understanding and experience of the inhalation field with strong engineering and scientific skills, we have the expertise required to tackle your development challenges. With experts in fluid mechanics, materials science, engineering design, and other scientific disciplines, the team has knowledge required to fully understand the mechanisms of your device, from scientific principles, such as aerosol performance. We understand the importance of human-centred design from the start of development and have experience designing and conducting usability trails for inhalation devices.
Transdermal
Our end-to-end experience in developing transdermal drug delivery devices helps clients to get their device to market. The complexity in dosage variability alone means that our deep knowledge and experience enables us to design and develop a successful device for our clients. But we don’t just stop there. We understand that in order for a design to have an impact, it needs to deliver at every stage of the development process from sourcing materials, having a sustainable supply chain and manufacturability.
Optimal manufacturing processes are a key component to market success, and we are rigorous in our quality management processes and adhere to ISO 13485 regulatory controls at each step of the project. We can help source the best materials and delivery method to suit the viscosity of the drug itself, whether that is via microneedles, solid microneedles or coated microneedles. A key part of the projects we deliver for our clients focuses on scalability and sustainability of the device life cycle that offers a competitive edge with rapid routes to market.
Infusion Pumps
One of Sanner’s longest-running device development projects involves the construction of a novel infusion pump technology from the ground up. As a result, we are in a unique position to offer significant expertise of the industry landscape of stationary and ambulatory infusion pumps including any new technologies in the pipeline. We can assess whether your new or upgraded technology can disrupt what is generally regarded as an established sector with a few key players.
Sanner has carried out multiple Human Factors studies regarding the usage of infusion pumps. We can design the right study for your product while keeping any findings confidential.
As a medical device, infusion pumps must navigate regulatory frameworks such as the EU MDR & US FDA Title 21 CFR. We deliver all projects within our ISO 13485-accredited Quality Management System and can ensure that regulatory compliance is observed from the beginning of development, avoiding the need for any problematic ‘catch-up’ later. We have experience applying risk analysis techniques such as Failure Modes and Effects Analysis (FMEA) at an early stage and evolving it alongside a product design.