Expertise

Merxin Ltd designs devices and turns them into commercial realities. We have designed generic devices to reproduce the performance and the idiosyncrasies of existing devices. We have designed new device platforms, and improved commercialised ones to enhance their performance and reduce their failure modes.

We offer a full design service: conceptualisation, prototyping, testing, all within our ISO 13485:2016 compliance so you can draft a medical device master file from our records.

The beating heart of Merxin Ltd is the high-quality device engineering that goes into our products. For our generic targets, this starts with a detailed analysis of the originator to understand the design, function and critical features. We then design our product to match the key performance factors, take advantage of improvement opportunities and ensure a device that is suitable for manufacture from the start.

Making a device targeted as a substitutable AB rated generic means matching the critical features that define the originator product. Ensuring the device looks similar is not enough: it must also be operable the same way, provide the same feedback to the patient during use and match delivery performance. We know how to build a generic device. This unparalleled expertise enable us to build robust originator devices.

Merxin Ltd employs a range of in-house and external prototype manufacturing capabilities to enable rapid assessment of concepts through to devices suitable for laboratory use in the final materials. By combining design capability with prototyping, iterations can be built, tested and evaluated quickly with immediate feedback to the design and development process.

Providing devices is what Merxin Ltd is all about. We establish supply chains to be able to manufacture batches of devices for clinical trial with capability of 100,000+. Products supplied are covered under our ISO 13485:2016 compliant QMS and appropriate manufacturing controls with validated equipment and batch documentation.

Our QMS enables the manufacturing to be captured in a way that the relevant documentation can be inserted in the application for clinical trials such as IMDP dossiers.

Our end game is the same as yours: commercial product sales. Building on the pilot-scale clinical production, Merxin Ltd leads and manages industrialisation of the devices, working closely with manufacturing partners to create capability to support long-term high-volume supply of product to the market. We are flexible about manufacturing location and control. Manufacturing options range from Merxin Ltd controlled manufacturing plants to clients’ own facilities to comply with local importation regulations. The final arrangements depend on the clients’ expertise and objectives.

Working in the medical industry means complying with the requirements laid out by regulatory agencies. Merxin Ltd are ISO 13485:2016 compliant and structure programmes to comply with expectations of key EU as US markets. This includes structuring the development process and accompanying documentation to meet Designs Controls under the Medical Device Regulations in Europe and 21 CFR Part 820 in the US.

As an essential part of both engineering and regulatory activities, Merxin Ltd performs extensive testing of devices. Engineering evaluation of designs and devices from concept through to commercial market form is critical to ensure product meets the design intent and performance requirements. Assessing this formally under Design Controls provides the evidence for regulators that a design is fit for purpose. Merxin Ltd carries out these tests on your behalf.

Inhaler devices must fulfil a number of stringent safety tests before release. Leachables and extractables studies are necessary to demonstrate that the construction materials of the device are safe. In practice, this means that the device, in particular, the primary packaging containing the API formulation, will not contaminate the formulation nor induce a degradation and that the device is safe for handling by human beings. Tests must be conducted to ensure no materials from the device are shed during use or storage nor leached into the formulation. The construction materials must also not contaminate the patient. In the case of inhalers, this means ensuring the device can be touched by the patient’s fingers and placed in the patient’s mouth with no danger. New regulations are being discussed to ensure that devices do not let organic volatile compounds enter the airways. Merxin Ltd will guide you to understand these requirements and conduct appropriate studies to document these safety assessments.

Merxin Ltd provide support for compilation of the Technical File for registering devices under CE marking where they are supplied as a separate component of the Drug Product. Inhalers now fall under the Class II b classification and require some element of clinical testing we will be happy to assist you with. Our QMS ensures that the documentation required for CE marking devices is readily available.

Establishing the performance of devices is required in both in vitro and in vivo. For generic products, the device resistance can be measured in the laboratory and compared to the originator. However, lab testing is not enough on its own and the performance of the device must be demonstrated in a clinical environment with a “Peak Inspiratory Flow” study. Merxin Ltd supplies the technology and expertise to support these studies.

Of much increased focus in the last 20 years is how devices are used in real life. What may seem obvious to a designer does not always translate to use by patients, creating opportunity for use errors that may impact device and dose delivery function. Getting the design right to reduce use errors is key to a good design. For substitutable generics there is an extra level required to evaluate the patient interface with the device and demonstrate that they are similar. Specialist Human Factors studies are required to evaluate designs, providing insight for designers and evidence for regulators. These studies are now an imperative for filing inhaled products in the USA. Merxin Ltd will provide you with the relevant support to conduct these studies.

State of the art equipment allows us to support device performance characterisation. We are able to measure aerosol droplet size distribution with a fully set-up Malvern Spraytec with an inhalation cell. We perform device resistance tests routinely during development but also during specification testing for product release. We are equipped to measure peak inspiratory flow rates with the Merxin Ltd designed PIF-meter; PIF data is necessary to justify flow rates in performance testing of inhalers in support of clinical studies. We support plume velocity and geometry testing for MRX004 soft mist inhaler with a view to product filing.

We do not merely design devices: we make sure you have the data to file your finished dosage form dossier.