Oct 16, 2020

TestCard to launch home UTI test next month

Mobile Technology
healthcare app
home testing
Leila Hawkins
2 min
 TestCard to launch home UTI test next month
The mobile-enabled testing kit launches after startup secures investment to expand and grow product range...

A home testing kit that allows people to diagnose common conditions using the camera on their mobile phone has secured £4.5m in funding to expand internationally. 

Founded in the UK, TestCard aims to give people control over their health and take the strain off the National Health Service (NHS). Its UTI test kit consists of a set of testing strips and a smartphone app that turns the phone's camera into a clinical grade scanner, providing results instantly that can then be shared with a doctor or other healthcare professional. 

The investment, which has been secured via the venture capital firm West Hill, will be used for new product development, advancing regulatory applications, international expansion and further product launches. It will also help bridge the business through to its Series ‘A’ round, anticipated for the second quarter of 2021.

TestCard was founded by Dr Andrew Botham and Luke Heron, following a conversation about how bad people are at engaging with healthcare. They identified a potential for improvement by removing the delay in treatment - by facilitating an earlier diagnosis in people's own homes. 

Their aim is to make medical diagnostic testing more accessible to people at home through mobile technology, which can especially benefit people who find it difficult to access healthcare. 

TestCard launches in November, and there are plans to offer develop diabetic screening, pregnancy and ovulation tests, kidney function and a drugs misuse test in the future. 

The app has won several awards including 'Top Emerging Technology' at the Consumer Electronics Show (CES) in Las Vegas in 2019, an award that typically celebrates new product releases from established tech giants like Google and Apple.

Robert Caie, Managing Partner of West Hill Capital, commented on awarding the funding: “West Hill was most impressed with TestCard’s management team and technology and believed that the company would make a significant addition to our portfolio. TestCard is now perfectly positioned to benefit from a new world where home testing for a multitude of medical conditions or illnesses has become necessary in order to alleviate the strain on our healthcare services.”

Chris Craig-Wood, Chief Commercial Officer at TestCard, added: “We are delighted to secure this level of funding while still in our early stages as a business. It’s clear that diagnostic testing is an attractive opportunity in the current climate. This level of investor confidence speaks volumes about our ambitious growth plans in delivering disruptive, at-home healthcare solutions to the market across multiple territories.”

Share article

Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

Share article