The Medtechtomarket team has worked successfully to provide solutions and support at varying stages of the product lifecycle, for a range of novel devices. Below are a few examples of past successes.
Refining and improving performance to re-launch
We were approached by a team that was struggling to demonstrate proof of principle and concept verification on a new point-of-care diagnostic system project, co-funded by the Department of Defence in the USA.
Medtechtomarket first led a Due Diligence process, providing a detailed critique of the product design, underlying technology, design for manufacture, and a gap analysis for FDA 510(K) submission. We were then called upon to deliver the full project by enhancing performance of the system (comprising a portable analyser and disposable test cartridges), and taking the product through to manufacturing and full market launch.
The Medtechtomarket technical development team fully redesigned the test cartridge within six months, with three additional patent applications filed and assigned to the sponsor. A clinical trial process was also initiated, with several hospitals enrolled. A new instrument mechanism was designed, and full development was fast tracked in order to deliver the whole project in under 18 months. The newly designed product significantly outperformed the laboratory reference method in terms of precision, accuracy, and assay time, and was more than 90% less expensive to manufacture than the original product
The verification and validation plans were submitted to the FDA as a pre-submission, and the company also introduced a system check cartridge and blood plasma liquid controls. The project was completed and closed by the Department of Defence. Medtechtomarket guided the system through to the manufacturing stage, with submissions expected towards the end of 2015, and we are now actively involved in the long term strategic planning for the business.
Delivery of market-ready product from initial bright idea
Medtechtomarket was brought in by the company founder and investors to complete development and commercialisation of an innovative addition to an
For this project we first conducted a full financial and market review, to understand the best way to enter the market and maximise the business potential. From this we developed a revised strategy and wrote a new business plan. Nearly £2m funding was raised through VCs, angel investor networks, angel co-funding and private investors, resulting in Medtechtomarket being shortlisted for ‘Investment Deal of the Year’ by the UK Business Angels Association.
The breadth of experience and technical skill within the Medtechtomarket team enabled rapid product development, producing an effective design and successfully navigating clinical evaluation, validation and regulatory approval. The team was then able to drive a timely early manufacture process with one of our FDA Accredited manufacturing partners in China, and guide CE marking and FDA approval, to ensure the product was ready for US launch.
Early sales figures and feedback have been very encouraging, the business is currently working with distribution partners and we are excited to manage the continued progress of this product in the market.
Re-assessing the market need to take a product to market-ready status
When approached by an NHS Trust and VC investors to start the development of a novel cardiac diagnostic assessment system, the experience of the Medtechtomarket team led us to take a step back and recommend a critical market examination and review before moving forward, as we felt the positioning within the market may need adjusting for maximum impact.
The evidence generated through the critical review supported Medtehtomarket’s initial view, and the device was therefore repositioned as a first line diagnostic rather than a niche assessment tool. This decision at a critical stage in the product lifecycle has been a significant factor in its success.
Following on from the initial assessment, Medtechtomarket’s team then supported the hardware, software and mechanical design, including creation and validation of complex programming algorithms, and providing quality management support. At a later stage, the expertise of the product development scientists and manufacturing specialists was again called upon to guide the product through Good Laboratory Procedure (GLP) verification and validation, and manufacturing planning and execution.
Calling upon experience and contacts within the financial sector, we have conducted successful fundraising rounds as well as winning more than £1m in grant awards. The funding has in turn enabled the company to conduct health economic surveys that have shown the UK’s NHS would achieve cost savings in the first year, if the system was widely adopted. The surveys were also able to show that the features of the system fully met the needs of prospective users.
We have also begun preparation for clinical assessments and supporting work to allow USA product launch, with clinical evaluation carried out at world-renowned medical sites providing a strong data set. The device is now being taken through to market-ready status, including generation of packaging, labelling, user manuals, and branding.