Biocompatility testing

Biocompatility testing

Family fortunes – meet Morgan IAT, the medical device manufacturer helping innovators get to market


Getting even the most innovative medtech concept onto the global market is a veritable minefield. Many promising technologies never make it into formal development, let alone negotiate the major R&D, clinical and regulatory hurdles. But there are exceptions to the rule. Sophia Ktori discovers how one medical device manufacturer, Morgan IAT, is helping startups through development

medical device manufacturer

Haptics Prototype device

It’s not necessarily design, efficacy or even market viability issues that cause products to falter, suggests Sue Clarke, Managing Director of Hampshire-based Morgan Innovation and Technology (Morgan IAT). Rather, she suggests, the primary challenge is, as ever, money. ‘Particularly for individual inventors, university and other academic groups or startups, funding represents one of the single most important stumbling blocks. People are having to be a lot more creative about how they raise their capital, using approaches such as crowdfunding as an alternative to traditional bank loans and overdrafts.’

Investing in innovation

Established in 1987 by Sue and her engineer husband Howard, Morgan IAT develops and manufactures innovative products, primarily in the medtech sector, but also in other industries. The firm exports 90 per cent of its products, and in 2016 – for the second time in five years – won the international trade category of the Queen’s Award for Enterprise. Unusually, Morgan IAT also ploughs 20 per cent of its turnover back into speculative R&D.

medical device manufacturer

Morgan IAT product design meeting

‘Our aim is to support innovators who are struggling to get funding for promising early stage projects,’ explains the Clarkes’ second son, Nigel, who has been Morgan IAT’s CEO since 2015. ‘Of course, part of our own business strategy is to expand and diversify, but primarily we want to help innovators who can’t otherwise get their products into or through development. As a small company, we are completely flexible about how we structure our agreements and partnerships, and this means that we can almost always find the best solution for each product that we take on.’

Morgan IAT offers complete design, R&D, clinical trials and regulatory expertise for the European Union, US and other international markets, together with commercial manufacturing capabilities, all at its Petersfield site. ‘We are an FDA-approved registered manufacturer, so we can export to North America, as well as Europe and further afield,’ Nigel adds. ‘This gives us a major advantage when it comes to securing manufacturing deals with some of our partners.’

Transatlantic relations

medical device manufacturer

Test Engineer testing a Neurotherm 2000 iX

It was the company’s experience in developing and commercialising Howard Clarke’s flagship invention, a minimally invasive pain relief device called Neurotherm, which prompted the decision five years ago to support other inventors. Neurotherm is a radiofrequency lesion generator that targets and destroys the sensory nerve endings that send pain signals from the spine to the brain. St Jude Medical owns the commercialisation rights to the family of devices, and Morgan IAT has a rolling manufacturing contract, and continues to develop and improve the Neurotherm devices. It exports up to 120 units every month to St Jude Medical, which distributes them worldwide. ‘Unusually for a US company, St Jude Medical is happy for us to continue to manufacture in the UK, and it is this relationship that has been key to us winning the Queen’s Award for a second time.’

Striking the right deal

Morgan IAT manufactures a second product, the PulseFlow boot, for patients with diabetic foot ulcers. The device is the brainchild of venture-capital-funded startup, PulseFlow Technologies. ‘The PulseFlowDF boot is designed to help foot ulcers heal by mechanically stimulating blood flow,’ Clarke explains. ‘We structured a deal with the originators, under which we have carried out development at essentially cost price, in return for the manufacturing rights. We took the risk that the product would work and sell, and have successfully progressed it through CE marking and FDA 510(k) approval. Since the start of 2016, the PlusFlow diabetic foot-ulcer boot has been in full commercial manufacture.’

Making a difference, not just a profit

The medical device manufacturer is also taking another 10 projects, mainly in the medtech sector, through development. The projects are at varying stages, with some nearly complete and others just starting, Sue points out. ‘We are looking for projects that will really have an impact and not just make a profit. One of the most advanced is a home test that pregnant women can do once a week to monitor changing levels of salivary uric acid as an early predictor of pre-eclampsia or foetal distress.’

Telehealth home test

medical device manufacturer

Salurate early product design

The original concept for this Salurate Test was developed by the late Dr Brian Owen-Smith, who carried out a small-scale trial to test the correlation between changing salivary uric acid levels and pre-eclampsia. ‘We set up a joint venture and carried out a much larger trial at five NHS trusts,’ Sue explains. ‘The aim now is to complete the development of an inexpensive home test using telehealth to transmit the results via smartphone to a Cloud-based data system. If a woman’s uric acid levels are rising week on week, the automated system will alert the clinician.’ Morgan IAT and its joint venture partners have yet to decide how they will commercialise the test, she points out. ‘We are principally a research, development and manufacturing company, so in this case we may sell off the product to a more experienced commercialisation partner who will be able to increase its global reach.’

Nurturing young inventors

As well as joint venture and manufacturing deals, Morgan IAT has secured a number of royalty based licensing agreements with universities. One such agreement, with King’s Health Partners, is for a small, inexpensive anti-snoring device that is attached to the jaw by sticky pads before sleep, and which emits a mild electrical stimulus to contract those throat muscles that help to keep the airways open. A separate collaboration between Morgan IAT and the University of Southampton is developing a haptic device for the hand, which could help patients recovering from stroke or brain trauma, but which the partners also aim to develop for the gaming and virtual-reality gaming sectors.

Morgan IAT is also separately working with a young inventor who has developed a portable premature baby incubator that could save lives in remote settings such as disaster zones and refugee camps. ‘In this case, the inventor wants to keep hold of his product rights, so we are offering to do the development at cost price in exchange for early manufacturing rights,’ Nigel explains. ‘We are also providing him with space in our offices, so in a sense we are acting as a small-scale incubator.’

Morgan IAT aims to manufacture an additional two to four products within the next few years and will continue to reinvest 20 per cent of all turnover in new R&D projects. ‘The greater our turnover, the more we invest,’ Nigel explains. ‘The team carries out rigorous market research on potential projects before any talk of deals, but we also have to get on with our partners,’ Sue stresses. ‘Last year, we were shortlisted for a Daily Telegraph small business award, and that publicity led to a number of enquiries. Unfortunately, we can’t help everybody, but even for those projects we don’t take on, if we can provide advice, then we will.’

Keeping it in the family

Morgan IAT is a family-run company and another five families – either husband and wife, or parent and child – are also involved in the business. ‘We have a strong staff-oriented ethos,’ Sue stresses. ‘We introduced flexitime back in the 1990s and, since 2010, our staff have had the option of a four-day working week (working their full hours in four days and then having a three- day weekend). Ten per cent of profits are shared out among our employees every year. In addition, we operate a graduate scheme, hold regular careers evenings and take on work-experience students from local schools and interns from universities. Our graduate entrants are introduced to different departments over a period of months to find out where their strengths lie, and eight of 11 graduates that have worked at Morgan IAT over the last three years are still with us now.’

The medical device manufacturer’s successful business model means that it is also outgrowing its Petersfield site, and it is looking to relocate locally. ‘We are a close working group of 39 people, but as we take on more projects we need to expand our R&D and other departments, and we are now bursting at the seams,’ Nigel says. ‘Our expansion confirms the success of what we believe is a unique approach to developing promising new technologies, primarily in the medtech sector where we have most experience, but also in other areas of industry.’

About the author

Sophia Ktori writes about pharmaceutical, biotechnology, life sciences, healthcare and medtech for academic and scientific publications.

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