Let us bring our twenty years’ experience in the application of LED devices for beauty and healthcare to support you in the development and commercialisation of your LED range. Our MDSAP accreditation for design, manufacture and distribution makes us your number one choice in phototherapy partners.
Our team
Sue is a Research Scientist with an MBA and a track record of continuous breakthroughs in LED therapies and the creation of regulatory approved devices.
Sue’s career has seen her hold significant roles in leading medical device businesses. Prior to forming iSmart, Sue was at Pacer Components, where amongst her pioneering work, she implemented a regulatory plan that delivered CE device approval for the treatment of Herpes simplex labialis, ultimately culminating in FDA clearance.
This product still remains the only LED device cleared for a shortened healing time indication in the USA.
As CEO of Phototherapeutics Ltd, Sue was responsible for multiple FDA clearances and 34 peer reviewed published papers. Amongst her many achievements, she pioneered the initial clinical research for anti-aging, acne and wound healing, now used as the gold standard protocols globally.
Sue D’Arcy
Laurence is a medical doctor with more than 16 years of clinical development experience in pharma, biotech and medical devices. He has served as Chief Medical Officer for a NASDAQ-listed US biotech company as well as Vice President and Chief Scientific Officer for a UK-based investment and clinical co-development company. Laurence has led multiple clinical development programs in partnership with big pharma partners such as Pfizer and AstraZeneca, and has a successful track record of gaining regulatory approvals for investigational products. Laurence also works in independent consultancy advising on life science investment opportunities for venture capital and private equity clients. He previously served as a development clinician at both Pfizer and Lundbeck, and co-authored a number of clinical papers in light therapy. He holds both a medical degree from the University of Liverpool, and a Masters Degree in Law.
Laurence Reilly M.D.
James joined the iSmart team with over 25 years’ experience in the Opto-Electronic Industry and a Degree in Physics from the University of Wales Aberystwyth.
In his previous role at Pacer Components, he focused on the customisation of products and the business value chain, managing the specialised design & build service division. Spanning the UK and Asia - and partnering with Chinese manufacturing - his team developed and delivered the Virulite Cold Sore Device for numerous Pharma companies across the world.
James was part of the MBO of Pacer in 2010, helping grow it until acquisition by Solid State plc in 2018, when he became Director of Operations.
James Woodhead
Andrew joined iSmart to oversee the operational aspects of sales, purchasing, logistics and finance.
His honours degree in Chemistry from the University of Birmingham has resulted in a number of breakthrough developments, from novel compounds for reducing blood pressure, to speciality adhesives for friction bonding. After experience managing clinical trials, Andrew then moved into operations and manufacturing roles, looking after key suppliers and distributors.
Andrew Bailey
David has over 40 years in the medical device industry, a degree in Biomedical Electronics and an MBA in Technology Management. He has held multiple roles in SMEs and multinationals, with significant experience and expertise in international medical device regulations and quality requirements.
David Didsbury
Charlotte has an extensive background in marketing events and client relationship management, with a degree in Business Studies. Having joined the iSmart team in 2018 Charlotte is responsible for marketing, managing efficacy claims, together with the ultimate success of customers’ projects.
Charlotte supports iSmart partners and customers with branding requirements and their regulatory compliance, ensuring clients are provided with all the necessary assets to succeed.
Charlotte Amos
Our credentials
Just a few of our milestones and achievements:
- Thousands of iSmart’s award-wining products have been sold globally, both under our own brand and as developed and manufactured on behalf of other’s brands
- Over 30 published, peer-reviewed clinical studies that validate our technology and support our clinical claims and safety information
- Validated by the Journals of Cosmetic and Laser Therapy, Photochemistry and Photobiology, American Society for Laser Medicine and Surgery, and many others.
- Global regulatory approvals include: USA, Europe, Australia, Canada and China. Japan and Brazil are pending.
- iSmart owns a broad patent portfolio.
Our
manufacturing
Our MDSAP ISO 13485, state of the art manufacturing facility covers design and manufacturing. The facilities substantial investment in advanced technologies and dedicated LED device production plant enables superb quality control and highly efficient manufacture. From prototype to mass production, iSmart controls the process on behalf of our partners at every stage, with no compromise on quality or safety.
In addition to MDSAP for design and manufacturing iSmart also owns an MDSAP Quality management system that covers distribution. iSmart can therefore cover all the legal requirements for distribution of medical devices for its customers.
“With a passion and focus on phototherapy innovation, development and regulatory services, iSmart are truly leaders in their field. Their nurturing approach to our partnership has been unique from day one, as has their commitment to our growth and success.”