welcome

INDX is an EU funded Horizon 2020 project that seeks to develop an innovative implant that restores natural motion to patients with thumb base joint arthritis.

1 in 10 people have some degree of thumb base arthritis with many choosing to put up with the discomfort because of limited treatment options.

5% of the world’s population have severe symptoms. This increases to over 30% for women over the age of 55.

There is in excess of 200,000 surgical procedures carried out each year in the EU and US combined for severe thumb base arthritis.

TEAM

The InDx consortium is a group of innovative, world-leading, and complementary companies, who can significantly accelerate the InDx implant to market to meet a huge unmet clinical need. Loci Orthopaedics, EndoLab, and NAMSA have already started work on the performance testing and clinical trial plan required for the EU regulatory approval. Medvie has a strong expertise in medical device design, project management, and global commercialisation and have initiated a commercialisation plan for the InDx implant.

Loci Orthopaedics is an innovative orthopaedic solutions company.

Loci Orthopaedics is a multi-award winning medical device start-up company based in Galway, Ireland. The company is focused on the development of novel technologies to meet unmet clinical needs in orthopaedic medicine, specifically, the rapidly growing market of upper limb surgeries.
This year, the company has had a US patent granted for the core technology on which its InDx Implant System is based. The InDx Implant is the first evidence-based implant for the treatment of thumb base joint arthritis, a common but crippling condition affecting over 100 million people worldwide.
Loci Orthopaedics raised over €6M to accelerate this product to commercialisation, reflecting both the extent of the unmet clinical need as well as the company’s novel solution to this need.
Another extension of the company’s product development portfolio has been the addition of the OsteoAnchor
technology after a licencing deal with NUI Galway. This technology is a 3D printed surface finish that enables implants to embed into poor quality bones. The company plans to use this technology to increase the number of patients who can receive potentially life-altering surgeries across a spectrum of orthopaedic conditions

DR BRENDAN BOLAND

CO FOUNDER / CEO

Brendan graduated with honours from University College Dublin Medical School in 2006. As an undergraduate, he completed a Bachelor of Medical Science as a concurrent degree and was awarded the Colman Saunders medal for Paediatrics. As a post-graduate, he became a Member of the Royal College of Physicians of Ireland and also a member of the Irish College of General Practitioners. Brendan was a BioInnovate Ireland Fellow 2014 during which time he developed his skills in identifying and determining opportunities in the lifescience and health technology landscapes. He learned to critically appraise very early stage development opportunities and de-risk potential investment opportunities. He became adept at conducting in-depth industry, market and company research; due diligence, including assessing the competitive landscape; critical analysis of business opportunity assumptions using his extensive medical knowledge base; and evaluating industry trends.

GERRY CLARKE

CO FOUNDER / CTO

Gerry has worked consistently in medical devices and diagnostics since the late 1970s, spending ten years in the USA industry sector during that time. He has had a number of increasingly responsible technical roles within Technicon, Sherwood Medical and C.R. Bard/Medtronic, most recently that of senior engineering manag- er within R&D at Medtronic. His expertise lies in process development, new tech- nology investigation and product design methodologies. He has several patents and trade secrets to his credit and has been charged with IP development at leadership level. A believer in team synergy, he is passionate about innovation that occurs at the boundaries of diverse disciplines. Gerry was a BioInnovate Ireland Fellow 2014, during which he further developed his skills at identifying unmet clinical needs and finding solutions through the application of experience and good engineering practice.

FIONA MANGAN

ENGINEER

Fiona graduated first in her class from Biomedical Engineering at NUI Galway. She has previously undertaken research at Georgia Institute of Technology, Atlanta. The research involved performing experiments on fresh porcine hearts, using SolidWorks for designing apparatus for artificial heart valve testing, data analysis and working with MATLAB software. Fiona has also worked in the R&D department at Boston Scientific becoming proficient with MIMICS and 3Matics software to evaluate patient specific data and create artificial 3-D calcifications. During the project she added to her extensive skill set including CAD design, finite element modelling, ISO standard compliance, report writing and team communication.

EndoLab is a world leader in the provision of technical services to develop and certify medical products.

EndoLab is a certified test laboratory according to ISO 17025, specializing in implant testing, computer simulation, and development of custom-made test set-ups including wear simulators. The InDx project will benefit from EndoLab’s more than 20 years of experience in implant testing, decreasing testing time and accelerating the InDx implant to market. EndoLab will lead the performance testing of materials and biomechanics to provide proof of biocompatibility, range of motion and wear, and Material Characterisation as required for the clinical investigations protocol approval in the First in Human Clinical Study and for the CE marking and FDA evaluation for Regulatory Approval.

MARTIN HINTNER

SENIOR PRINCIPAL TEST & ANALYSIS ENGINEER

Martin is a Senior Principal Test and Analysis Engineer. Throughout his career, Martin has demonstrated the ability to handle multiple projects and to quickly adapt to new challenges in a fast paced, multidisciplinary environment. Martin bring to the project a strong scientific background combined with a problem-solving attitude and hands on working style. Specialties and main interests include medical technologies, project management, experimental laboratory testing, test system design, software development, numerical analysis, and medical research. Martin received his Diploma of Medical Engineering in 2001 from the University of Applied Science Munich. He started working in biomechanics and biomaterials as a student in 1999 at EndoLab® GmbH. Since 2001, he is employed at EndoLab and was involved in the development of the EndoLab® hip simulator according to ISO 14242-1 and the EndoLab® knee simulator according to ISO 14243-1. Since 2014, he is a member of “Deutsches Institut für Normung (DIN /ISO)”.

MANUEL FERLE

HEAD OF RESEARCH AND DEVELOPMENT DEPARTMENT

Manuel Ferle is Head of the Research and Development Department at EndoLab®. Manuel has a strong scientific background in the field of joint biomechanics. Specialties and main interests include joint biomechanics, medical technologies, project management, experimental laboratory testing, test system design, software development, numerical analysis, and medical research. Manuel received a Bachelor in Mechanical Engineering and holds a Master in Biomedical Engineering. He is currently completing his doctoral thesis in the field of experimental joint kinematics at the Laboratory of Biomechanics and Biomaterials of the Hannover Medical School.

In the past seven years, Manuel worked on various biomechanical topics in the field of orthopaedics. His main focus was on robot-based in-vitro examinations of complex joints such as the knee and shoulder joint. Furthermore, Manuel worked on the development of multi-body simulations and on in-silico examinations of the knee joint. Within the framework of a collaborative research center, Manuel gained experience in development of shape memory based orthopaedic implant systems. His scientific activities resulted in numerous scientific publications in well-known journals

SANDRA WELCH

Sandra is Regional Director of Clinical EMEA for North American Science Associates Ltd (NAMSA) and is based in the Selby Office in North Yorkshire, UK. She has more than 20 years’ clinical and regulatory experience at NAMSA, setting up and managing multi-centre studies for both medical device and pharmaceutical companies in a number of therapeutic areas including but not limited to orthopaedics, cardiology, neurology, wound care, gynaecology and urology.

Sandra has oversight of all NAMSA Clinical Operations in the EMEA. She has also had the opportunity to speak at many European conferences, Institute of Clinical Research, NIHR and Medtech conferences about Clinical and Regulatory operations, including the European Medical Device Regulation (MDR).

Prior to joining NAMSA, Sandra was a qualified nurse (RGN) working in the specialty of Accident & Emergency.

DAN WHITTER

As the NAMSA Manager of Clinical Study Managers in the EMEA, Dan’s primary responsibility is the management of the Clinical Study Managers in Europe.  As a part of this role he is heavily involved in the quoting and contracts aspect of the business, and regularly presents at bid defences.

During his 13 year tenure at NAMSA, Dan has served in a range of clinical roles, from Clinical Research Associate to Clinical Project Leader, before moving into his current leadership role.  Through his time at NAMSA, Dan has been involved in all levels of studies, from monitoring to high level governance, across many different therapeutic areas including orthopeadic, cardiovascular, and wound management.

Dan has had the opportunity to speak at several global conferences about Clinical Operations in the Medical Device industry and has conducted training to Medical Device Modules for Universities in the UK. He has also delivered training sessions for manufacturers regarding the different types of Pre and Post market studies, including the Medical Device Regulation (MDR), that can be conducted in Europe, and how to perform these types of studies.

Previous to joining NAMSA, Dan had the opportunity to work for both AstraZeneca and Roche in various data management roles.  

MedVie provides strategic market access & business development services for medical device companies.

 

Medvie was established in Dublin, Ireland in 2014 to provide strategic market access and business development services for medical device companies. Medvie uses the latest design thinking methodologies to evaluate product-market fit and believes in building strong relationships with all healthcare stakeholders. The Medvie team have extensive experience in the healthcare field and a successful track record in the development and commercialisation of medical devices in the USA and Europe. The Medvie team includes highly experienced product managers, product designers and researchers providing a complete range of market services for our clients. The team has previously participated in EU research projects and has extensive experience in the project management of medical device development projects.

CRISTINA PURTILL

FOUNDER / CEO

Cristina Purtill (MBA) is the founder and CEO of Medvie. Cristina has fifteen years of experience in medical devices and IT businesses across Europe and the USA. She has a track record of successfully taking new products to global markets while working as a Global Product Manager with GE Healthcare in the USA and as an EMEA Healthcare Programs manager for Dell in Ireland. Cristina obtained an MBA from Georgia Institute of Technology in Atlanta, USA.

DONAL HEALION

HEAD OF DESIGN

Donal Healion has a B.Des in Industrial Design from NCAD and has held senior design, R&D and management roles in industry on an in-house and consultancy basis for over 15 years, delivering products to market from concept to launch. He completed a Masters in Medical Device Design in NCAD and his area of expertise is human factors and their influence on the design of products, environments and services leading to more intuitive and satisfying user experiences.

NEWS

All the latest news on the InDx project.

If you would more information about the InDx project, please send us an e-mail: info@indxproject.eu

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Project Coordinator Contact Details:

LOCI ORTHOPAEDICS

No. 4 Business Innovation Centre, National University of Ireland Galway, Ireland.
H91 H2Y0

info@lociorthopaedics.com

Project Manager Contact Details:

MEDVIE LTD.

Marine Court Centre Malahide, Malahide, Co. Dublin,
Ireland.
K36 VK53

info@medvie.ie

Loci Orthopaedics

MedVie Ltd.