Our People, Our Culture, Our Expertise - Driving Life Science Innovation.
ALLAN MACRAE / HEAD OF SOFTWARE
Allan is a distinguished software engineering leader, who boasts over two decades of hands-on leadership and cultivating internal software teams across diverse sectors including Medical Devices, Automotive, and Defence domains. His expertise shines in regulated environments, backed by hands-on familiarity with IEC62304, SaMD, cyber security requirements and numerous CE(EU), FDA(US), PMDA(Japan), Health Canada, and NPMA (China) regulated fillings.
Encompassing electronics, firmware, mobile, PC, cloud, and web software, Allan's mastery spans various life cycles and methodologies, driving innovation and underpinned by extensive IVD software development experience, including multiple successful NPD cycles for devices currently deployed in the field.
As the head of Software, Allan's responsibility covers all facets of medical device software, including the leadership of our software quality and data team.
Software Development, Software Lead, Systems Engineering, Device Leadership.
ANNIKA AINSLIE / SENIOR QUALITY ENGINEER
Annika is an experienced medical device professional within the industry. With over 20 years of Cross-functional experience across Research and Development, Statistical Support, and Quality Operations. Annika supports clients across both Development and Quality across process improvement and development projects.
Design Validation, Data Analysis, Process Improvement
DAVID HOWARTH / FOUNDER/ MANAGING DIRECTOR
David is a 20+ year veteran in medical device R&D, Quality, and Regulatory and is the founder and Managing Director of iDE8, in addition to his management and business development service.
David is a principal consultant within both development and quality management for our clients. In this role he assists in the continuous improvement projects and device product support.
Prior to founding iDE8 in 2015, David worked in corporate R&D within J&J as a development manager within a medical device start-up. David is a certified Six Sigma Black Belt with a wealth of experience in quality management, concept generation and device verification and validation.
Design Validation, Development Engineering, Development Lead, Quality Management.
JOHN GROCOTT / TRAINING CONSULTANT
With a career spanning over 30 years in the petrochemical and medical device industry, John has been coaching and teaching corporate teams since 2013.
He began working as an Energy for Performance coach within Johnson & Johnson across the EMEA and US regions and currently works closely with companies internationally to support new Health & Wellness Training.
John founded ENERJ in 2017 and is collaborating with iDE8 in our tailored training programs.
Health and Wellness, Risk Management
JULIE HOWARTH / OFFICE MANAGER
Julie is the quiet but vital force in the background who helps keep our office operational. In addition to being our Office Manager, she also takes care of payroll-related tasks and manages our human resources matters.
Julie has over 20 years of extensive experience in business operations and management and is also currently a Director within her family construction business.
Operations Management, Health and Safety, Human Resources
KAREN GRANT / SENIOR QUALITY ENGINEER
Karen joined iDE8 in November 2021 as a Senior Quality Engineer, coming from the medical device industry gaining experience across all aspects of Quality - Design, Operational, Supplier and Post market Launch.
With her wealth of knowledge on clinical operations, research and development, product management, Quality Lab Services and Products Lifecycles - Karen provides all aspects of quality support including CAPA's (Corrective Action Plans), NC's and Field Actions.
Karen is also an experienced Lead Auditor in both internal and supplier audits - giving her international experience throughout ISO13485:2016
ISO13485 Lead Auditor, Quality Systems, Supplier Quality, Industrial Statistics
LEE COX / PRINCIPAL QUALITY ENGINEER
Lee joined our company's quality department in 2019 as a principal quality ENGINEER. Lee is mainly responsible for providing senior-level management support and developing quality consulting solutions for our clients. As well as making sure that all of IDE8's internal systems meet the highest standards possible and are compliant with international standard ISO 13485:2016.
Over the course of his 20+ year career, Lee has worked in many different roles relating to quality such as supplier quality, process engineering, development quality control, and implementing electronic versions of quality systems; he sees himself more like an F1 pit crew - fixing any potential problem before it becomes too costly or even crippling to the company in question.
Quality Management, Quality Systems, Document Control
MALCOLM HAMER / ELECTRONICS CONSULTANT
A successful Electronics and Systems Design Engineer, with 20 years of experience in developing innovative technology products.
Malcolm is a subject matter expert in RF, EMC and Safety Testing, having designed many medical devices for world-wide release per international standards such as ISO 15197, 61010, 61326 60601 Radio Equipment Directive (EU), FCC (US), Bluetooth SIG, etc.
He has gained widespread industrial knowledge through his vast experience of the entire product life cycle - including requirement gathering; risk analysis; system reliability analysis plans and protocols; design characterization & verification plans & protocols; manufacturing data management programs (CIPs); and much more.
He excels at PCB Layout Engineering - even designing complex circuit boards containing analogue and digital electronics; with expertise at coding embedded software.
Malcolm also specializes in IoT solutions engineering - having completed countless wireless gateway designs to connect straight to Amazon Web Services or Microsoft Azure whenever necessary.
Electronic Engineering, Systems Design, Development Engineering
MICHAEL O'CONNELL/ TRAINING CONSULTANT
Michael is a certified J&J Master Black Belt who has worked for over 20 years in the Medical Devices industry where he became a great believer in the value and power of data when it is robustly collected and insightfully analyzed.
He has delivered training in Six Sigma and industrial statistics, as well as Health & Wellness and leadership skills for companies as diverse as surgical, sports car makers, food labeling, textiles, medical devices, healthcare, and national transportation.
Michael founded Aspire Highland Ltd in 2018 to deliver high-quality training in both face-to-face and virtual settings and works with iDE8 in delivering its training programs to medical device clients.
Six Sigma, Industrial Statistics, Health and Wellness
TRISH MACKAY / SENIOR DEVELOPMENT TECHNICIAN
With a career spanning over three decades in the medical industry. Trish has extensive experience working in laboratories –specializing in design verification testing of medical devices; quality engineering; product reliability testing; and test method validation. To work within NHS Scotland Pharmacy, Orthotics—including supporting Cancer or Covid-19 clinical trials.
Design Validation, Product Reliability, Test Method Validation