Starband: a full helmet range to Saudi approval in six months
- Products: the full Starband range of cranial remoulding orthoses (CROs) and post-surgical protective helmets
- Classification: Class II medical devices
- Market: Saudi Arabia, SFDA Medical Device Marketing Authorisation (MDMA)
- Challenge: the original technical file for each helmet design was weak and not ready for SFDA review
- Outcome: technical files strengthened design by design, and every helmet in the range registered with the SFDA within six months
Landis: non-medical equipment cleared for import into Saudi Arabia
- Products: Landis equipment, classified as non-medical
- Market: Saudi Arabia
- Scope: SASO conformity and SABER registration, supported by CSA equipment testing and certification
- Outcome: registrations in place for import into the Kingdom
TurboMed Orthotics: ISO 13485 to Saudi market approval in 2 months
- Product: External ankle-foot orthosis (AFO)
- Markets: Canada → Saudi Arabia
- Scope: ISO 13485 certification with TÜV Austria, then SFDA Medical Device Marketing Authorization (MDMA)
- Outcome: both delivered within two months, on a lean, fixed budget
ISO 13485, United Kingdom: a stalled project certified in six months for a tenth of the cost
- Scope: ISO 13485 quality management system certification
- Challenge: the project had already cost $300,000 over 12 months without reaching certification
- What we did: took over the project, reset the plan and managed it through to the certification audit
- Outcome: ISO 13485 certification within six months, at a cost of $30,000
Commercial results
- Rehabilitation device manufacturer grown from $3m to $20m revenue in four years
- $25m US sales pipeline for a 3D-printing start-up within six months of market entry
- $10m revenue at 65% gross margin within three years, with a five-person sales leadership team for Middle East rehabilitation
