Twenty-four pain points, following the distributor value chain from principal to paid invoice. Severity reflects the cost when it goes wrong: the licence, patient safety or cash. Pick an area to focus the list.
P1Critical
SAHPRA ISO 13485: a working, auditable QMS is now a licence condition
Where it bitesRegulatory
What it costsLicence renewals and amendments blocked; certification body fees for re-audits
P2High
Complaints and adverse events handled by email, vigilance timelines missed
Where it bitesPost-market
What it costsSAHPRA non-compliance; principal relationship at risk
P3High
CAPAs and audit findings raised but never verified or closed
Where it bitesQuality
What it costsRepeat findings; failed surveillance audits
P4High
SOPs and IFUs uncontrolled; obsolete versions in circulation
Where it bitesQuality
What it costsAudit findings; the wrong IFU shipped with a device
P5Medium
Principal and service-supplier evaluations and quality agreements lapse
Where it bitesPurchasing
What it costsAudit findings; principal audit failures
P6High
Licences, permits, registrations and agreements tracked in someone’s calendar
Where it bitesRegulatory
What it costsShipments stopped; loss of a product line
P7Critical
Recalls and field safety notices: every affected unit can’t be found fast
Where it bitesPost-market
What it costsPatient safety; SAHPRA and principal penalties; reputation
P8Critical
Lot and serial traceability broken across paper, ERP and delivery notes
Where it bitesTraceability
What it costsRegistration errors; recall blind spots
P9Critical
Consignment stock at hospitals: no live view, slow counts, shrinkage, disputes
Where it bitesInventory and cash
What it costsWrite-offs; capital tied up in stock nobody can see
P10High
Loan sets and instrument trays: booking, sterilisation turnaround, missing items
Where it bitesCase logistics
What it costsCancelled cases; lost instruments
P11High
Expiry write-offs and short-dated deliveries
Where it bitesInventory
What it costsDirect write-off; hospital complaints
P12Medium
Storage conditions and temperature monitoring kept on paper
Where it bitesWarehouse
What it costsQuarantined stock; audit findings
P13High
Case coordination: surgeon schedule, device on site, rep in attendance
Where it bitesCase management
What it costsPostponed surgeries; overtime and couriers
P14High
Medical scheme pre-authorisation: slow, documents missing, rejections untracked
Where it bitesCases and revenue
What it costsDelayed cases; unpaid cases
P15Critical
Usage-to-invoice leakage: implants used in theatre billed late, wrong, or never
Where it bitesRevenue
What it costsDirect revenue loss — often the largest hidden cost
P16High
Debtors: hospital groups and provinces pay slowly; disputes over usage
Where it bitesCash
What it costsWorking-capital squeeze
P17High
Tenders and contract pricing: state contracts, hospital group price lists, expiring prices
Where it bitesCommercial
What it costsLost tenders; margin leakage on wrong prices
P18Medium
Rep activity, specialist coverage and ethical-marketing compliance
Where it bitesSales
What it costsWasted field time; code-of-conduct exposure
P19High
Imports: principal orders, forex, customs, lead times, backorders
Where it bitesSupply
What it costsStock-outs; margin swings on the rand
P20High
No single view of the business; month-end Excel packs
Where it bitesManagement
What it costsLate decisions; owner dependency
P21Medium
Capital equipment service and calibration tracking
Where it bitesService
What it costsEquipment down in theatre; lost service revenue
P22Medium
Staff and HCP training records scattered
Where it bitesQuality and sales
What it costsAudit findings; uncertified case support
P23High
POPIA: patient and HCP information held in spreadsheets and WhatsApp
Where it bitesData protection
What it costsInformation Regulator exposure
P24High
Double capture between spreadsheets, the ERP and principals’ portals
Where it bitesEverywhere
What it costsErrors; admin headcount