Legislators, Regulators and the Media move fast. If the Ownership of Med-Tech SMEs stay fragmented, the next rule change could shut you out before you know it.  With years of combined experience in the Australian Med Tech industry, dealing with these threats,  here's what we learned that could  fatally damage your business.

• Sweeping legislative reform of Therapeutic-Goods Laws that could impose costly new conformity-assessment fees—or remove entire product classes overnight.

• Mandatory industry codes drafted by Large International Multinational Corporations lock in their own processes with regulators and can leave SME stakeholders scrambling to retrofit at ruinous cost.

• Reputational  fallout from rogue suppliers generating sensational media headlines, triggering blanket crack-downs that punish the entire sector and hit SME suppliers the hardest.

• Procurement Gate keeping—State and Federal buying panels raising turnover or insurance thresholds that quietly exclude smaller manufacturers.

• Import dumping & offshore competition with inferior products drive price wars while local compliance costs climb.

• Blanket Cyber-security and Data-Sovereignty mandates designed for large Multinational Corporations with million-dollar penalties for non-compliance can have unintended consequences for SME's in the sector.

• Environmental, Social & Governance (ESG) reporting obligations that can become de-facto licence-to-operate requirements which can be outside the capacity of SME's in the sector to fulfil in the required format - one size does not fit all. .

• Global standard harmonisation (e.g. EU MDR/IVDR) forcing costly re-certification of existing devices to retain market access.

• Supply-chain resilience rules rewarding vertically-integrated giants and sidelining niche specialists.

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