Australian Healthcare Solutions (AHS) is the Melbourne-area, device-only CRO a U.S. cardiovascular or respiratory founder finds when the search is AHS CRO Australia, Australian Healthcare Solutions clinical trials, or Australia medical device CRO and Mobius is already on the slide. The site is live at australianhealthcaresolutions.com.au (retrieved 23 August 2026). The product is a niche ANZ device consultancy: full-service trial operations plus field clinical support plus TGA / ARTG / reimbursement / market-development work after the study.
That is a serious Australia shortlist name. It is not a Latin American first-in-human operating system, and it is not a Phase I bed owner. This article keeps those distinctions clean. No named first-in-human press release was found on the public pages. No named sponsors are treated as facts here.
What AHS publishes
The homepage calls AHS an “Australian full service medical device clinical trial consultancy”: full-service CRO, local Australian medtech experts, “resourced to facilitate any stage of the commercial journey.” Service tiles: clinical trial services, field clinical support, international clients, regulatory, reimbursement, and strategic market development.
The clinical trial services page is explicit: AHS is “a niche medical device Contract Research Organisation (CRO) based in Australia,” covering Australia and New Zealand. The menu is flexible — full management or a custom suite — and lists project management; KOL and site identification; full ethics (HREC) submissions and amendments; TGA–CTN regulatory management; site initiation and training; TMF; patient and site binders; CRFs; field clinical support; sponsorship facilitation; monitoring; adverse-event management; subject recruitment; and close-out.
The same page is the FIH sentence that puts AHS on this map: AHS is “equipped to run small, single-site, first-in-human trials through to multi-centre trials within Australia and New Zealand,” and to run the Australian arm of a multi-national trial. Therapeutic relationships named: respiratory, cardiology, cardiac surgery, vascular, thoracics, and interventional radiology. Quality is framed as GCP and ISO 14155.
The about page adds that AHS works with domestic and international clients and has “particular experience in partnering with medical device clients based out of the USA.” Founding is on the people page, not as a corporate-history essay: Matt Godden “founded Australian Healthcare Solutions after leaving the corporate sector in 2008.” His last corporate role is published as Director of Medtronic Australasia’s Cardiovascular business, after more than 25 years in healthcare in Australia and Asia-Pacific, including a regional strategic market-development role at Medtronic. MBA (Mt. Eliza), Bachelor of Education (La Trobe), Diploma of Applied Science (RMIT).
Also named on our-people: Cath Martland, Marketing Director (healthcare and nutrition marketing; postgraduate marketing, Masters in Nutrition and Dietetics, science degree). Consultants: Arianne Jolly, Clinical Trial Consultant (device and pharma research since 2001; independent consulting from November 2013 — protocol, ethics, monitoring, CRF, QA, GCP training); Kea Imgraben, Regulatory Consultant (device/IVD RA across 44 countries since 1996; prior Telstra Business Woman of the Year, South Australia, private-sector category, 2002).
Competitive research places the firm in Melbourne (Camberwell / Abbotsford, Victoria). The about page says “based in Australia” without reprinting a street address in the fetch used here.
No named sponsor FIH press release was found on the public pages reviewed. The FIH claim is a capability sentence. Treat it as such until a de-identified TMF shows up in the RFP.
Where an ex-Medtronic ANZ device CRO is the right tool
Hire AHS when the protocol is a respiratory, structural, vascular, cardiac-surgery, thoracic, or IR device that needs ANZ hospital sites, field clinical people in the lab, and a partner who will still be in the room for ARTG listing and reimbursement after the last follow-up. That commercialisation overlay is closer to a market-access shop than a Phase I unit. U.S. sponsors are an explicit customer type on the about page.
Do not hire AHS as a substitute for the Australia-versus-Latin-America cash conversation. CTN, HREC, and ISO 14155 are country and quality features. The 43.5% offset is an entity feature. AHS can run the trial. AHS cannot make a Delaware C-corp into an eligible Australian R&D company by signing a CRO contract.
On the Australia device slide, put AHS next to Mobius (the public EFS-to-pivotal story), Ascend (2024 device-only), and CROW Clinical (field clinical engineers). They are not interchangeable. Mobius publishes named device history. AHS publishes a Medtronic-cardiovascular operator and a first-in-human-through-multicentre sentence. CROW publishes engineers in the lab.
Australia cash is not a 43.5% price cut
Reuse only, no new table. Sources: bioaccess® vs Australia, rebate math, and the live Mobius pillar.
- On a gross, cash-contracting basis, Latin America runs, in bioaccess®’s program experience, about 35–45% below Australia (varies with design and FX).
- A fully captured 43.5% refundable offset for groups under A$20 million aggregated turnover narrows the effective gap to roughly 5–15%. In some programs it can close or reverse the gap.
- You generally need an eligible Australian company. You fund the gross now. Cash returns after year-end lodgement.
- End-to-end start-up is broadly comparable once Australian site governance is counted. CTN is not the whole clock.
bioaccess® contracts and starts in Latin America with no foreign subsidiary. If the rebate is how the round was sold and counsel will form the entity, Australia can win — with AHS or Mobius as the ANZ prime. If the entity is unscoped, the rebate is not in the cash forecast.
What bioaccess® is selling instead
bioaccess® is The First-in-Human CRO. Co-founded 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). IMH ASSETS CORP. Miami HQ, 1200 Brickell Ave, Suite 1950 #1034. Offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. FIH-only since 2010. 50+ pre-qualified sites, 19 countries; 50+ FIH/EFS supported; 50+ clients (about page). ISO 14155. English 21 CFR 812.28 data room. U.S. Eastern-time sponsor desk.
Colombia is not retired. As of 23 August 2026 we still run clinical trials in Colombia, keep a local entity and office, manage INVIMA in-country, and carry 30+ historical FIH device studies and 20+ sites in Bogotá, Cali, Medellín, and Barranquilla. See CRO in Colombia. Commercial registro sanitario is a separate live service.
AHS sells ANZ device operations plus Australian market access. bioaccess® sells first-in-human execution in Latin America plus LATAM sanitary registration through its own holders. Those can be sequential: generate human data where the cash and volume work, register later where you will sell. Mixing them into one Australia CRO contract is how founders discover that ARTG listing did not produce an INVIMA number.
AHS vs bioaccess® — device FIH comparison
| Dimension | Australian Healthcare Solutions (AHS) | bioaccess® |
|---|---|---|
| Public age | Founded 2008 (Godden, after Medtronic Australasia CV) | Founded 2010 |
| Home geography | Australia / ANZ; competitive map: Melbourne | Miami HQ; local LATAM entities including Colombia |
| Mix | Device only; FIH through multi-centre ANZ; TGA/ARTG + reimbursement | FIH/EFS devices (also biopharma / radiopharma FIH) |
| Named FIH sponsors | None on public site | Published case studies on bioaccessla.com |
| Leadership (site) | Matt Godden, Strategic Director; Cath Martland; Arianne Jolly; Kea Imgraben | Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill |
| Quality language | GCP + ISO 14155 | ISO 14155 → 21 CFR 812.28 (FDA decides) |
| Gross cash | Australia cost base; rebate only with an eligible AU entity | ~35–45% below Australia on gross, program experience |
| After the trial | ARTG, reimbursement, strategic market development in Australia | Live multi-country LATAM sanitary registration / holder |
| Colombia | Not a Colombia CRO | Still executing; local entity; INVIMA in-country |
How to keep AHS on the list without confusing the job
If ANZ is locked, the indication sits in AHS’s published therapeutic list, and you want field support plus a reimbursement conversation, AHS belongs on the RFP next to Mobius. Ask for a named or de-identified device FIH: class, implant versus non-implant, n, ISO 14155 monitoring plan, English TMF, and FDA-file use. If that package exists, they can be the ANZ prime.
If the number that matters is gross cash this quarter, you will not form an Australian company, or you need Latin American surgical volume and a Miami desk — including Colombia when that is the right file — put bioaccess® in the prime column. Request a proposal at contact.
FAQ — AHS Australia device CRO
Does AHS run first-in-human device trials?
The clinical-trial-services page says yes: single-site FIH through multi-centre ANZ, plus Australian arms of multi-national trials. Named FIH press is not on the public site.
Who leads AHS?
Matt Godden, Strategic Director and founder (ex-Medtronic Australasia Cardiovascular). Cath Martland is Marketing Director. Arianne Jolly and Kea Imgraben are named consultants.
Is AHS cheaper than Latin America after the R&D tax incentive?
The incentive is a country rule, not an AHS discount. On cash out the door, Latin America is typically 35–45% lower in bioaccess®’s program experience. The rebate narrows that only if you fully capture 43.5% through an eligible Australian company. See the rebate math.
AHS or Mobius?
Both are Australian device specialists founded in 2008. Mobius publishes Tendyne and a named CT.gov sponsorship. AHS publishes Medtronic-cardiovascular leadership and a FIH-through-multicentre sentence plus ARTG/reimbursement. Diligence the TMF, not the founding year.
Does bioaccess® still run first-in-human trials in Colombia?
Yes. As of 23 August 2026 we still run clinical trials in Colombia. INVIMA clocks are managed in-country.
Competitor facts from australianhealthcaresolutions.com.au pages listed above, 23 August 2026. Melbourne placement from competitive map. bioaccess® facts from bioaccessla.com. No invented emails, sponsor names, or day-count medians.