Medtech & Biotech Consultancy · Australia

Getting your
medical technology
to market.

Hands-on product R&D leadership, regulatory strategy, and investor-ready operational expertise for medical device and biotech companies — from first prototype to market launch and capital raise.

Discuss Your Project View Case Studies
30+
Years industry experience
25+
Products brought to market
TGA · FDA · CE
Regulatory frameworks served
R&D to Capital Raise
End-to-end capability
25
01

The gap NuAge fills

Most medtech startups have brilliant science and stall on the operational machinery or strategic input needed to commercialise it.

Regulatory submissions that stall. Quality systems that satisfy auditors but obstruct your team. R&D programmes that drift without disciplined program management. Investors asking due diligence questions that your team cannot answer with confidence.

NuAge Technologies plugs directly into your operation to resolve these bottlenecks — bringing the hands-on product development experience and executive capability your company needs, without the overhead of a permanent hire.

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Genuine R&D depth — not just oversightWayne has designed and developed medical products from the ground up. He understands the science, the engineering trade-offs, and the path from concept to verified, validated product.
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You work with the expert, not a delegateWayne Jensen leads every engagement personally. No handoff to a junior consultant after the pitch.
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Investor-ready operational capabilityFrom building the technical credibility that survives investor due diligence, to presenting a defensible development roadmap — NuAge supports capital raise readiness as a core service.
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Multi-jurisdictional regulatory experienceTGA, FDA, CE/MDR — practical submission and compliance experience across major markets, from strategy through to approved product.
02

Services

"Our science is strong but we do not have the product development experience to take it further."
Product R&D Leadership
Hands-on leadership of product research and development programmes — from technology assessment and feasibility through iterative development, design freeze, and verification. Wayne brings direct experience developing and commercialising medical products across multiple technology platforms.
R&D · Product Development
"We are preparing for a capital raise and investors are asking questions we cannot answer with confidence."
Capital Raise & Investor Readiness
Support for medtech and biotech companies preparing for seed, Series A, or Series B raises. Building the technical and operational credibility that withstands investor due diligence — regulatory strategy, development roadmaps, risk registers, manufacturing plans, and milestone frameworks that give investors confidence in your execution capability.
Capital Raise · Investor Readiness
"We are burning runway while investors ask about our regulatory pathway."
Strategic Advisory
Operational and business strategy for medtech and biotech companies. Cut through noise to prioritise what actually moves the needle toward commercialisation and investment milestones.
Strategy
"Our design history file is a mess and we are nine months from submission."
ISO 13485 Design Control
Implementation and management of ISO 13485 and ISO 9001-compliant R&D and design control processes. Built into how your team works — not layered on top as an administrative burden.
ISO 13485 · Quality
"We do not know what a regulator will want to see — and we are guessing."
Regulatory Submission Support
Verification and validation strategy and execution for TGA, FDA 510(k), and CE/MDR submissions — planned from day one, not retrofitted. Practical experience across multiple successful regulatory submissions in Australia, the US, and Europe.
TGA · FDA · CE/MDR
"We need to manufacture but do not know whether to build in-house or outsource."
cGMP Manufacturing & QC Setup
Fit-for-purpose cGMP manufacturing and quality control — whether setting up in-house operations or selecting, qualifying, and managing a contract development and manufacturing organisation (CDMO).
Manufacturing · cGMP · CDMO
03

Case Studies

Client details anonymised.
Monitoring DeviceFDA 510(k)Series A

A monitoring diagnostic device startup had received a rejected FDA 510(k) submission, with capable teams but no program management discipline and unresolved product performance challenges.

Embedded as fractional COO for six months. Assessed the strategic approach, introduced structured program governance, rebuilt the work program and development timeline, instituted milestone reviews, and established a clear communication cadence with the board and investors.

Outcome
Redefined product development strategy with the executive team, resulting in reprioritised development activities toward a more viable commercial application. Board confidence in execution restored.
Life SciencescGMP ManufacturingSeed Stage

A seed-stage life sciences company had multiple diagnostic and pharmaceutical products in development but no systematic R&D documentation process or clear pathway to regulatory-compliant manufacturing.

Embedded as fractional COO. Reviewed documentation processes and implemented an R&D procedure enabling systematic data collation, analysis, and reporting. Extracted reports from research institutions to establish target product requirements, enabling manufacturing and QC technology transfers to cGMP-compliant CDMO facilities.

Outcome
R&D procedure implemented for streamlined, regulatory-compliant documentation. Technology transfer of manufacturing and QC operations completed for multiple product lines to cGMP-compliant CDMO facilities.
MedtechISO 13485Pre-IPO

A pre-IPO medtech company needed to bring in-house manufacturing, QA, product development, and clinical teams under control — and achieve ISO 13485 certification ahead of an FDA regulatory submission.

Led in-house manufacturing, QA, product development (software and hardware), and clinical teams. Conducted a full gap analysis of design control documentation against ISO 13485 requirements, rebuilt the DHF structure, and oversaw V&V protocol development and execution including hardware verification and clinical validation studies. Researched and advised on the FDA regulatory submission pathway.

Outcome
ISO 13485 certification achieved. FDA regulatory strategy and submission pathway scoped. Product development pathway, milestones, and lead times mapped and documented.
Biotech SpinoutInvestor ReadinessPre-seed to Seed

A university spinout with novel biomarker technology needed to build an investor-credible development roadmap before their seed raise.

Provided strategic advisory support to define the regulatory strategy, R&D milestones, and manufacturing pathway. Supported the team in presenting a technically credible operational plan to investors and refining their product development timeline.

Outcome
Regulatory strategy and development roadmap completed and presented to investors. Company progressed to seed raise.
04

About Wayne Jensen

Wayne Jensen PhD, Founder and Director of NuAge Technologies, medtech and biotech consultant Australia
Wayne Jensen, PhD
Founder & Director · NuAge Technologies

Over 30 years building medical products — at the bench, on the production floor, and in the boardroom.

Wayne Jensen founded NuAge Technologies to bring genuine product development experience to medtech and biotech companies that need more than strategic advice — they need someone who has actually designed, developed, and commercialised medical products, and who understands the science, engineering, and regulatory demands that entails.

His career spans the full arc of medical technology: hands-on R&D and product design, program and project management, manufacturing scale-up, quality control and quality assurance, regulatory submissions, and executive leadership. Having occupied roles from the laboratory bench to the C-suite, Wayne brings an unusually integrated perspective to the operational and technical challenges that most commonly derail early-stage companies.

With more than 25 products brought to domestic and international markets across medical devices, diagnostics, biotech, and combination products, Wayne offers clients access to proven, practical knowledge — built through direct experience, not observation. He has successfully navigated TGA, FDA, and CE/MDR regulatory environments across multiple product categories, and has supported companies from pre-seed through to pre-IPO in building the operational foundations and investor credibility they need to raise capital and grow.

  • 30+ years in medtech and biotech product research, development, and commercialisation
  • 25+ products brought to market — medical devices, diagnostics, biotech, combination products
  • Hands-on R&D leadership from concept through design freeze, verification, and validation
  • Regulatory submissions across TGA (Australia), FDA (USA), and CE/MDR (Europe)
  • ISO 13485 and ISO 9001 QMS implementation, management, and certification
  • Capital raise and investor readiness support — seed through Series B
  • cGMP manufacturing setup — in-house operations and CDMO selection and management
  • Roles spanning bench-level R&D, production floor, program management, and C-suite
05

How we work together

06

Start a conversation

The best way to determine whether NuAge Technologies can help is a direct conversation. There is no commitment, and no pitch — just a practical discussion about where you are and what you need.

✉
wayne@nuage-technologies.com
☏
+61 400 898 890
in
linkedin.com/in/wayne-a-jensen
in
NuAge Technologies on LinkedIn

Based in Australia. Serving clients nationally and internationally.

What to expect

When you reach out
  • A response within one business day
  • An initial 30-minute call to understand your situation and needs
  • An honest assessment of whether and how NuAge can help — no overselling
  • If there is a fit, a proposed engagement structure and scope within one week
  • If there is not, a candid recommendation of what kind of support you actually need
Email Wayne directly Connect on LinkedIn