Medical Device Engineering & Advisory

Ideation
to Post
Market.

Deep engineering expertise across additive and subtractive manufacturing — paired with fractional executive leadership to bring your medical device from concept to cleared.

Brad Coale — NXWRX Founder

Brad Coale

Founder & Principal Consultant

FDA
Regulatory Experience
C-Suite
Fractional Support
End-to-End
Device Development
The NXWRX Philosophy

The early stages are
where success is defined.

Most device programs don't fail at launch — they fail in the decisions made years earlier. That's where we work. Bringing precision engineering and seasoned leadership to the moments that matter most.

Start Early. Start Right. →
Ideation
Development
Clearance
Post-Market
We work across every stage
Market Expertise

Built for
MedTech.

From first sketch through post-market surveillance — the manufacturing depth and engineering breadth to take your device all the way.

Additive MfgSubtractive Mfg BiomaterialsISO 13485 FDA 510(k)Design Controls
Discuss Your Program

Additive Manufacturing

  • Laser & eBeam sintering
  • Metals, alloys, porous structures
  • FDM (In-house)
  • SLA (In-house)
  • Rapid prototyping & iteration
⚙️

Subtractive Manufacturing

  • Swiss precision machining
  • 5-Axis CNC
  • Turn & Mill
  • Injection Molding
  • Polymers & elastomers
🔬

Materials Expertise

  • Titanium alloys
  • Stainless Steels
  • Biomaterials
  • Porous metal scaffolds
  • Textured bone blocks
📋

Regulatory & Design

  • FDA 510(k) strategy
  • Design controls & DHF
  • Risk mgmt (ISO 14971)
  • DFM & design transfer
  • Post-market support
Executive Support

Fractional COO/CTO
on Demand.

Engineering leadership doesn't have to be a full-time hire. NXWRX embeds as your fractional executive — supporting current operations and building the infrastructure for future growth.

Whether you need someone to own the technical roadmap, lead regulatory submissions, or scale your manufacturing ops, we bring C-suite bandwidth without C-suite overhead.

Fractional CTO Fractional COO VP Engineering Technical Advisor
01

Strategic Technical Leadership

Own the engineering roadmap, technology decisions, and R&D direction aligned to your commercial milestones.

02

Operational Excellence

Build and optimize your design, quality, and manufacturing operations for scale — from team structure to process infrastructure.

03

Investor & Board Readiness

Technical due diligence support, investor communications, and milestone planning that instills confidence at every raise.

Brad Coale

Brad Coale

Founder & Principal Consultant

About NXWRX

Engineering
Background.
Innovation
Focus.

Brad Coale combines a deep engineering background with a focus on innovation and product development within the medical device field. His portfolio includes involvement in numerous patented inventions.

From advanced surgical instrumentation for ACL reconstruction procedures to implants utilizing porous metal and textured bone blocks — Brad is driven to explore new applications of technology and bring to market advancements that benefit patients and the medical community alike.

Book a Call with Brad
Proven IP

Patent Portfolio.

21+ granted patents and applications across orthopedic implants, surgical instrumentation, biomaterials, and bone reconstruction — assigned to industry leaders including Zimmer, Biomet, Zimmer Knee Creations, EBI, IMDS, and Taq Ortho.

View All on Google Patents →
US 12,364,520
Bone Insert Augment and Offset Device
Latest granted patent — a bone insert with a convex cap and elongated stem seated against exposed bone, designed for augmentation and precise offset in reconstructive implant surgery.
Taq Ortho, LLC 2025
USPTO Record →
US 11,666,447
Bone Implant Augment and Offset Device
A bone insert with a cap of micro struts and an elongated stem inserted into host bone — designed to augment and offset bone implants for improved fixation.
Taq Ortho, LLC 2023
USPTO Record →
US 2023/0320767
Bone Insert Augment and Offset Method
Method for placing a bone insert with a convex cap and elongated stem into a host bone — the barrier seats against exposed bone for precise augmentation and offset positioning.
PrezzFit LLC 2023
USPTO Record →
US 11,678,917
Bone Insert Augment and Offset Method
Granted method patent for a bone insert with cap micro struts and stem micro struts inserted into host bone — providing augmentation and angular offset for implant positioning.
Taq Ortho, LLC 2023
USPTO Record →
US 2021/0008247
Curable Calcium Phosphate Compositions for Porous Structures
Curable calcium phosphate compositions for use with porous structures — methods and compositions for enhanced bone integration in porous implants.
Zimmer Knee Creations 2021
USPTO Record →
US 10,675,074
Porous Fixation Devices and Methods
Porous screws and pegs formed through additive manufacturing with improved porosity for bone ingrowth — including porous titanium pegs and screws.
Zimmer, Inc. 2020
USPTO Record →
EP 2,675,490
Non-Resorbable Polymer–Ceramic Composite Implant Materials
Orthopedic composite material derived from coral via hydrothermal conversion to calcium phosphate, forming a porous coralline structure for implant use.
Biomet Manufacturing 2018
USPTO Record →
US 2018/0146997
Method and Apparatus for Delivering Bone Cement
A bone cement delivery system with a dispenser housing, plunger, and pressure release mechanism — enabling controlled cement delivery in orthopedic procedures.
EBI, LLC 2018
USPTO Record →
US 2018/0008415
Shapeable Porous Metal Implant
Shapeable porous metal implants and methods — a shell of highly porous metal material (55–90% porosity) formable for use across various orthopedic procedures.
Zimmer, Inc. 2018
USPTO Record →
US 9,629,646
Curved Burr Surgical Instrument
Arthroscopic tissue resection device with an hourglass-shaped burr matched to natural bone curvature, featuring a depth-stop window for precision in hip FAI surgery.
IMDS Corporation 2017
USPTO Record →
US 2016/0206432
Implant Including Cartilage Plug and Porous Metal
An orthopedic implant with a porous metal base to encourage bone ingrowth — combined with a cartilage plug component for osteochondral defect repair.
Zimmer Biomet 2016
USPTO Record →
EP 2,811,922
Curved Arthroscopic Burr (European)
European patent for the curved arthroscopic burr — an hourglass-shaped tissue resection device with depth-stop window and protective guard for precision arthroscopic surgery.
IMDS Corporation 2014
USPTO Record →
US 8,343,229
Textured Bone Block Implants
Implantable pliable bone blocks of cortical bone with slot features on opposing faces to facilitate integration and fixation in reconstructive procedures.
EBI, LLC 2013
USPTO Record →
US 2013/0211408
Curved Arthroscopic Burr & Measurement Instrumentation
A tissue resection device with off-axis torque couplings and angled cutting inserts arranged in sequence — enabling curved arthroscopic resection with precise depth control.
IMDS / Jens Kather 2013
USPTO Record →
WO 2013/086440
Shoulder Arthroplasty (International)
International PCT patent for a shoulder prosthesis system for replacement, revision and repair — implants fixed in superior-inferior and anterior-posterior orientations forming an X-shape construct.
Cleveland Clinic Foundation 2013
USPTO Record →
US 2012/0059416
Intra-Operative ACL Graft Instrumentation
A line lock system for ACL graft fixation — a plate with passageways enabling knotless one-way fixation of graft filaments during anterior cruciate ligament reconstruction.
MedicineLodge / IMDS 2012
USPTO Record →
WO 2012/047925
Intra-Operative ACL Graft Instrumentation (International)
International PCT application for the knotless ACL line lock graft fixation system — a plate with one-way filament passageways eliminating the need for surgical knots.
MedicineLodge / IMDS 2012
USPTO Record →
USD 635,248
Bone Cement Dispenser (Design)
Ornamental design patent for a bone cement dispenser — protecting the distinctive visual design of a precision surgical delivery device.
EBI, LLC 2011
USPTO Record →

21+ patents and applications across porous metal implants, bone reconstruction, arthroscopic instrumentation, ACL fixation, shoulder arthroplasty, biomaterials, and bone cement delivery — assigned to Zimmer, Biomet, EBI, IMDS, Cleveland Clinic Foundation, Taq Ortho, and more. This is the depth of engineering knowledge Brad brings to every engagement.

Work With Brad →
Email
🌐
Website
📍
Availability
Nationwide & Remote Engagements