IMPLANT3D INC.

Low-cost, on-demand patient specific implants

THE MASSIVE PROBLEM FACING HEALTHCARE TODAY!

The cost of healthcare is high and continues to rise dramatically, and surgical implants represent a significant part of the cost. Some incredible facts:

  • The US spinal implant market exceeded $6.8 billion in 2016, a staggering 30 times larger than it was in 1994 1

  • Hospitals routinely pay about $8,000 for hip implants that cost about $350 to manufacture 2

At the same time reimbursement rates are dropping.

  • Reimbursement for orthopedic procedures has steadily decreased, with the most rapid decrease seen in adult reconstruction 3

  • After correction to 2020 dollars, average reimbursement for health care procedures for orthopedic trauma decreased by 30% between 2000-2020 4

  • The advent of bundled payments provides hospitals a huge incentive to lower costs 5

1 Pahlavan S, Berven S, Bederman SS. Variation in costs of spinal implants in United States academic medical centers. Spine (Phila Pa 1976). 2016;41(6):515-521

2 Elizabeth Rosenthal, “In Need of a New Hip, But Priced Out of the U.S.,” New York Times, August 3, 2013

3 Eltorai AEM, et al. Trends in Medicare Reimbursement for Orthopedic Procedures: 2000 to 2016. Orthopedics. 2018 Mar 1;41(2):95-102

4 Haglin, J.M., et al. (2020) Declining Medicare Reimbursement in Orthopedic Trauma Surgery 2000- 2020. Journal of Orthopaedic Trauma

5 Jaimy Lee, “Bundled Payments Give Surgeons a Powerful New Incentive to Reduce Costs”, Modern Healthcare, March 1, 2014

WHY ON-SITE MANUFACTURING?

Improved Outcomes

Provides easy access to patient specific implants, many of which have been shown to be associated with better clinical outcomes, simplified surgical procedures and reduced recovery times.

Simplified Workflow

With the manufacturing, operations and clinical support so close, the entire surgical team has more control and access, resulting in an improved workflow.

Surgical teams can communicate faster and be more engaged while being supported by a clinically trained lab manager.

Generate Revenue

By providing the on-site space, hospitals are part of the manufacturing process and generate revenue through rent.

With manufacturing, operations and clinical support in a single location, expenses can be consolidated and optimized, resulting in lower overall costs.

OUR PROCESS

We partner with hospitals to open and manage an easily accessible, on-site 3D Lab close to the Operating Room

Hospital commitments:

  • Lease lab space near Operating Room to IMPLANT3D

    • The lab space will be an IMPLANT3D facility - this is critical to minimize hospital's exposure to regulatory risk

  • Commit to using minimum number of implants

  • Exclusivity - no other competing implant manufacturing lab on-site


IMPLANT3D commitments:

  • Provide surgical planning software (free access to surgical team) and high quality, safe, FDA cleared, reimbursable implants for use in surgery

  • Manage all FDA submissions, registrations, audits, etc.

  • Provide clinical training and support for each case (design, planning and intraoperative)

TECHNOLOGY

Surgical Planning Software

  • Step by step surgical planning software, with customized 3D visualizations and manipulation tools, specifically tailored for the selected implant type and design.

  • Remote access feature enables planning and clinical support from lab manager or customer support team

  • Cloud enabled software allows for communication of surgery plan among surgical team and lab manager to facilitate better intra-operative support for the surgeon

On-site Manufacturing Lab

  • FDA registered facility, 21 CFR 820 compliant Quality System

  • Latest 3D printing technology, optimized for on-site manufacturing

  • Easily accessible by surgical team to better understand surgery plan and thus better intra-operatively support the surgeon

  • Clinically trained lab manager (usually a former implant sales rep) to further provide planning and intra-operative support