Artificial Intelligence and Digitizing

of the Supply Chain

FACULTY DISCLOSURE

The faculty reported the following financial relationships or

relationships to products or devices they or their

spouse/life partner have with commercial interests related

to the content of this CE activity:

Michael Louviere: Nothing to Disclose

Robert Wesley: Nothing to Disclose

3D Printing in HealthCare

Robert Wesley

3D Printing Engineer

St. Louis Children's Hospital, BJC HealthCare

Short Biography• Tennessee Tech University 2013, BS Chemical Engineering

• North Carolina A&T State University 2015, MS Bioengineering

• Nicklaus Children’s Hospital 2015-2017

• St. Louis Children’s Hospital 2017-present

• Nicklaus Children’s Hospital-Consultant 2017-present

• 3DHeals LLC- Consultant 2018-present

• Previous consultant “gigs”

–Monroe Carrel Jr. Children’s Hospital at Vanderbilt

–Levine Children’s Hospital, Carolinas HealthCare

BJC HealthCare• 13 hospitals

• 30,000+ employees

• Covering 6,500 sq mi

• Partnered with Washington University in St. Louis School of Medicine

• 1 centralized medical 3D printing center on main campus

3D Printing: What is it? What is its history in healthcare?• Three-dimensional (3D) printing is a manufacturing method in which objects

are made by fusing or depositing materials layers to produce a 3D object.

Benefits• Better preparation for surgical teams

• Improved patient outcomes

• Reduced operating room time

• Improved patient communication

• Reduced costs

• Improved intern/resident training

• Testing/verification of medical devices

• Anatomic models

• Surgical guides

• Virtual Surgical Planning

• Prosthetics

• Implants

• Therapeutic/adaptive devices

• Simulators

• Pharmaceuticals

• Bioprinting (tissues/organs)

• And further beyond

Current Applications

• The entry point for many point-of-care manufacturers (in-hospital programs)

• Used for surgical preparation, education, communication

• Currently no reimbursement plan exists

• No governing regulation

Anatomic Models, Surgical Guides/Rehearsal, and Virtual Surgical Planning

Prosthetics and Implants• First used for patient

specific cases

• Some 100+ 3D printed devices FDA cleared

• Initial investment is high, but there’s a reduction in overall resources and costs

• Growing adoption as more materials become available

Therapeutic/Adaptive/Corrective Devices

• Similar to prosthetics/implants, many orthotics are sold in standard sizes

• Adaptive devices can be 3D printed to help patients with special needs such as unique key guards, phone mounts for wheelchairs

• Patient-matched orthotics, casts, and braces producible using patient imaging

Simulation• Patient matched simulation to test

–Accuracy of 3D printed model

–Feasibility of implantable devices

–Pre-operative assessment vs post-operative results

• Unique opportunities to educate future clinicians of 1 in 1,000,000 types of cases

• Opportunities to replicate surgery on defects which are not in any textbook

• Bioprinting is an extension of traditional 3D printing, or rather, the production of complex living and non-living biological products from raw materials.

• Emerging need as number of patients waiting for transplants continues to rise.

• Applications: growing new tissues and organs, cancer research, drug screening, high-throughput assays, transplants, and regenerative medicine.

Bioprinting

Pharmaceuticals• 3D printing is a disruptive technology which

may require a new business model for pharma and regulations.

• Truly personalize dosages to specific patients• Changes the one-size-fits-all model• Powdered drugs bonded with liquid materials

= highly porous, rapid dissolving medicine• Batch, shape, surface area, and pill size

become customizable• Shifts production and distribution closer to

consumers

Process Overview

Process Overview

Detailed Process

• Personnel: physician champions, engineer(s), administration

• Equipment

• Ordering Mechanism

• Space

• Quality Assurance Process

• A Defined Vision and Mission

• Short and Long Term Goals

• Reimbursement Plan

• Method of Measuring Impact

Implementation

• Organizations– SME Medical AM3DP Workgroup– RSNA 3D Printing Special Interest Group (SIG)

• Upcoming Conferences– RAPID + TCT MMI 2018 (April 23-26)– The Materialise Experience Transforming 3D Printing (June 7-8)

• Literature– Regulatory Considerations in the Design and Manufacturing of Implantable

3D-Printed Medical Devices– Medical 3D Printing for the Radiologist – Technical Considerations for Additive Manufactured Devices Draft

Guidance for Industry and Food and Drug Administration Staff

Helpful Resources

Summary

• 3D printing in healthcare is experiencing a slow but growing adoption.

• Barriers to entry: lack of regulation, initial overhead, lack of reimbursement, personnel

• Applications are numerous and will continue to expand as technologies evolve and materials become available.

• The potential benefits to physicians, patients, and innovations to existing products outweigh the investment.

1. 3D Printing Fuels the Rise of Point-of-Care Manufacturing. (n.d.). Retrieved March 28, 2018, from http://sme.org/POC/

2. Feinberg, A. (2013, April 01). How 3D Printing Gave This Man His Life (and Face) Back. Retrieved March 28, 2018, from https://gizmodo.com/5993147/how-3d-printing-gave-this-man-his-life-and-face-back

3. Stryker Receives FDA Clearance for 3D Printed Tritanium® PL Posterior Lumbar Cage. (n.d.). Retrieved March 28, 2018, from https://additivemanufacturingtoday.com/stryker-receives-fda-clearance-for-3d-printed-tritanium-pl-posterior-lumbar-cage

4. Hobson, B. (2017, April 21). Movie: 3D-printed medical implants by Sebastiaan Deviaene. Retrieved March 28, 2018, from https://www.dezeen.com/2015/10/08/movie-sebastiaan-deviaene-design-medical-implants-3d-printed-video-game-software/

5. Morrison, R. J., Kashlan, K. N., Flanangan, C. L., Wright, J. K., Green, G. E., Hollister, S. J., & Weatherwax, K. J. (2015, August 03). Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices. Retrieved March 28, 2018, from https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12315

6. Grunewald, S. J. (2016, March 28). Italian Hospital Begins Using 3D Printed Prosthetic Bone Implants on Cancer Patients. Retrieved March 28, 2018, from https://3dprint.com/126314/3d-print-bone-implants-italy/

7. Traczyk, M. (2017, February 28). The Making of a 3D Printed Rehabilitation Orthosis. Retrieved March 28, 2018, from http://blog.zmorph3d.com/3d-printed-rehabilitation-orthosis/

8. Parvez, S. (2015, December 11). Andiamo – 3D printed orthotics for disabled kids. Retrieved March 28, 2018, from http://equalitytime.co.uk/5342/2015/08/12/andiamo-3d-printed-orthotics-for-disabled-kids/

9. O'Neal, B. B. (2017, August 14). Protosthetics and c2renew Partner to Create 3D Printing Filament for Definitive Prosthetic Sockets. Retrieved March 28, 2018, from https://3dprint.com/184030/protosthetics-c2renew-partner/

10.Mendoza, H. R. (2014, August 11). 3D Printed Bolus Protects Cancer Patients During Radiation Therapy, May Cut Treatment Costs Substantially. Retrieved March 28, 2018, from https://3dprint.com/10030/3d-print-cancer-treatment/

11. T. (2015, November 10). 3D printed simulator models by Fractured FX allow surgeons to practice operations for sick kids. Retrieved March 28, 2018, from https://www.3ders.org/articles/20151110-3d-printed-simulator-models-fractured-fx-surgeons-to-practice-operations.html

12.Alwais, S. (2017, December 14). 3D Printed Vascular Simulation Models Improve Training. Retrieved March 28, 2018, from http://blog.stratasys.com/2016/06/28/3d-printed-vascular-simulation/

13. Pew, S. (2016, November 10). 3D Printing in Clinical Simulation for Improved Education and Training. Retrieved March 28, 2018, from http://www.javelin-tech.com/3d-printer/3d-printing-medical-education/

14. Scott, C. (2016, January 24). Materialise 3D Software Leads to Successful Jaw Replacement Surgery. Retrieved March 28, 2018, from https://3dprint.com/115794/materialise-surgical-software/

15.How it Works? (n.d.). Retrieved March 28, 2018, from https://3dbioprinting.weebly.com/how-it-works.html

16.Mitsouras, D., Liacouras, P., Imanzadeh, A., Giannopoulos, A. A., Cai, T., Kumamaru, K. K., ... & Ho, V. B. (2015). Medical 3D printing for the radiologist. Radiographics, 35(7), 1965-1988.

References

Artificial Intelligence and Digitizing of the Supply Chain

iO Innovation OchsnerPresenters:

Michael Louviere, PD, MS, MBA

System VP Supply Chain

Ochsner Health System

Making the Highest Quality

Health Care Affordable

OMC West Tower Expansion

Covington Clinic Expansion

Benson Cancer Center Expansion

Baton Rouge Cancer Center

Outpatient Diagnostic Imaging CenterOchsner Select Rehab Hospital

• According to a recent study by Accenture, healthcare’s artificial

intelligence market will reach $6.6 billion by 2021.

• AI is able to process and analyze enormous amounts of

patient data, provide guidance and decision support,

and improve clinical workflow.

• Though no one expects AI to replace physicians, one recent study

found that the majority of healthcare executives believe that artificial

intelligence advances will result in a reassessment of most aspects

of their business in the near future.

Ochsner Health System recently launched a new artificial intelligence

technology that provides early warning alerts for patients that

experience critical health events (especially patients not in the ICU).

The goal of this predictive analytics platform, is to

minimize the severity and frequency of adverse events and

improve patient safety.

These platforms promise an added benefit of being relatively

inexpensive to implement, while potentially reducing incidents, thus

lowering care costs.

We need to start with Population Health• Has been defined as the health outcomes of a group of individuals,

including the distribution of such outcomes with the group.

• Aims to improve the health of an entire human population. • Aims to reduce health inequities or disparities among different population

groups due to, among other factors, the Social Determinant Of Health. • The World Health Organization reported in 2008 that SDOH factors were

responsible for the bulk of diseases and injuries and these were the major causes of health inequities in all countries. (Social, economical, environmental, cultural & physical)

• In the US, SDOH were estimated to account for 70% 0f avoidable mortality.

Next step is review Clinical Care PathwaysOchsner’s ONE Path: Definition

A multi-disciplinary approach to inpatient care that standardizesthe sequence and timing of care given to a specific group of patients during a well-defined period of time.

• Frequency of Hospital Emergency Codes ?• Frequency of Emergency Episodes at Work, at Home?

• What if you can prevent them?• What is that worth, in patient satisfaction, in cost, in

reduced readmissions….?

• Ochsner Pilot Project wins Innovation Award• Apply Machine Learning directly at the

Patient Bed Side using real time data with Predictive Analytics that can save lives.

• Collaboration between Ochsner, EPIC and Microsoft