The Power of Plastics in Healthcare - Aran RD...The Power of Plastics in Healthcare Aran Seminar April 2017 Christoph Koslowski Senior Sales Development Manager, Healthcare Thank you

The Power of Plastics

in Healthcare Aran Seminar

April 2017

Christoph Koslowski Senior Sales Development Manager, Healthcare

Vorführender

Präsentationsnotizen

Thank you to the chairs for that nice introduction and Thank you for attending our presentation. Today I’m going to share the Power of Plastics in Healthcare. My hope is to inspire you to consider plastics as a critical partner in Healthcare Innovations. So to do that we start with understanding what can plastics do.

RFID non-interference

Color coding

Transparency

Radio-opaque or -lucent

Branding ability

Reduce costs

Ergonomical

Reduce weight

Biologically safe Design freedom

Anti-microbial

Stress shielding solution

Imaging friendly

Single-use

Resistant to aggressive chemicals

Bioresorbable

What can plastics do for Healthcare

© 2014 Solvay Specialty Polymers 2

Vorführender


Well If you ask a group of people to think of words or phrases that describes what a plastic can do you’ll get many different answers. Here is a short list to consider. None is more important than another and all of them can apply to Healthcare. Just to point out some of the more common ones, plastics can bring weight reduction, can be radio-opaque or provide color coding. Now let’s take a look at how some of these properties have sparked the innovative process.

Specialty Polymers Industry Characteristics

• Top tier of plastics pyramid • High-tech material solutions • High barriers to entry • Driving and driven by innovation

• Market and application development • Large variety of markets • High added value • Global

Vorführender


The global polymers industry is comprised of a diverse array of polymers that offers a broad spectrum of performance. The specialty polymers version of the performance pyramid is unique it is three-sided to include elastomers & fluids. Specialty polymers are innovative, top-tier solutions. The overall production of these materials account for approximately 0.3 % of global polymer production volume.

Specialty Polymers Comprehensive Portfolio Aromatics, Fluoropolymers, Barrier Polymers, Performance Compounds

Key Performance Factors

Mechanical performance

Resistance to harsh elements

Broad range of temperatures

Surface properties Lightweighting Fire resistance

Vorführender


Within this specialized industry is a powerful array of the highest-performing materials, specifically developed to help design engineers solve the most challenging projects. Solvay is second-to-none in the industry, with the broadest portfolio of specialty polymers and the technical specialists who develop and support them. This is why Solvay is in the best position to help you find the right material for your innovative projects.


Turn a PROBLEM into an OPPORTUNITY

How can plastics drive innovation in Healthcare?

Vorführender


So how can plastics drive innovation in healthcare? The definition of the word innovation is introducing something new to solve a problem. This can be an existing problem or a future problem. In my group, we like to take away the negative word “problem” and replace it with the more inspiring word … opportunity. Here is where the innovation takes off. During the majority of this presentation I am going to share several real-life commercial examples of how plastics have done this in healthcare. But first, I’m going to take a quick moment to share why my company, Solvay, and myself standing here can speak with authority on this subject.


Solvay Group

Solvay

Planck

Rutherford

Curie

Einstein

Solvay Physics Council, Brussels 1911

Founded in 1863: 150 years of passion and tradition for science

Vorführender


Solvay founded in 1863 – 150 years old when we look into our family albums, we land on this picture that we like to share with customers because it speaks to our family heritage first Solvay Physics Council in 1911, funded and organized by Ernest Solvay – invitation-only event Brought together 18 luminaries of the time including Curie, Rutherford and Planck – notice Einstein who was 32 at the time Open innovation – partnering and collaborating with others to inspire each other to develop ideas that truly have the power to change the world History books report that not much happened at this gathering – because this was the first time these people had come together And this was at the start of the quantum revolution – the word photon would not be created for another 15 years, along with the challenge to determine whether it is a wave or a particle. the good news is that while this was the first, it was not the last – held every 3+ yeas – Oct 2013 will be the 23 conference Back row, left to right: Hans Goldschmidt; Max Planck; Heinrich Rubens; Arnold Sommerfeld; Cherwell Frederick Lindemann; Maurice De Broglie; Martin Knudsen; Friedrich Hasenhöhrl; Georges Hostelet; Édouard Herzen; Sir James Hopwood Jeans; Ernest Rutherford; Onnes Heike Kamerlingh; Albert Einstein; Paul Langevin. Front row, left to right: Walther Nernst; Marcel Brillouin; Ernest Solvay; Hendrik Antoon Lorentz; Emil Warburg; Jean Perrin; Wilhelm Wien; Marie Curie; Henri Poincaré.


Fifth Solvay Physics Council: October 1927

Einstein, after sparring with Niels Bohr and expressing disenchantment with Werner Heisenberg’s Uncertainty Principle :

“I am convinced that God does not throw dice.”

Bohr replied, "Einstein, stop telling God what to do".

Vorführender


halls of Solvay offices in Brussels are lined with photos from different years one of the most famous of these meetings was in 1927 – the 5th gathering Of the 27 attending, 19 had already or would go on to win a Nobel Prize On Youtube, there is a video from the 1927 Solvay Physics Council showing these men -- and one woman -- outside the building. What’s interesting is that during the day, they are laughing and talking, at the end of the day, they are shown leaving and they appear to be very angry. It is reported that there was much dissension as they argued their scientific theories, and Einstein himself writes about his irritation at the others. There is a famous reference in the history books that after sparring with Niels Bohr and expressing his disenchantment with Heisenberg’s Uncertainty Principle, Einstein proclaimed: I am convinced that God does not throw dice. To which Bohr is recorded as responding – Einstein, stop telling God what to do. One of the people seen in the Youtube video is a man name Auguste Piccard. He is also shown here in this photo. So who was Auguste Piccard? If you are a Star Trek, you may be interested to know that he was, in fact, the namesake for Captain Jean-Luc Picard


Pioneering Spirit

• Auguste Piccard: 1884-1962, first man to go 14 miles into the stratosphere in 1931 « The question now is not so much whether humans can go even further afield and populate other planets, but rather how to organize things so that life on Earth becomes more worthy of living. »

Auguste Piccard Jacques Piccard Bertrand Piccard

• Jacques Piccard: 1922-2008, first man in deepest point in the ocean in 1960 « The public has not yet woken up to the extent and seriousness of the problem of pollution. »

• Bertrand Piccard: 1998, first man to circle the Earth non-stop in a hot air balloon «

Adventure in the 21st Century consists of applying human creativity and the pioneering spirit to developing a quality of life which present and future generations have a right to expect. »

Vorführender


Auguste Piccard was the patriarch of three generations of pioneers and explorers. He was the first man to go 14 miles into the stratosphere in a balloon with a pressurized cabin. He was, in fact, the first person to see the curvature of the earth. One of his goals was to help prove a theory of his friend Albert Einstein – whom he likely met at the Solvay Physics Council Working with his son, Jacques Piccard, he then applied his knowledge about pressurized cabins to invent the first bathyscaphe, called Trieste, which Jacques and Dan Walsh used to be the first men to travel 7 miles below the surface of the ocean into the Mariana Trench in 1960. Building on that family legacy, Jacques’ son Bertrand went on to become the first man, in 1998, to circumnavigate the Earth in a hot air balloon. He took off with 3.7 tons of liquid propane, and landed in the Egyptian dessert with just 80 pounds of fuel on board. In his TED talk, Bertrand said he vowed, after landing safely in the Egyptian Desert, that he would never do that again. What he meant was that the next time he flew around the world, it would be with no fuel.


Solvay and Solar Impulse

• Solar Impulse is the first manned aircraft to fly around the world powered only by solar energy

• Solvay has been Main Partner since 2004

• On July 26, 2016, Solar Impulse landed safely after 43’041 kms in 17 flights that lasted a total duration of 558h 06min.

Two pilots flew around the world without fuel

Bertrand Piccard Andre Borschberg

Vorführender


In 2003, Bertrand Piccard began his vision to build a manned aircraft that could fly around the world fueled only by solar energy And who did he turn to help fund and organize this? His life-long family friends at Solvay In 2004, we became the only Sponsor for Solar Impulse. In 2010, other Main Sponsors were added – Omega, Deutsch Bank and Schindler (the elevator/escalator company) For several years, test flights have been occurring, and in 2014, they hope to fly around the world – with stops – which will take 20 days and more importantly in a plane fueled by energy from the sun – 20 nights. Note, it will take 5 days to cross the Pacific Ocean. For a pilot who cannot stand up. Who will these pilots be? Bertrand Piccard and his co-entrepreneur, Andre Borschberg


Halar® ECTFE Energy capture

Solstick

Energy capture

KetaSpire® PEEK PrimoSpire® SRP

Light weight / metal replacement

Solef® PVDF Energy storage Torlon® AI

Structure

Light weight / metal replacement

Ixef® PARA Radel® PPSU

Fomblin® PFPE Lubrication

TegraCoreTM PPSU Insulation Amodel® PPA

LEDs

OUR SPECIALTY POLYMERS ON BOARD


employees 27,000 140 industrial sites

21 major

R&I centers

58 countries

€ 10.9 billion of net

sales

€ 2,284 million of REBITDA

Solvay: A Major Player in Chemicals

• In Top 10 worldwide

• Global presence

• Diversified end-markets

• Sustainable development

• Operational excellence

Our strengths


Product Families

Advanced Lightweighting Solutions TegraLite™

• TegraCore™ PPSU Structural Foam

• Films • Composites • Virantage® PESU

Tougheners Biomaterials for Implantable Devices Solviva® Biomaterials

• Eviva® PSU • Veriva® PPSU • Zeniva® PEEK

Cross-linkable Compounds Cogegum® XLPO-HFFR Polidan® PEX/XLPE Polidiemme® XLPO

Films Ajedium™ Films

Fluorinated Elastomers Tecnoflon® FKM

• Base Resistant • Ionic Curable • Low Temperature • Peroxide Curable

Tecnoflon® PFR FFKM Fluorinated Fluids Fomblin® HC PFPE Fomblin® PFPE Lubricants Galden® PFPE Solvera® PFPE Fluoropolymers Algoflon® PTFE

• Dispersions • Fine Coagulated Powders • Granulars • Micronized Powders

Halar® ECTFE Hyflon® PFA & MFA®

Hyflon® AD Hylar® PVDF Hylar® 5000 PVDF for Architectural Coatings Polymist® PTFE Solef® PVDF

Functional Fluids Fluorolink® PFPE Fomblin® PFPE Functional Liquid Crystal Polymers Xydar® LCP Polyamide-imides Torlon® PAI Polyamides, Aromatic Amodel® PPA Ixef® PARA Kalix® HPPA Omnix® HPPA Polyesters, High-performance Lavanta® HPP Polyketones, Aromatic AvaSpire® PAEK KetaSpire® PEEK Polymer Processing Aids Solef® 11010 PVDF Tecnoflon® NM FKM

Polyphenylene, Sulfide Ryton® PPS Polyvinylidene Chloride Diofan® PVDC Ixan® PVDC Extrusion Resins Ixan® PVDC Soluble Powders Sulfone Polymers Acudel® modified PPSU Radel® PPSU Udel® PSU Veradel® PESU Specialty Materials Aquivion® PFSA Hyflon® AD Long Fiber Compounds Solvene® EAP Torlon® AI for Coatings


Color coding

Transparency

Radio-opacity

Branding ability

Reduce costs

Ergonomical

Reduce weight


Anti-microbial


Imaging friendly

Single-use


Bioresorbable

Driving Innovation Past …. Present …… Future


Vorführender


Now back to driving innovation. The examples I’m going to share are going to cover a broad spectrum of problems and solutions that will demonstrate a past, present and future view of plastic device innovations.


Opportunity: Improve Hemodialysis Patient Outcomes

• Saving the lives of kidney dialysis patients since 1995

• Better membranes than cellulose acetate

• More biocompatible • More chemically resistant

during cleaning and disinfecting • Better patient experience

Innovation: PSU (Polysulfone) for Hemodialysis Treatment

Past

Udel® PSU

Vorführender


As I said earlier, opportunities are chances to solve a problem. In this case we take a look at an opportunity to improve the outcome of hemodialysis patients Prior to 1995, cellulose acetate was the primary material used for the membranes in cartridges that filtered the blood for patients who had end stage renal failure. It was not uncommon that after having the dialysis process, a patient would feel sick even though the toxins had been successfully removed from his blood. These bad side effects affected not only the patient’s physical well-being but also their mental well being – causing patients to want to avoid the life-saving procedure all together. PSU – polysulfone – tradenamed UDEL was introduced to this market by Amoco (assets now owned by Solvay) due to its superior biocompatibility over the current material– its interaction with the blood was more compatible leaving the patients feeling better after their dialysis treatment with no bad affects. This innovation of using Udel PSU made the clinical dialysis process a viable treatment that people could safely do their entire life although it requires frequent and regular visits to the clinic. Of course hemodialysis innovations are still continuing today as companies are striving to make the process even less intrusive to a patient’s normal life with options that could bring the procedure into a patient’s home or even mobile.


Opportunity: Improve Efficiency for OR Teams

• Improved designs • More ergonomic • Lighter weight • Better organization • Transparent lids • Color coded

Innovation: PPSU (Polyphenylsulfone) for Cases & Trays

Past

Radel® PPSU

Vorführender


Another example of successful problem solving is the opportunity to improve the efficiency of operating room teams and hospital support staff by introducing a new innovative plastic to a very historically metal application. Pictured here are several examples of instrument carrying cases and trays used for surgical procedures. As you can see the number of instruments can be quite large and as many of you know, the number of instruments sets needed for complex orthopaedic surgeries could result in many, many cases. All of them are very heavy to move around. Since metal was the material of choice for the case, the case added even more weight In the mid -1990’s Radel Polyphenylsulfone was introduced (also by Amoco) as the first plastic that could perform like the metal in this application even in the aggressive chemical and high temp environment of steam sterilization. This improved design was much more ergonomic on the hands of the staff who carried them and clearly lighter weight. In addition as you can see from the thermoformed tray the organization of the instruments could also be improved for easier identification and counting. The plastic translucent lids allowed visibility to the instruments without opening because you could see through them. And by introducing color coding, sets could be identified without unstacking.


Opportunity: Improve Efficiency for Surgery

• Alternative to metal • Lighter weight reduces fatigue • Ergonomic for surgeon’s hands • Color coded to decrease

chance of error • Quick visual identification

Innovation: PPSU (Polyphenylsulfone) for Medical Devices & Instruments

Past

Radel® PPSU

Vorführender


Similar to the case and tray solution, there was also an opportunity to improve the efficiency of the surgeon as well. Also using Radel PPSU, the introduction of plastic devices and partially plastic instruments was a real alternative to the often heavy metal instruments that you saw in the previous slide. Device engineers were able to easily propose more ergonomic designs because the Radel PPSU is easy to machine or mold in smooth rolling shapes. This was helpful in the surgeon’s hands to reduce fatigue and increase accuracy. The bright colors which were made using biocompatible pigments decreased the occurrence of errors during the surgery by providing quick visual identification and confirmation that he had the right instrument or device.

Macro Trends

• Aging population

• Increase in treatable diagnoses

• Growing global middle class

• Health of our economies

• Government oversight

• Cost control

Macro forces affecting Healthcare

Present … Future


Vorführender


So now I’ll change to more current examples. First, I will quickly tie in some broad industry trends that are helping to uncover some of the challenging problems that our industry is currently trying to address. On this slide is a list of some global trends. Some of these trends have more influence in some regions than others. I will highlight 3 areas which are drivers for plastics to bring an innovative solution. These are the aging population in coordination with the growing middle class and then also the desire to control costs. I’ll go into more detail on the next slides


Opportunity: Improve Quality of Longer Life

• Alternative to metal • Biocompatible • Radio-lucent • No halo effect during imaging • Modulus similar to cortical bone

Innovation: PEEK (Polyetheretherketone) for Orthopaedic Implants

Present

Zeniva® PEEK

Vorführender


The first 2 trends are driving what the typical orthopaedic patient is now looking for. As we grow older and stay active and as the number of people in the middle class expands and have more access to affordable quality healthcare, a joint replacement or spinal repair patient is looking for their quality of life to be high and to last for a longer amount of time. The current activity in the industry is that we are in the process of accepting a new innovative material as a solution to meet the expectiations for long-term implant efficacy. Polyetheretherketone, PEEK, in these cases shown here Zeniva PEEK, is a viable alternative to metal giving several advantages. One is that it is radio-lucent (can be invisible during x-ray) so the surgeon has more visibility to the healing process during post-surgery reviews. Another key advantage is that imaging does not have the shadowy halo effect when plastic is used that you commonly get when a metal implant is used. And most importantly is that the modulus of Zeniva PEEK is similar to cortical bone which minimizes occurences of bone resorption as a function of stress shielding. All of these advantages support a decreased likelihood of the chance of a revision during a patients lifetime.


Opportunity: Reduce Hospital Acquired Infection Rates

Innovation: PARA (Polyarylamide) for Single-Use Instruments

Present

Ixef® PARA

Vorführender


The other driver is cost reduction which is fueled primarily by government and regulatory oversight. An example from the US is that reimbursement eligibility to a hospital is becoming tied directly to patient outcomes. If a patient acquires an illness as a result of exposure to a virus during their stay in the facility, reimbursement can be denied for the treatment of that infection. To control this cost, hospitals have begun tracking where these exposures occur and looking for innovative solutions to keep it from happening. One source identified is surgical site infections (SSI). This is where a microbe can be introduced to the surgical incision site via an instrument that has been understerilized during central services sterilization or through unintentional exposure during the handling of the instrument after sterilization. Ixef polyarylamide brings this solution. The unique strength and stiffness properties of this material enables plastic designs for critical instruments that many designers never dreamed could be done in plastic. Some examples shown here are general instrument conversions of forceps and hemostats and if any of you had the chance to hear the case study presentation given yesterday by Will Qiang (also from Solvay) you will recognize the remarkable conceptual redesign of the Hohlmann retractor used for hip replacement. These color-stable materials can be gamma sterilized and then packaged for delivery to the surgery - untouched and verified sterile. After use, the instrument is disposed and cross-contamination possibilities are eliminated.


Added Value: Opportunity to Reduce Costs Innovation: PARA (Polyarylamide) for Single-Use Instruments

Reusable Single Use

Sterilization

Packaging

Delivery

Control

Storage

Surgery Ixef® PARA

Vorführender


But there is also a bonus added value to the Ixef PARA solution. There is also the opportunity to reduce costs. In some cases, using Ixef PARA to replace expensive metals like titanium can achieve cost reduction through design and material cost only. In other cases the cost savings can come from the substitution of the reusable instrument sterilization cycle versus the single use path costs. There are some current life cycle analysis studies underway to confirm that the savings, in certain supply chain scenarios, can be achieved.

• A high-performance, specially-formulated polymer

Introducing Ultaire™ AKP

Near net shape disk CNC

machining

Final part

Solvay Dental 360™ Present


Color coding

Transparency

Radio-opacity

Branding ability

Reduce costs

Ergonomical

Reduce weight


Anti-microbial


Imaging friendly

Single-use


Bioresorbable

Driving Innovation Past …. Present ……

What’s Next?

…… Future


Vorführender


So far we’ve discussed the past and the present innovations …. What innovations can plastics bring next? My final 2 examples will talk about some very exciting plastic technologies developed directly for the next generations in healthcare innovation.

Opportunity: Improve Osseo-integration of PEEK

• Created in partnership with Georgia Institute of Technology and MedShape

• Provides interconnected, surface porous network

• Promotes bone ingrowth through multiple porous layers

Innovation: Partner with renowned University to create Surface Porous PEEK

Future


Vorführender


While PEEK is well known for its mechanical strength and biocompatibility, it is also well known that it is SO inert that it discourages bony ingrowth in orthopedic related devices. Over the years, technologies such as coatings and fillers have been proposed to improve the osseointegrative properties of PEEK. Some of these have fairly good results while others simply lack any real clinical data to show they are effective. This year, MedShape, a small US-based orthopedic company, launched a Zeniva PEEK suture anchor that included surface porosity. Animal studies on this technology indicate significant bone mineralization within the pore network. Additional animal studies are ongoing to provide further evidence of the osseointegrative abilities of this technology. Based on the extremely positive response to MedShape’s launch earlier this year, this appears to be one of the most exciting technologies to hit the orthopedics market in years. The development of this porous surface technology was funded by Solvay in partnership with MedShape and the Georgia Institute of Technology in Atlanta GA. And we’re very excited to be a part of this possibly revolutionary innovation.

© 2014 Solvay Specialty Polymers` 24

Opportunity: Flexible PEEK structures

• Custom designed structures • Validated value chain includes

full product traceability • Mechanical Property of fibers

similar to PET fiber • Robust biological safety for

Zeniva PEEK

Innovation: Partner with Secant Medical to offer Zeniva PEEK fabrics and fibers to the implantable devices market`

Future

Vorführender


And finally…Over the years, PEEK has primarily been used as a rigid, structural material. But with the rise in Minimally Invasive Surgeries, or MIS, our customers have been asking if there are options for deployment of a PEEK structure during MIS. This led to a partnership with the company Secant Medical to provide Zeniva PEEK fabrics and fibers for the implantable devices market. These fabrics may be customized for each application, such as hernia repair mesh or something more load bearing. Additionally, Zeniva PEEK fibers may be considered as an option for sutures. The device designer gets the benefits of Secants experience in biomedical textiles while also leveraging the robust dossier of biological safety information for Zeniva PEEK.

3D Printing

• Many different techniques exist: SLS, FDM, FFF.…

Selective Laser Sintering (SLS) Fused Filament Fabrication (FFF)

Future

The Power of Plastics in Healthcare

Biocompatible formulations

Provide practitioner comfort

Facilitate creative designs

Control Spread of Infection

Improve patient outcomes

Support new ways of doing things

Improve visual aesthetics

Make old techniques better

Differentiate your company

…… many, many things


Vorführender


Just to recap …….. Some examples of the power of plastics in healthcare Biocompatible formulations / facilitiate creative designs / provide practitioner comfort / control spread of infection / improve patient outcomes / support new ways of doing things / make old techniques better / improve visual aesthetics / differentiate your company …. Many many things

Coming to Grips with Specifying High Performance Plastics

A Metal Retractor Case Study

Version 1.2

Christoph Koslowski, Solvay Europe

Thanks to our collaborators …

… we value our parters.

Greg Hall, International Business Development

Rob Rice, Development/Design Engineering

Mike Ulanowicz, Sr. Technical Sales Manager

Mike Kell, Sr. Marketing Manager

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Seven Steps from Metal to Plastic

1. Definition of Requirements 2. Conceptual Design 3. Material Selection 4. Engineering Design and Mechanical Simulation 5. DFM/ Process Simulation 6. Prototyping 7. Validation Testing

An alternative retractor’s journey …

30

1. Design Requirements • Function • Mechanical Performance • Thermal Performance • Chemical Compatibility • Usage Scenario • Economical Considerations • Regulatory Aspects

→ Qualifiers versus Differentiators

≈ “Need to have, want to have” ≈ “Constraints vs Objectives” ≈ “CTQ’s”, Kano model categories

Voice of Experience: Explicit, Thorough, Detailed

31

Requirements – Build a Checklist …

A best practice: An actual written checklist as a guide

32

Document Your Findings …

Drill Down: Record/Categorize/Quantify/Clarify

Check List

# Requirement(double click topics to expand / collapse)

CommentsStatus

(double click to change)

1 Function 1.1 What is the function of the part? 1.2 What is the expected lifetime of the part? 1.3 What agency approvals are required? (ISO, UL, FDA, USDA, , USP,

MIL spec)

1.4 Will the part be implanted in humans? If so, biocompatibility is your first concern.

1.5 Will the part be used in an optical system?

2 Environment 2.1 What temperature will the part see? And, for how long? 2.2 What chemicals will the part be exposed to? 2.3 Is moisture resistance necessary? 2.4 Does the part need to be sterilized? With what methods (chemical,

steam, radiation)?

2.5 Is weathering or UV exposure a factor?

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2. Conceptual Designs • Differentiation or Imitation? • New functionality? • “Soft Attributes” – look, feel, sound • What if …? Could we …? The customer wants …

Best Practices: Outside Input - “Think big” Wish Lists - Use Variants

34

2. Conceptual Designs

“Designing with Plastics isn’t harder, it’s just different.”

Be sure your designers consider the freedom plastics have to offer.

35

3. Material Selection - ABC

Actual Performance Requirements

Match property requirements with potential plastic material candidates. - Materials Databases - Supplier Documentation - Conversion Partners - Outside Specialists - Predicate Devices

36


Actual Key Retractor Requirements = Stiffness and Strength

Material Tensile

Strength MPa

Young’s Modulus

GPa

Specific Gravity

Titanium 345 100 4.5

Steel 330 200 7.8

Aluminum 320 70 2.8

Magnesium 225 40 1.8

PARA Ixef® 1022 280 24 1.7

PAEK AvaSpire® AV-651 GF30 162 10 1.5

PEEK KetaSpire® KT-880 GF30 190 11 1.5

PEEK KetaSpire® KT-880 100 3.8 1.3

PPSU Radel® R-5000 70 2.3 1.3

37

Biocompatibility Categories per ISO 10993-1


Retractor = Limited exposure, Tissue/Bone/Blood contact.

38

Biological risk must be addressed by the device manufacturer. Raw materials chosen are often where evaluation begins.


Biological Safety - Some Supplier Questions:

• Any Policies which support certain healthcare applications, while excluding others?

• Are specific “medical grade” materials offered?

• Is there a long term commitment to the industry?

• How is formulation change handled?

• Available technical, regulatory, processing, design support?


Does your material supplier ”have your back?”

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Single Use Devices • Sterilized once • Cleaning & disinfecting

not required • As-molded properties*

Reusable Devices • Sterilized repeatedly • Cleaned & disinfected

repeatedly • Long-term properties

(3+ years)

Designed for a single procedure.

Engineered to Deliver Long-Life Performance


Life Cycle determines required properties of interest …

*assumes validated sterilization stability

41


Compare properties based on targeted Life Cycle …

42

4. Engineering Design / Mechanical Simulation

FEA simulation: Begins with “can we get there?”

0.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

40.0

45.0

50.0

0.00 0.10 0.20 0.30 0.40 0.50 0.60

Deflection (in)

Forc

e (lb

)

Deflection, Real (in)Deflection, FEA, 29,000ksi Modulus (in)Deflection, FEA, 18,000ksi Modulus (in)Deflection, Ixef 1022 (in)

Vorführender


Main function, bending load, equivalent stiffness … model metal Step 1: mimic simulation Link – reality to computer - baseline most basic plastic design modification = ribbing

43

Iterates through conceptual designs to mechanical models

Design Restriction = Tip Geometry

4. Engineering Design / Mechanical Simulation

44

5. Process and Manufacturing Simulation

• Greatest design change flexibility

• Greatest cost efficiency for smaller quantities

• No parting lines, ejector marks, or flash

• No draft angles required

• Closest tolerances possible

• Lowest component stress

• Fastest turnaround time

• Low or no tooling cost

• Ease of producing features such as threads and undercuts

• Up to 25x lower per part cost

• Part consistency

• Potential to simplify supply chain

• Economy of scale leverage for larger quantities

0 5000 – 10000* 50000+

Parts per year

* Traditional “rule of thumb.”

Machining

or

Molding?

45


• Difficult part design for machining, 7 operations estimated to complete.

• No existing stock shape channel for resins selected

• Resins chosen forfeit 40% of their properties in machined form.

• Estimated cost (100 parts) = $145 / part

• Estmated cost (10,000 parts) = $125 / part

• Single tool with insert cavity for multiple handle geometries is possible.

• Up front tooling cost = $38,000

• Estimated cost (100 parts) = $49.00 / part

• Estimated cost (10,000 parts) = $7.50 / part

Chosen: Injection molding with an insert for the handle.

46


Machining is here to stay!

Trends within Orthopedics – Molding/Machining • Molding Strategies Reduce Annual Volumes

• Inserts • Family tools • Common Halves

• Hybrids – designs using both plastics and

metal, often inserts

• Integration of Molding and Machining • Near net shapes • Suppliers moving to offer both processes in

house

• Mold “Center of Bell Curve” Size

Ann

ual Q

uant

ity

47


Oversimplified: 200+ SKU’s not = 200+ tools …

Recent Case Study on 200+ SKUs of Metal predicate part

• Major orthopedic OEM, reusable device • Predicate metal part $98- each • Molded part cost $23- each • Tooling cost $2MM –> a true commitment to the progam • Demand = 200 parts/year of each SKU

• Predicate metal = $3,920,000/year • Plastic = $920,000/year • Tooling more than paid for itself in the first year

• In addition to cost savings, the OEM gained capacity of 2 full CNC machines for implant manufacture

48


Experienced support can be particularly valuable here …

Considerations specific to plastics and injection molding:

• Gating • Anisotropic (non-uniform) properties, fiber orientation • Knitlines or Weld Lines • Shrinkage/warpage

Many can now be simulated in advance …

49

The simulation favored the handle as injection point …

Injection Molding Simulation

50

Prediction of Knit Lines

Handle injection point yields better weld/meld path for flow fronts of molten plastic to rejoin …

The choice of a slotted handle design necessitated a knit line.

Vorführender


End gate provides uniform fiber orientation down the entire length of the part. Center gate forms unoriented patch in the center and also at the end of fill from the knit line not fully melding.

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6. Prototyping

Multiple options for prototypes exist :

• Additive Manufacturing* • Stereolithography (SLA) • 3D-Printing • Fused Deposition Modeling (FDM) • Laser Sintering (SLS)

• “Soft” injection molding tool • Pre-production steel tool with cores • Machined samples from stock shapes

*Actively being explored for Orthopedic Short Run Production

Retractor Handle Concepts via SLS

(Paragon)

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7. Validation Testing

Actual comparative measurements versus incumbent.

Repeat characterization tests using newly produced plastic parts.

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7. Validation Testing … to be continued …

Next step … some actual end user feedback.

Conclusion/Takeaways

• Feasibility of an all plastic retractor can be demonstrated. Next step = desirability.

• Robust capabilities are developing within Orthopedic supply chains to further enable metal replacement. The industry is maturing.

• Regulatory aspects are becoming increasing important, and should be included early in the design stage.

• Healthcare OEM’s have experienced resources to call on to guide them through the metal replacement process.

Wheel reinvention not required ….

Thanks for your attention!

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The Power of Plastics in Healthcare - Aran RD...The Power of Plastics in Healthcare Aran Seminar April 2017 Christoph Koslowski Senior Sales Development Manager, Healthcare Thank you