3-D PRINTED TITANIUM IMPLANTS THAT PARTICIPATE IN THE HEALING PROCESS

Porous surfaces

In orthopedic implants it is common to create porous surfaces designed to promote ‘osseointegration’ – where a patient’s bone is encouraged to fuse with the metal implant to secure it firmly in place.  The implant’s surface is covered with a carefully designed layer of lattice, which has the optimum spacing and strut thickness to enable living bone to grow into it and form a strong, load-bearing bond with the metal device.

Image above – SEM image of the porous surface of an acetabular cup. 

So lattices have a number of attractive qualities, although their complexity and delicacy can make them challenging both to design and to manufacture.

Lattice design

Most lattice materials are made up of arrays of slender members that resemble familiar lightweight super-structures such as bridges and building frames, but obviously on a much smaller scale.  These complex meso-structures can be produced additively in length scales that vary from microns to millimetres. 

Image above – Cubic lattices with various length scales.  The minimum producible scale is limited by the smallest strut thickness that can be manufactured on an additive machine, which can be as little as 140 microns on a laser powder-bed fusion machine with a 70 micron laser spot size. 

Lattice structures can be regular (such as the cubic lattices shown above) or irregular, and designed to provide either homogeneous or heterogeneous properties. The length scale can vary throughout the lattice volume to tailor its properties – particularly its density and stiffness – in different locations.

Image above – Sectioned femur in which the internal trabeculae form an elegant three-dimensional latticework that mimics the structures seen in natural bones.  The length scale and strut thickness vary throughout the lattice volume.  

Lattice types

The choice of lattice geometry is critical to effective light-weighting, enabling porous materials that approach the strength of their solid counterparts, yet at far lower densities.  Some porous structures such as foams are light, but not all that strong.  Their structures are said to be ‘bending-dominated’, so that loads applied to the macro-structure are resisted by bending of the struts in the meso-structure.  This makes them compliant and good for energy absorption. 

By contrast, lattices that are ‘stretch-dominated’ carry their loads axially along the struts, either in tension or compression.  Such structures are characterized by high levels of node connectivity, providing cross-bracing to prevent relative motion of the nodes.  These ‘space frame’ meso-structures, like their large-scale architectural equivalents, provide the best strength-to-weight ratio.

Image above – The bending-dominated structure (on the left) is much weaker than the stretch-dominated structure (on the right).

Gyroids 

Not all lattice materials comprise simple strut-and-node arrangements.  Gyroids are triply periodic structures, built up of small cells of curved ‘minimal’ surfaces that repeat in all directions to form a regular structure.  In certain circumstances, these structures can have higher specific strengths than regular diamond lattices.  Image from Wikipedia.

 

Image above – gyroid lattice structures.

Architectured materials

Thanks to the flexibility of additive manufacturing, we can now design and build ‘architectured materials’ in which the meso-structure has been tailored to provide specific mechanical properties.

Image above – Architectured material with heterogeneous properties.  Its fibrous structure exhibits, like a composite, different stiffness in different directions.  

Hybrid lattice structures

As we have seen above, lattices can be integrated neatly into product designs.  They can also be combined with other weight-saving techniques such as topological optimization.  The super-structure of the part can be shaped using generative design, with further weight-saving gains achieved by applying a lattice meso-structure onto some of the super-structure.

Image above – An architectural ‘spider’ bracket from titanium combines topological optimization with lattice materials to minimize component mass.  ww.youtube.com/watch?v=WMCR6VBSV-E

Image above – cross-section of the spider bracket showing the combination of solid and lattice structures.

Lattice build preparation

A key computational challenge for the additive manufacturing of lattices is how these complex structures are represented and converted into a build file.  Most additive components are designed in 3D CAD and then converted into a triangulated surface format (STL).  These STL models are then sliced into thin layers from which we compute the laser paths needed to build up the part.

If we take this approach with lattices, especially those with a small length scale, then we quickly run into enormous models and interminable build file preparation.  Specialists in lattice design and additive manufacture are looking at ways to simplify the generation and manufacture of such complex geometries through novel representations and custom laser exposure strategies. 

Image above – Fine struts in additively manufactured lattices are best built with custom exposure strategies for better mechanical performance and faster build times. 

Lattice manufacturing

Manufacturing of fine details requires precise control of the laser energy, as the melting on each layer of the lattice build often comprises thousands of sparsely distributed exposures.  There currently is at least one system that features a modulated laser focused down to 70 microns spot size, enabling production of struts and walls as thin as 140 microns.

Image above – A volume of 8,000 cubic cm of architectured material made from Ti6Al4V.  

Future challenges

For all their attractions, there remain some barriers to deploying lattices in production parts.  A key challenge is to substantiate the suitability of the design for stressed applications, particularly where fatigue is the critical performance attribute.  By necessity, lattices contain lots of ‘as built’ surfaces and sharp intersections, which create stress raisers.  To balance this out, lattices have a lot of built-in redundancy, and so may not fail catastrophically.

These characteristics make structural parts with load-bearing lattices best suited to applications where the loads are either constant or single, dynamic events.  Cyclical load bearing applications look likely to be a little further off.

A related concern is how to validate lattice quality in manufacturing.  The complexity and inaccessibility of lattice features makes them hard to inspect.  CT scanning offers a solution, albeit a somewhat time-consuming one.  The best answer here is likely to be in-process monitoring, so that we can demonstrate that each element of the lattice material has been built correctly.

Summary

Complex lattice structures can deliver exceptional product performance – both in efficiency and functional terms.  They are key tools in component light-weighting, and can also boost heat transfer, energy absorption, insulation and joining performance.  Careful lattice design can introduce precisely tailored properties into efficient components.

Additive manufacturing is often the only practical way to produce such intricate materials.  A great amount of detail needs to be invested in investigating the latest software tools and selection of an AM machine that is optimized for fine detail work.

What Is Product Development?

Across the medical device industry, the role of a product manager has far-reaching responsibilities within a given organization. Accountability from a product’s conceptualization through the end of its life cycle presents challenges that require a proactive approach to risk and life cycle management. 

Product development is the art and science of understanding what to build and why to build it.  Part marketer, part engineer, part sales, and part project manager, the product manager must lead engineering, surgeon consultant, regulatory, compliance, finance, and marketing teams from concept through commercialization; navigating patent, FDA and International regulatory compliance, market access, and reimbursement landscapes. 

Product managers are responsible for surpassing financial contribution targets through strategic product differentiation and satisfaction of unmet user and clinical needs by increasing procedural efficiency and improving patient outcomes.  

Proactive communication is a trait of successful product managers in order to clearly define expectations and create organizational alignment to deliver projects within a designated budget and timeline while ensuring conformity to regulatory, compliance, and company policy / procedure requirements.

Did I mention communication?  Here’s a great example demonstrating why communication is vital to successful development of any product.

 

Product Management Quotes From A Few Well-Know Leaders

“If you are not embarrassed by the first version of your product, you’ve launched too late.”
– Reid Hoffman, LinkedIn

“Make every detail perfect and limit the number details to perfect.”
– Jack Dorsey, Square

“If you continue to improve a product enough, you’ll eventually ruin it.”
– David Pogue, the New York Times

KEY POINT: It’s better to go to market today with an 80% solution, than wait for a 100% solution tomorrow.

PERFECT
is the enemy of
GOOD

 

What is project MANAGEMENT?

Many organizations still struggle to answer this question. While the roles of the project and product manager vary from company to company, there are some unique characteristics that characterize the two.

A lot of project managers look up to program managers and aspire to be in their shoes one day. In order to be able to get to that level, project managers, as well as their organizations, must clearly understand the general responsibilities that are expected from each role. Organizations can then communicate them to their employees, allowing them to train themselves and set goals accordingly.

 
What is Project Management?

By definition, project management is the application of knowledge, skills, tools and techniques to project activities, to meet project requirements.

The job focus of the project manager is both narrower and deeper than that of the program manager. Project managers are responsible for the project, the project team, and the outcomes the team is working on.

What is a project?

Projects include:

  • A sequence of tasks
  • Defined outcomes, and deliverables
  • Defined beginning, end, schedule, and approach
  • Planned budgets
  • Resources specifically allocated to the work
  • Organized approach
 
What is Program Management?

The Project Management Institute (PMI) defines program management as:

“A group of related projects managed in a coordinated way to obtain benefits and control not available from managing them individually. Programs may include elements of related work outside scope of the discrete projects in the program.” – PMBOK pg 368

 
What is a program?

According to Wiki Answers, “ a program is something which delivers a massive piece of functionality. Within this program will be a large number of individual projects each of which will deliver a specific piece of the functionality. When all these projects have delivered, all their pieces will make the big deliverable.”

Programs include:

  • A single product or deliverable
  • Many product deliverables
  • Usually focuses on business objectives and delivering value
  • Benefit management
 
Project management vs Program management

Project managers:

  • Focus on content
  • Manage projects
  • Focus on scope, schedules, resources
  • Perform more technical tasks
  • Handle risk management
  • Deal with project requirements
  • Are responsible for ensuring projects get completed on time, within budget


Program managers:

  •  Focus on context
  • Manage portfolios
  • Focus on people, politics and negotiating
  • Perform more strategic tasks
  • Handle change management (program and environmental changes)
  • Deal with business strategies and objectives
  • Are responsible for maximizing ROI and value delivery

 

Even though there are many similarities between the project manager and program manager roles, being able to tell what sets them apart can help companies be more productive and deliver better results.