For design engineers, 3D printing (3DP) and its ability to be used as additive manufacturing (AM) is opening design and employment opportunities in the medical care industry. 3DP/AM is behind the rise of Point-of-Care (POC) manufacturing. POC refers to the just-in-time creation of medical aids like surgical models, instruments, prosthetics, and other 3D printable items that improve the ability of physicians to deliver better and lower cost patient care.

SME recently released a study, Physicians as manufacturers: the rise of Point-of-care manufacturing, on the use of AM in the medical field, with an emphasis on POC. According to the study, non-profit and for-profit hospitals, university engineering departments working with hospitals, government hospitals and contract manufacturers with hospitals as clients are all adding POC additive manufacturing on-site.

According to the study, 69% have used 3D printing for three years or more; and 99 U.S. hospitals have a centralized 3D printing facility.

The SME study notes that the most popular applications for AM/3DP are the creation of anatomical models (71%), for use in prototyping, design and development (56%), and the creation of tooling jigs and fixtures (46%).

About 43% of the applications are for the development of surgical instruments. The dental industry has received a lot of attention lately with new machines recently introduced by additive vendors. About 28% of the medical users studied in the SME report were in dental applications. And, despite some of the hype surrounding bioprinting, only 6% of these businesses were exploring the use of 3DP.

The most common additive technologies used are extrusion and vat photopolymerization.

For the medical community, the benefits of having additive equipment on premise include:

–lower operating room times and readmission rates, which saves costs for the institution.

–the ability of clinicians and engineers to work more closely together, delivering regular iterative feedback.

–growth in innovation, which can help develop non-traditional revenue streams.

But along with the benefits, there are improvements that could increase the use of AM in patient care.

–3D printing and processes need to become more plug-and-play.

–Hospital administrators are realizing that they need a suite of products (software, hardware, materials) for usage to grow.

–Other challenges include financial sustainability through reimbursement and funding.

Even though AM helps reduce hospital expenses in surgery time and resources over the long run, administrators are still looking into ways to recoup the expense of AM equipment and personnel more quickly. In addition, the health insurance industry is working on guidelines that support standards of care that will become reimbursable.

The SME report also mentions the logistics of using additive manufacturing within a hospital. Issues include materials, establishing protocols, sterilization needs, and understanding the differences between types of 3D printing applications for models, guides, implants and maybe one day, tissues.

Other considerations include regulation.

The FDA now offers guidance on 3D printed medical devices. The guidance is focused on safety and product effectiveness, giving engineers a chance to examine FDA thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements.

A couple of the considerations are should the POC center be certified by a regulatory agency and how are operators certified to work with the machines?

And hospitals will require quality standards between designed and printed models regardless of where the products are made.

Engineers trained in 3D printing will play a key role in this arena in the medical industry.

Leslie Langnau
llangnau@wtwhmedia.com