Benefits and challenges of patient-specific design

The emergence of additive manufacturing and 3D software have unleashed growth in the patient-specific design industry, with the global healthcare additive manufacturing market expected to reach $27.3 billion by 2030. Patient-specific design is on the rise. 

This should come as no surprise if you consider the advantages. Personalized medical devices – where geometry, function or material align with the needs of an individual – are intended to provide better performance and results for the patient than a one-size-fits-all device. Patient-specific devices have been proven to improve patient outcomes¹ and reduce healthcare costs.²  

In this blog, you'll learn all about the benefits of patient-specific design and the challenges you should bear in mind when implementing this approach in your organization. 

Benefits of patient-specific design 

1. Improved outcomes

Patient-specific 3D-printed hip implants used to treat severe hip defects in re-revision cases lead to a higher rate of implant survival. Traditional approaches have had high failure rates while a patient-specific implant can yield implant survival rates of up to 98%.^3,4

Another example of improved outcomes is patient satisfaction with craniomaxillofacial implants. In one case, patient-specific surgical guides and models for mandibular reconstruction had an 87% satisfaction rate, compared to just a 50% satisfaction rate with conventional techniques.⁵ 

3D-printed medical implant

2. Predictability

This refers to the physician’s understanding of a specific patient’s anatomy. For example, additively manufactured patient-specific heart models helped 96% of physicians in one study get a better understanding of the patient’s congenital heart disease prior to surgery.⁶

3. Operational efficiency 

Patient-specific design can improve operational efficiency. For example, on average, using patient-specific instruments in total knee arthroplasty (TKA) can save five to seven minutes of the surgeon’s time.⁷ This makes surgery more efficient and helps reduce the cost of additional required steps, such as sterilization. 

4. Lower costs 

Patient-specific design can improve efficiency and reduce waste. Creating devices for specific patients can improve surgery efficiencies, and also eliminate the need to purchase and manage large inventories of mass-produced devices.

Challenges of patient-specific design 

Relying on off-the-shelf, mass-produced parts or those created using manual, handcrafted workflows, can result in devices that do not last as long, do not fit as well, and do not provide as optimal an experience for the patient. These limitations have created the need for faster, easier, and less expensive ways to take advantage of patient-specific design.

The challenges involved in creating functional, patient-specific devices include: 

1. Comfort and fit 

Patient-specific design must achieve optimal fit for a single individual. Less than optimal fit can cause a variety of issues, depending on the device. It may affect device performance and durability. More importantly, it may lead to patient discomfort or poor outcomes. 

2. Functionality 

Patient-specific medical devices offer functional advantages over stock alternatives due to their tailored nature. Design for customization demands meticulous attention to diverse anatomical variations while making sure the device still functions as intended. Factors such as strength, fit, and range of motion must be considered.

 

Patient-specific medical devices offer functional advantages over stock alternatives

3.  Technical knowledge 

Technical knowledge of anatomy, the requirements of the surgical procedure, design tools and manufacturing processes are required to make these workflows feasible. 

4. Biocompatibility 

Depending on where the device is used, in or on the body, and the intent of the device, patient-specific design must overcome a range of issues related to biocompatibility and promoting integration with natural tissues, which can significantly affect device durability, performance and longevity. 

5. Regulatory and quality requirements 

Patient-specific devices must comply with strict regulations to ensure safety, accuracy, and effectiveness for individual patients. This involves thorough testing, documentation, and adherence to specific guidelines, which can be time-consuming and costly. 

6. Cost 

Patient-specific design solutions need to keep the cost of design, materials and manufacturing processes in check in order to maximize access and opportunities for innovation. 

Start your journey with patient-specific design

The advantages of patient-specific devices are significant, but historically they've been expensive and difficult to manufacture. That's changed with the development of new digital workflows based on 3D printing, medical imaging and 3D design tools. With the introduction of these tools, patient-specific devices have become a technologically and economically viable choice in many healthcare applications. 

Oqton Freeform is the industry's most comprehensive software for complex organic design

If you're considering embracing patient-specific design, Oqton's software is your key to success. Learn more about our software for medical design and manufacturing.  

Sources: 

1. Choo YJ, Boudier-Revéret M, Chang MC. 3D printing technology applied to orthosis manufacturing: narrative review. Ann Palliat Med. 2020 Nov;9(6):4262-4270. doi: 10.21037/apm-20-1185. Epub 2020 Sep 24. PMID: 33040564. 

2. Tack P, Victor J, Gemmel P, Annemans L. Do custom 3D-printed revision acetabular implants provide enough value to justify the additional costs? The health-economic comparison of a new porous 3D-printed hip implant for revision arthroplasty of Paprosky type 3B acetabular defects and its closest alternative. Orthop Traumatol Surg Res. 2021 Feb;107(1):102600. doi: 10.1016/j.otsr.2020.03.012. Epub 2020 May 11. PMID: 32409268. 

3. A Custom-made Acetabular Implant for Paprosky Type 3 Defects. Baauw, Marieke, Gijs Gerard, van Hellemondt and Spruit, Maarten. s.l.: Orthopedics, 2016, Vol. 8.

4. Do custom 3D-printed revision acetabular implants provide enough value to justify the additional costs? The health-economic comparison of a new porous 3D-printed hip implant for revision arthroplasty of Paprosky type 3B acetabular defects and its closest. Tack, Philip, et al. s.l. : Orthop Traumatol Surg Res, 2020, Vol. 11.

5. Virtual Surgical Planning in Precise Maxillary Reconstruction With Vascularized Fibular Graft After Tumor Ablation. Wang, You-Yuan, et al. 6, s.l. : J Oral Maxillofac Surg, 2016, Vol. 74. 

6. Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study. Valverde, Israel. 52, s.l. : Eur J Cardiothorac Surg, 2019, Vol. 1. 

7. Dorling IM, Geenen L, Heymans MJLF, Most J, Boonen B, Schotanus MGM. Cost-effectiveness of patient specific vs conventional instrumentation for total knee arthroplasty: A systematic review and meta-analysis. World J Orthop. 2023 Jun 18;14(6):458-470. doi: 10.5312/wjo.v14.i6.458. PMID: 37377995; PMCID: PMC10292058.