This article first appeared in Healthcare Tech Outlook.
Part 1 focused on key consideration factors for companies looking to expand their 3D printing solutions into the healthcare space. Part 2 outlines a 5-step approach for successfully moving it into the healthcare vertical.
While there are various methodologies for vertical expansion, our approach emphasizes the need to consider the unique dynamics of the healthcare industry and moreover the specifications of 3D printing in healthcare. Additionally, our approach looks to minimize risk while maximizing the clinical benefits of the solutions. Details of each step are described in the following sections.
Step 1: Define Your 3D Printing Healthcare Solution
The objective here is to paint a clear picture of what your 3D printing offering to the healthcare industry looks like. Is it a product or a service? Depending on your current 3D printing solutions, it may be more feasible to offer one over the other to leverage existing capabilities. You will also need to define the type of 3D medical application to focus on—today this ranges from surgical guides and prosthetics, to educational tools and pre-surgical simulation models. The last key activity is to determine who will be using the 3D printing solution, from both a provider and consumer standpoint (for some applications the consumer is the clinician while for others it is the patient). The output of this step is a clear design of the product or service you are providing.
Step 2: Understand the Healthcare and 3D Printing Industry Dynamics
Based on the product or service you defined in Step 1, you will then need to understand the various factors and dynamics unique to 3D printing in the healthcare industry as they will have a significant impact on the outcome of the new solution. A list of key factors to understand are outlined below. Additional detail for each factor is covered in Part 1 of this article.
- Printing Software & Printing Materials: The associated technology and material used to deliver the solution will largely be dependent on your specific 3D printing application, e.g. material durability, biocompatibility of materials.
- Regulatory Issues: Depending on the application, you may need to secure FDA approval for your solution.
- Intellectual Property: As more players enter the 3D printing space, IP implications become increasingly important. Copyright protection can be generally obtained for CAD design files and patents can be obtained for new or novel products or processes to prevent others from making or selling products or processes covered by the patent.
- Reimbursement: Reimbursement eligibility by the government or private insurance companies will depend largely on whether the 3D printed products are determined to be medically necessary, and whether they provide a substantial clinical benefit.
- Privacy: Guidelines, such as digital imaging and communication in medicine (DICOM) standards that deal with security issues, are evolving and continuing to be published by organizing bodies in healthcare.
- Liability: Liability scenarios in 3D printing are different from traditional “manufacturer” based chain of sale as the number of “products” are not aligned. Product liability law will continue to evolve as 3D printing disrupts traditional manufacturing.
Figure 1: Expansion of 3D printing into Healthcare is comprised of 5 major steps
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Step 3: Determine the activities for expanding into Healthcare
After defining your 3D printing medical solution and understanding the various healthcare industry specific dynamics from step 1 and step 2, you then need to determine what activities need to be completed to bring your solution to market. This includes identifying and partnering with suppliers required for your solution such as software companies and 3D printing materials vendors. It also includes activities related to gaining regulatory and FDA approvals, if needed. From an IP standpoint, additional steps may be necessary to determine what can be patented or copyrighted and to protect your solution from infringement. From a reimbursement standpoint, partnering with payers and determining what they require for coverage of the 3D printing solution will also be crucial to the viability of your solution. The output of this step is the set of activities needed for developing a market viable solution while addressing healthcare specific considerations.
Step 4: Develop the plan for making the expansion real
Once the set of activities required for developing the 3DP medical solution have been determined, the next step is developing the roadmap for bringing the solution to market. The roadmap needs to take into account the duration required for each of the activities, the dependencies across the set of activities, estimated costs, and resource availability.
Step 5: Execute and adjust for changes in 3D Printing Healthcare
With the roadmap developed, the last step is execution. Understand that the industry is undergoing constant change with respect to the technologies, materials, players, regulations, reforms in both the 3D printing space and healthcare space. It is critical you remain abreast of these changes and their potential impact on 3D printed medical solutions. Staying in touch with the pulse of these changes will better prepare you to adjust for new activities needed or revisions of any parts of the offered solution.
The revolutionary new technology of 3D printing has boundless opportunities and potential in improving patient health. However, both the healthcare industry and 3D printing technology have many dynamic and complex factors which must be considered and thought through before embarking on a journey into this area. Using a well-planned approach for planning and execution is critical to ensuring successful expansion of your 3D printing solution into the healthcare space.
Jessica Lan is a healthcare expert at PA Consulting Group and Hui Jenny Chen, M.D., is a neuroradiologist at Stanford Healthcare and founder of 3DHEALS