SMITHWISE FINDS A NEW HOME ON THE MAINLINE

“Our Philly team has grown dramatically over the past few years and our office downtown was becoming cramped. Now, with a space nearly four times larger, we have room to work collaboratively without bumping elbows with the teammate at the next desk.”

Written by Daniel Henrich

Written by Daniel Henrich

Director of Marketing at Archimedic

Solving Early Stage Medtech Ventures’ Funding Shortfall

The funding gap that currently exists for early stage medtech is a real threat to continued innovation within the medical device sector. While there is no simple fix to solving this complex funding challenge, there are specific actions that affiliated parties can take to improve the situation.

Originally posted on Med Device Online

Written by Eric Sugalski, founder and president of Smithwise’

At the 2017 Pediatric Device Innovation Symposium established by the Sheik Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System, a diverse group of investors came together to discuss gap funding for pediatric innovation. It is well-known within the industry that early stage medtech financing has been dwindling in the past decade. The critical phase of translational research, which exists between grant-funded academic research and institutional investment, is particularly lacking.

Fig. 1 highlights the funding gap that exists for the life sciences industry. While the data used to generate this graph included both biotech and medtech, the trends illustrated here seem to hold true for the medtech sector alone.

Fig. 1 — Funding Summary for Life Science Investments

The symposium’s gap funding panel candidly analyzed the current state of early stage medtech investment, but, more importantly, it concocted a plan of action and discussed a series of recommendations for key contributors to the early stage medtech ecosystem. Below is a recap of the panel’s discussion.

The Role of Clinical Innovators

Unmet clinical needs are most often identified by physicians and nurses; early stage concepts and technologies are often pioneered by these same medical professionals. However, these clinical innovators, due to lack of time and resources, are unable or unwilling to invest in new medtech ventures. That said, clinical innovators are crucial to the flow of new medtech opportunities, and their contributions directly affect the quantity and quality of future medtech deals. Clinical innovators also can play a vital role in bridging the early stage funding gap if they:

  • Understand the Long Game — Often, clinical innovators believe that quick wins can be attained through a patent, a prototype, and a license deal with a large medical device manufacturer. Rarely does an established medical device company license and commercialize nascent medical device concepts that are loaded with risk. Most device innovators need to de-risk their concepts in order to gain traction among larger medical device entities. This de-risking process can involve facilitating clinical studies to prove the efficacy and economic viability of devices, developing new technologies to achieve accuracy levels and acceptable cost structures, and navigating complex regulatory and reimbursement pathways.

This process is a long one, requiring many different skill sets. While clinical innovators rarely drive these processes, it is critical for these individuals to gain insight into the timelines, operations, and budgets required so expectations are aligned at the onset of new ventures.

  • Team Up — Most successful medical device innovations arise from clinicians teaming up with technical and business talent. Deerfield Management’s proprietary analysis suggests that 15-25 percent of novel medical device technologies come from academic institutions, with the remaining coming from commercial incubators or serial entrepreneurs / management teams.

Onboarding the right team members can de-risk a venture from investors’ perspectives. The right team is able to produce a logical and capital-efficient process while providing a credible set of skills that will advance the new venture.

The Role Of Academic Centers

Many research universities and hospitals attempt to fill some of the funding gap through internal innovation efforts. In many ways, academic centers serve as some of the main facilitators and gatekeepers of medical device innovation. Academic centers can take the following steps to overcome the funding gap:

  • Be the Matchmaker — Universities and hospitals have adopted hack-a-thons as ways to connect clinical, technical, and business talent. These connections are essential, but are typically short-lived. Matchmaking between clinicians, entrepreneurs, and technical talent should be a continuous process.
  • Provide Support — While it is ideal to find seasoned serial entrepreneurs to take on and spin out new medical technologies from academic centers, these business leaders usually are in high demand and short supply. Academic centers often need to assist in making device opportunities “investor ready” before seasoned entrepreneurs are willing to take the reins. This assistance typically entails de-risking through building prototypes, thoroughly vetting IP, and mapping out regulatory pathways. Many academic centers have created innovation funds to facilitate such de-risking processes. When internal resources are limited, though, innovation funds can be used to contract industry experts who can efficiently perform these risk reduction processes.
  • Be the Dealmaker – While short-term licensing revenues tend to be the metric by which university tech transfer offices are evaluated, the self-reinforcing entrepreneurial ecosystems — as well as brand and reputation gains through innovative initiatives and future-entrepreneurs-turned-donors — can be far more valuable to academic centers in the long run. Implementing unreasonable terms for licensing new technologies is one of the greatest barriers to growth in the medtech sphere. Recognizing the immense value that entrepreneurs and investors can create post-licensing, and structuring appropriate terms that reflect this future value creation, can directly increase the number of opportunities and the investments that follow.

The Role of Entrepreneurs

Entrepreneurs driving new device ventures have many roles to play in strengthening the U.S. medtech industry.

  • Fundraise to Specific Milestones — Early stage entrepreneurs facing funding challenges will often accept any funding that might help start their development process. Unfortunately, many of these entrepreneurs will face a downstream funding gap if sufficient progress has not been made through the prior financing round. When entrepreneurs are raising funds, they should do so with particular milestones in-mind.

These milestones should be identified to reduce specific risk(s), which in turn might attract future investors to enter a round at pricing levels that will satisfy prior investors and board members. Entrepreneurs also need to be realistic about the milestones they are able to achieve with early funding levels. Andrew Elbaridissi of Deerfield Management confirms, “In the current funding environment, aligning cash uses with the most significant drivers of value is crucial. Failure to do so places future financings and company viability at risk.”

  • “Don’t be Wimps” – As suggested by CDRH Director Dr. Jeff Shuren, many entrepreneurs are excessively gun-shy about approaching regulatory bodies early in the process. The FDA and CMS offices are actively streamlining processes and creating new programs, such as Parallel Review for Regulatory & Reimbursement, which are not being pursued by entrepreneurs.

These programs are intended to help medtech entrepreneurs de-risk regulatory and reimbursement issues early in the process, and it’s in the best interest of entrepreneurs and the medtech ecosystem to participate in these reviews such that they remain in effect and continue to be optimized and expanded.

  • Do your Homework — Epidarex’s Kyp Sirinakis emphasizes the importance of researching your investors. “You want ‘smart money,’ not just money, so make sure that you have knowledgeable investors,” she says. Additionally, the relationship matters. Srinakis compares it to getting married: “You will likely be working with these people for a long time through ups and downs. There needs to be mutual respect and the ability to communicate on both sides.”
  • Plan, Plan, Plan — As John Parker of Springhood Impact Adventures explains, “Getting an innovative solution to the bedside is a long and difficult journey. It needs to be mapped out from start to finish, with the understanding that there will be traffic jams, detours, and roadblocks along the way. Sometimes, even the destination itself will change.”

Sirinakis backs up Parker’s claim, stating, “device ventures always cost more and take longer [than expected], so plan accordingly.” Developing the roadmap and trying to understand the timing and cost of all potential steps are keys to risk management. Since entrepreneurs typically need to get to market on a shoestring budget and timeline, it is difficult to bounce back from mistakes. “It’s important to do your homework on investors,” adds Sirinakis.

  • Get Help / Bring Talent to the Process — Getting help from mentors, advisors, board members, and industry experts can add value and challenge your assumptions. Parker asserts, “[knowledgeable] people want to help. Tap the wealth of the free or low-cost resources out there for device developers, such as the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) — it won’t cost you a lot.”

The Role of Investors

Early stage investors take on considerable risk due to clinical, regulatory, payer, and technical challenges. Consequently, these early stage investors are susceptible to “getting squashed,” or substantially diluted, during later-stage financing rounds. When considering these dynamics, it makes sense why few early stage investors for medical devices exist.

Some investors are taking a different approach to filling this gap. Impact investors, particularly foundations and other charitable organizations, primarily measure their investments by the number of lives saved or improvements in quality of life for specific patient populations. Consequently, these types of investors tend to lean towards ventures that are making a significant impact, rather than those that serve as an incremental solution.

“Just as no return-driven venture capitalist hopes to make only a little bit of money, no early-stage impact investor strives to only make a little bit of difference,” Parker states. “Mission-focused investors are still looking for an outsized reward for the risk they are taking – they are just looking for that reward to manifest as massively improved outcomes for patients and healthcare stakeholders.”

In addition to providing this vital gap funding, the early stage investment community can bolster the medtech industry in the following ways:

  • Get your Hands Dirty — Some of the most successful medtech investors are actively involved in contributing to the ongoing operations of portfolio companies. They provide valuable business connections, optimize go-to-market strategies, and ensure that milestones are being cleared in the most efficient means possible. A large part of an early stage investor’s role is to ensure that their portfolio companies do not fall into funding gaps down the road. This means structuring early stage financing to achieve specific milestones that will allow subsequent financing rounds to be achieved.
  • Utilize Investor Networks — Investors bring their valuable networks and industry contacts to the table. “This can not only help you as run into pitfalls,” Sirinakis suggests, “but it can help introduce potential acquires and partners… ultimately helping structure the right deal.”

The Role of Regulators

U.S. regulators play an important role in keeping the population safe and striving for economic efficiency in our healthcare system. Indirectly, they also are pivotal in bridging the medtech funding gap. The constraints, processes, and ambiguity imposed by our regulating bodies constrict investment interest. Below are some actions that regulating bodies can take to improve the funding gap:

  • Provide Reimbursement Clarity & Guidance — The FDA has created extensive guidance documentation to address questions and confusion within the medtech community, often providing requirements and suggestions for particular devices. Although payment for new therapies and diagnostics represents the most significant risk for early stage medtech companies, CMS has yet to provide this same level of clarity and guidance.

If a similar level of guidance documentation published by the FDA were to be published by CMS, it would provide the clarity for venture capital firms to invest more heavily in the medtech sector. Elbardissi explains, “The failure to couple reimbursement and regulatory pathways has long been a headwind in the medtech sector. This is emphasized to an even greater extent in pediatric devices, where small patient populations and an inability to gain orphan-like pricing and reimbursement represent a monumental impediment to investor appetite — which is critical to drive innovation.”

  • Incentivize Investment in Unmet Needs — Many patient populations with unmet needs could be addressed through medtech innovation. Pediatrics, for example, is one of the most underserved patient populations. The lack of research and resources available for pediatric populations often leaves physicians with few options besides using adult devices on this population. The FDA is well aware of these issues, and they have created pathways to streamline the regulatory process.

The Humanitarian Device Exemption (HDE) pathway is one initiative the FDA has implemented to stimulate device innovation for small patient populations. While some medtech companies have benefitted from this pathway, it has not created adequate incentives to stimulate investment in these small patient populations. Conversely, the Orphan Drug Act, a seven-year patent extension and a substantial tax credit for companies developing and commercializing drugs for rare diseases, has done a remarkable job in stimulating investment for ventures focused on underserved populations.

Fig. 2 illustrates the number of orphan drug designations since 1982. If a comparable program was enacted to create tax incentives and patent term extensions for medtech, a significant stream of investment would likely open. Removing the profit caps that currently exist for these small patient populations would also greatly incentivize activity in these sectors.

Fig. 2 — Orphan Drug Designations

The funding gap that currently exists for early stage medtech is a real threat to continued innovation within the medical device sector. While there is no simple fix to solving this complex funding challenge, there are specific actions that affiliated parties can take to improve the situation. Through discussions like those that occurred at the 2017 Pediatric Device Innovation Symposium, clinicians, entrepreneurs, academic institutions, investors, and regulators can connect, learn from one another, and plan for progress that will ultimately improve the U.S. medtech industry.   

The original article can be found here

GOVERNOR WOLF VISITS SMITHWISE

Governor Wolf and his team from Harrisburg visited Smithwise at our Philadelphia location.  There is strong interest from the State in building innovative companies that will drive job growth for local communities. Governor Wolf recognized the work taking place at Smithwise and our local clients as being a vital part of the innovation ecosystem in Pennsylvania.

During Governor Wolf’s visit, we discussed Towerview Health’s medication management platform, ZSX Medical’s laparoscopic surgical device, and Active Protective’s wearable airbag hip protection system.

We look forward to continued support from Governor Wolf in expanding health technology in PA.

TOWERVIEW HONORED AS FINALIST IN THE 2017 MEDICAL DESIGN EXCELLENCE AWARDS

“Being selected as an MDEA Finalist is a testament to the skill, dedication and innovation of the Smithwise team that developed the Towerview product in a six month period of time.” – Eric Sugalski, Smithwise CEO

Smithwise is pleased to announce that Towerview Health Medication Management System has been selected as a finalist in the Digital Health Products and Mobile Medical Apps Category of the 19th Annual Medical Design Excellence Awards competition. Finalists were officially announced in the May Issue of MD+DI (Medical Device and Diagnostic Industry) magazine. Winners will be announced at the 2017 MDEA Ceremony held Tuesday, June 13, 2017 in conjunction with UBM’s Medical Design & Manufacturing (MD&M) East event at the Jacob K. Javits Convention Center in New York. To learn more about the event, please visit: www.MDMeast.com

As a Supplier to the Finalist, Smithwise provided mechanical engineering, electromechanical integration, optical engineering, industrial design implementation, design for manufacturability and assembly (DFMA) and supply chain development.

The MDEA is the medtech industry’s premier design competition committed to recognizing significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. The awards program celebrates the accomplishments of the medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech—one innovation at a time.

“Being selected as an MDEA Finalist is a testament to the skill, dedication and innovation of engineering team that developed the Towerview product in a six month period of time.” Eric Sugalski, CEO Smithwise.

Unlike other design competitions that are merely styling contests, the MDEA panel is comprised of medtech experts, including a balance of practicing doctors, nurses, and technicians alongside industrial designers, engineers, manufacturers, and human factors experts. MDEA jurors comprehensively review entries based on the following criteria: the ability of the product development team to overcome all challenges so the product meets its clinical objectives; innovative use of materials, components, and processes; user-related functions improving healthcare delivery and changing traditional medical attitudes or practices; features providing enhanced benefits to the patient and end-user in relation to clinical efficacy; manufacturing cost-effectiveness and profitability; and healthcare system benefits such as improved accessibility, efficacy, or safety, in addition to providing attention to a critical unmet clinical need.

The 2017 MDEA Juror Panel selected 45 exceptional finalists in nine medical technology product categories. Products were judged based on design and engineering innovation; function and user-related innovation; patient benefits; business benefits; and overall benefit to the healthcare system.

Winners will be announced on Tuesday, June 13, 2017 at the 2017 Medical Design Excellence Awards ceremony. MD+DI will recognize the finalists and announce the Bronze, Silver, and Gold winners in each of the nine medtech categories, as well as present the Readers’ Choice, Best-In-Show, Lifetime Achievement Awards, and more! RSVP during your MD&M East registration to reserve your ticket. Admission is FREE but donations are encouraged to benefit VentureWell’s BMEidea, a design competition for biomedical engineering university students whose winners will also be announced at the ceremony.

For the latest news, tweets, videos, and info about #MDEA17 finalists and winner follow MD+DI on Facebook, Twitter, YouTube, and www.MDEAwards.com.

PROTOTYPES TO PRODUCTION: 5 STEPS TO A SMOOTH MANUFACTURING TRANSFER

The five steps discussed within this article identify what to expect, and how to respond as a team to move a well-designed device to volume production.

Originally posted on Med Device Online

Written by Jon Wenderoth, Lead Mechanical Engineer at Smithwise

Many new companies have a business model based on transitioning their product to high-volume manufacturing and distribution. Unfortunately, this is more complex than breaking out the parts from a working prototype and selecting a manufacturer. Mistakenly thinking the development is wrapped up at this point will cause schedule projections to be significantly off, and seed doubt in knowledgeable investors.

It is important to understand that these steps alone won’t fix the output from a broken development process; a house needs a solid foundation to remain standing. The entire evolution, from thoughtful design through prototypes and iteration, inherently becomes the footing for an efficient transition to manufacture. The five steps discussed within this article identify what to expect, and how to respond as a team to move a well-designed device to volume production.

1.  Prepare A Request For Quote Package

When it’s time to start shopping around for vendors, it is important to gather the necessary information into a concise Request for Quote (RFQ) package. Remember that everything is on the table at this point, so if a potential customer appears disorganized, unprepared, or generally unknowledgeable, it sends up a red flag that a project may involve significant hand-holding; prices will be adjusted accordingly. Having a complete, up-to-date database is in your best interest and will pay repeated dividends over the life of a product.

The RFQ package should start with an engineering Bill of Materials (BOM). This is the full parts list, including part descriptions, materials, proposed manufacturing processes for custom components, any secondary processes, quantities, file names, and revision tracking. For a contract manufacturer (CM), a complete BOM is a quick reference for the submitted parts that implies experience and attention to detail. If quoting at individual vendors for specific manufacturing capabilities, segment the data so they aren’t overwhelmed with extraneous information.

 

Prototypes To Production: 5 Steps To A Smooth Manufacturing Transfer

Above Image:  Zip-Stitch by ZSX Medical (zsxmedical.com).

Vendors also will need part files to know what they are quoting.  Stay away from sending any native file formats; in addition to document reference headaches, outside parties are less likely to attempt to modify CAD data without design tree information. Instead, identify which file formats fit a vendor’s process. For instance, two-dimensional process manufacturers (stamping, die cutting, water jetting, etc.) can usually work with 3D part files, but many prefer flat pattern DXFs, as these can feed directly into their machine software. Three-dimensional process manufacturers (molding, casting, multi-axis machining, etc.) need 3D part files, like IGS or STP.

If your project is like most development efforts, time is on short supply and quoting is begun prior to design finalization. This typically is ok, as long as general size and features are included within your files. Ensure some form of revision control is used, so when it is time to hit “go,” the appropriate files can be referenced. To summarize:

  • Compile an appropriate, complete package for each vendor.
  • Use revision control (dated files, revision numbers, etc.) that can be easily referenced.
  • Send the entire package at one time. A barrage of emails to sort through is inconvenient for the recipient and increases the chance that things will be lost.
  • Special operations/secondaries can be specified in the BOM. If further granularity is required, 2D control drawings can be generated.

2. Construct A Realistic Timeline

One of the key outputs from the RFQ and vendor selection process is schedule. Formal quotes come with lead times, so be clear on what these lead times mean — when does the timer start, and what is the deliverable when it stops?

Using injection molding as an example, imagine it is May 2nd, and a vendor quoted a five-week timeframe to T1 sample parts. If a purchase order is sent today, the first parts will arrive in early June, giving just enough time for each part to be packaged and sent to representatives at the big east-coast medical design tradeshow later that month. (At this point, if you’ve done this before, you are questioning the validity of this article.)

Unfortunately, this is a common trap new developers fall into when doing the right thing and trying to project into the future. The intent is there, but the data is skewed. In this simplified example, the five weeks are for sample part molding, not including shipping time, and other steps in the process are not considered. A typical timeline for this example part might be as follows, with up to several months added on to the five weeks quoted:

  • Final file delivery
  • Moldability evaluation1-2 weeks
  • Discussion & part modification2-3 weeks
  • Final review & tool design approval1 week
  • Tool construction & T1 samples5 weeks
  • Part evaluation, testing, and file updates2-4 weeks
  • Tool grooming and texturing2-3 weeks
  • T2 samples delivered1 week

For multi-part assemblies, using varied manufacturing methods, schedules become increasingly complex. It can be helpful to fully understand all the steps in a process and work backwards from a set deliverable date. With this approach, as the project progresses, it is clear what the longest lead time items are, and which milestones need to be met, so they don’t become a gating item.

3.  Finalize The Documentation Package

After vendors are selected and the product design is finalized, the documentation process discussed in step one will need to be repeated at a more discrete level. In addition to CAD files, this should include complete engineering drawings in PDF format. If working with a CM, assembly drawings should be included, with all pertinent drawing views and instruction to enable a third party to assemble the product.

This documentation is the engineer’s chance to identify areas that need specific tolerances, with critical dimensions for functionality and inspection dimensions for the vendor to verify. In many cases, a vendor will inspect all drawing dimensions; at the least, values identified as “inspection” will highlight their importance to the physical outcome of a part.

Don’t forget to update and send your BOM with the final files in a complete package. It is critical that vendors have easy access to the most recent documentation to avoid mistakes, and it is wise to include revision numbers on individual file names that can be cross-referenced to the BOM.

4. Manage The Design For Manufacturing (DFM) Process

At this point, the vendors have been sent the information they need, but the job isn’t done yet. There should be some degree of feedback from all manufacturers, but we will continue to use injection molding as our example.

After a few weeks, the vendor will have reviewed the files and provided a moldability evaluation. If a knowledgeable engineer or reviewer has been involved in the development, there shouldn’t be any show-stoppers here. However, if the vendor discovers that a critical feature can’t be molded due to geometric constraints, there may be some late nights ahead. Luckily, the tools haven’t yet been cut and there is room to pivot. Still, a sales team pushing to be first to market won’t appreciate the compromised schedule.

Regardless, expect there to be some feedback to incorporate into the design. Maybe an internal rib is moved to allow for a more convenient gate location, or the draft added to a snap feature isn’t sufficient for appropriate shutoff. When resolving these details, keep in mind that the molder doesn’t know the design intent of your parts, and their first suggestion will likely be the easiest (but not necessarily the correct) solution.

To that end, communication, especially with overseas vendors, can be painful. A phone call to discuss changes directly is often the most productive way of handling this, but this isn’t always possible. Discussion often reverts to “Powerpoint engineering,” where issues are captured and suggestions given within a slide deck. For these situations, we suggest the following:

  • Be clear and concise, and don’t forget there may be a language barrier. Label and date all files, as well as all comments.
  • Pictures, arrows, & colors: The “1000 words” philosophy applies here, too, and simple sketches often can suffice, rather than investing time in an exploratory CAD change.
  • Consolidate. If schedule permits, gather all the DFM feedback together to review instead of assessing it piecemeal. This is more efficient, and makes it easier to track responses. Provide 2D and 3D file updates in the same way (don’t forget to update your BOM with revisions).

Besides design issues, the vendor will be looking for approval of process-specific features, such as gate and ejector pin locations in a mold. Ensure there is an understanding of what approvals are needed and how they are provided; it is frustrating to believe a vendor is spooling up when they are actually waiting for a well-defined approval.

5. Inspect, Evaluate, And Adjust

Regardless of what anyone says, no custom manufacturing parts are going to be perfect immediately — that takes additional work. For this reason, a good development timeline should always build in a period to assemble and evaluate the form, fit, and function of a design. This is the time to find and correct any issues that arose during manufacturing. If schedule is very tight, it is always helpful to have a representative on site for rapid evaluation. Remember that the vendor will need approval prior to any volume orders (or final tool details, like texture application on molded plastic), and it becomes more costly for budget and schedule if changes are requested later on.

  • Ask for inspection reports from vendors. For production parts, these should be available and provide direct measurement of critical dimensions identified on engineering drawings.
  • Get all parts in-hand (preferably multiple sets). This includes electronics, fasteners, samples from each cavity in family tooling, custom cables, everything. Long lead time parts need to be sourced appropriately so they are all available.
  • Assemble and test: Leverage sample parts and inspection reports to assess functionality.

Testing may start as fit checks — ensuring a sheet metal bend is at the correct angle or fastener holes align — and then may progress to a functional assessment. Eliminate variables where possible to focus on the area in question, and don’t be afraid to do some destructive analysis if supplies allow. This is a valid justification for allocating multiple parts to testing; if a problem can’t be seen or understood, it may not be fixed appropriately. Regardless of how many are available, never be cavalier with the approach to sample parts. Identify a plan, and then inspect, measure, and record until all learning opportunities from a part have been exhausted.

Ensure all members of the design team are aligned before implementing any modifications. As with earlier updates, communicate changes in a clear and concise manner, as the cost and risk of change (and therefore mistakes) increase exponentially after vendors have fully tooled up for high-volume production.

These steps should provide some high-level insight into the effort required to transfer a product to manufacturing. While this is by no means a complete list of the challenges involved, hopefully it can equip hardware developers with enough knowledge to avoid the common headaches and get their product into production.

3D PRINTING PRODUCTION MEDICAL DEVICES — PITFALLS AND BEST PRACTICES

Many factors need to be weighed when implementing 3D printing within an evaluation, clinical, or production device setting. Because 3D printing is as easy as a click of a mouse, additional responsibility falls on developers to properly design, assess risk, or account for quality.

Originally posted on Med Device Online

Written by David Schoon, Director of Mechanical Engineering at Smithwise’s Newton office

Medical device developers use 3D printers religiously, to develop prototypes and to iterate designs, in order to rapidly learn and improve upon a product idea. Traditionally, these tools are used during the early stages of development. After prototyping is complete and the behaviors of a product or part design are understood and tested, the design is manufactured by a more economically viable method, such as injection molding, extrusion, casting, or metal stamping, amongst others.

However, there are circumstances under which 3D printing is a perfectly reasonable production method. These can be instances where production volumes are low, product margins are high, or there is a need to uniquely customize each design. While these may not be common scenarios for, say, a smartphone or a coffee mug, these factors can translate well to certain types of medical devices. Still, device makers need to be aware that there are precautions and processes to consider as a result of the unique risks associated with 3D printing manufacturing.

It’s likely that many developers with 3D printing exposure or experience already are aware of some of the common traits and risk associated with the process — FDM hole sizes that are significantly undersized, in accordance with claimed machine tolerances; photopolymerization materials that creep and dimensionally change over time when exposed to loading conditions; and DMLS parts that are saggy, droopy, or out-of-specification from the outset, due to poor build orientation and support material layout. However, these examples of common difficulties merely scratch the surface of what needs to be understood, from a risk perspective, when implementing 3D printing into a medical device design.

One difficulty that developers have encountered to this point is the particular dichotomy that exists between 3D printing — which can be associated with fast and loose development — and the regulatory standards and rigor imposed by FDA upon devices developed within a quality system. The ease with which one is able to generate parts through 3D printing inherently introduces risk.

In May 2016, the FDA released a draft guidance titled Technical Considerations for Additive Manufactured Devices. Any manufacturer or organization considering 3D-printed components during the development of a medical device should refer to this document. The guidance goes into detail regarding risk and other considerations related to 3D printing, as well as how to employ 3D printing within device development. Some of the risks and considerations discussed include:

  • Development drawings with critical dimensions can be overlooked, and/or parts can be printed without files being saved and documented properly within a Device Master Record.
  • Material behavior can vary significantly from datasheet specifications due to environmental conditions, build orientations, print machine variables, and other unanticipated factors.
  • Software workflow, material controls, and post-processing are important considerations to achieve repeatable and quality parts, and proper documentation and manufacturing flow charts should be generated to capture these.
  • Compared to traditional manufacturing techniques, there are feature size limits, dimensional variation based on technique, environmental conditions factors, and many factors affected by build orientations.
  • Material behavior, with respect to cleaning and sterilization, can differ from that of parts manufactured using traditional methods.

The FDA has presented workflow guidance detailing what needs to be controlled for a successful device submission when utilizing 3D printed components. Developers should plan to include proper design documentation, software workflow, material controls, post-processing controls, and testing considerations.

 

Flow Chart

 

The guidance should be consulted for finer granularity regarding each of these quality components. Additionally, manufacturers should heed these commonly overlooked considerations relevant to 3D-printed part production:

  • It is recommended that performance verification come from testing finished parts, or coupons that are produced using an identical process.
  • If possible, device files should be maintained and archived to an Additive Manufacturing File format, as described in ISO/AST 52915.
  • Workflows should be established to include part placement, layer thicknesses, printer accuracy, print speed, and the build layout within a print envelope.
  • Printer maintenance procedures should exist along with workflows to establish consistency between builds. These should be maintained within the Device Master Records (DMR).
  • All material information should be documented, including any process aids, like material support and crosslinkers.
  • Workflows should exist for any post-processing steps, such as the removal of support material. Depending on the use case, testing may be necessary to understand the effect this action may have on the finished part.
  • Process validation should be established. This can include monitoring and documenting the 3D printer’s environmental conditions to validate the machine process.

The FDA guidance is intended to induce a thoughtful approach that will yield a successful regulatory submission, and is catered towards the inclusion of 3D printed components within an end product. For a low-volume FDA evaluation or a clinical study, there may be economic factors that make 3D printing a desirable approach for component and prototyping purposes.  When weighing this approach, it should be understood that the burden is on the developer to establish sufficient rationale to claim equivalency between a prototype and a high-volume production method.

In certain instances, equivalencies can be rationalized fairly simply — for example, if a 3D-printed housing was used for a laparoscopic disposable within a human factors validation study.  However, if said device contained electrical or antenna components and was being used within a clinical trial or certification testing, there may be good reason to prototype with a production material.  Material differences could influence the EMC or antenna performance, and having to retest to IEC 60601 conformity could be costly and time-consuming.

In summary, many factors need to be weighed when implementing 3D printing within an evaluation, clinical, or production device setting. Because 3D printing is as easy as a click of a mouse, additional responsibility falls on developers to properly design, assess risk, or account for quality. As the FDA has only recently began to weigh in on 3D printing, developers and manufacturers would be wise to use pre-submissions when clarifications are needed.