Research & development (R&D) activities don’t offer an immediate return on investment, so there can often be uncertainty about how much funding to invest in R&D, and where exactly to invest it. Many stress the importance of the earliest design stages, so perhaps more funding should be allocated there. But a product can’t hit the market without validation and testing, so perhaps those phases should receive more funding.

Thanks to demand for quicker turnaround on new devices, there is a time crunch for medical device R&D activities. Move too slowly, and the product risks obsolescence. Move too quickly, and it may not achieve U.S. Food and Drug Administration approval. Or worse, it may contain a design flaw that risks a recall or endangers patients.

For that reason, OEMs turn to firms that provide R&D services when they lack the internal resources to develop a product or using their resources would be cost prohibitive. These companies provide the expertise necessary when the OEM doesn’t have the bandwidth or monetary resources, and they can be quite valuable because of their specialized knowledge and dedicated teams.

To get more insight on the trends and challenges impacting R&D services for medical device manufacturers, MPO spoke to eight industry experts over the past few weeks:

• Alex Beaumont, VP of Beaumont Technologies, an Erie, Pa.-based full-service partner for companies involved in development and/or manufacture of plastic injection molded products.
• Justin Bushko, principal at Concise Engineering, a Clearwater, Fla.-based provider of full product lifecycle development from eliciting requirements through to design transfer, manufacturing, service, and process improvement.
• Dan Kline, CEO of Novo Engineering, a San Diego, Calif.-based provider of product development engineering services from concept through pilot manufacturing.
• Jim Kelley, VP of research & development, Cardio & Vascular at Integer Holdings Corp., a Plano, Texas-based medical device outsource manufacturer.
• Jim Medsker, president of Keystone Solutions, a Kalamazoo, Mich.-based product development and medical device contract manufacturing company.
• David Schechter, president of Meddux Development Corp., a Boulder, Colo.-based partner for the design, development, and manufacture of complex medical devices.
• Mark Turner, president and managing director of Medical Engineering Technologies Ltd., a Dover, U.K.-based provider of medical and combination device batch release and design validation testing.
• Raghu Vadlamudi, chief research and technology director at Donatelle, a New Brighton, Minn.-based firm providing medical device design, development, and contract manufacturing services.

Sam Brusco: What are the biggest drivers of outsourcing medtech R&D?

Alex Beaumont: Medical OEMs may have a clear vision of the component(s) they need to make their potentially life-saving devices a reality, but may lack the specific knowledge regarding optimal design/DFM for an injection molded plastic part. They recognize finding a company with significant expertise in that area is critical to success while avoiding wasting time and money on acquiring skills and assets that may not be value-added to their overall organizational goals. These outsourcing partnerships make sense when both parties involved recognize each other’s areas of expertise and can trust each other appropriately.

Justin Bushko: At many firms, we see medical device development outpace current resourcing. Highly profitable projects (even those already reviewed for inclusion in an R&D portfolio) are often deprioritized or discarded because they are perceived as “not big enough,” when measured against other opportunities and the available bandwidth of internal resources. Thus, we see more outsourcing of these projects, so that firms can pursue other projects with greater growth potential or broader appeal. Larger firms have capability to expand internal resources more rapidly. They also have the budget to outsource when cooperation is not aligned with human resource growth plans. Unfortunately, small and mid-size firms tend to over-rely on R&D dollars to fund internal projects, rather than outsourcing to engineering partners. Firms with a development strategy and adequate financial support stand to make significant leaps over competitors, without assuming excessive risk.

Jim Kelley: From our perspective at Integer, speed to market, technology breadth and depth, and the ability to serve as a trusted, capable partner with the capacity and knowledge to quickly scale manufacturing are currently the largest drivers of outsourcing medtech R&D.

Dan Kline: Ready access to expertise that a company does not have or have enough of, or that they judge not to be strategically important. The classic example is a pharma company without device development expertise that needs to develop a combo product and outsources the hardware and software development. For some companies, the bandwidth need is variable, and they recognize hiring and later laying off engineering staff will have a negative effect on their core team. A feeling by engineering management that they need a “fresh” point of view is also a factor.

It is also easier to have a transactional relationship with a contract engineering firm than with direct employees. A company trying to enter a new market where their in-house team has no prior experience also favors an outsourcing model.

Some of the drivers based on current economic conditions include: A highly competitive labor market for engineers due to rapid growth of the established tech companies; a vigorous investment environment for technology startups that cannot meet target dates if they rely on building an in-house engineering team from scratch; and the trend toward virtual companies, looking for quick exits, that follow a strategy of outsourcing in virtually every aspect of their business. These companies prioritize speed and often prefer relationships that can be severed without much ceremony.

Jim Medsker: One key driver is bandwidth. Medical device OEMs often choose to outsource R&D to alleviate their resources from the burden of a new program or other key initiatives. Another key driver is specific expertise. Often, an outsource firm may have in depth, specific experience in the product space the OEM is looking to enter. This helps shorten the learning curve and product launch cycle. Yet another driver is cost effectiveness. R&D and product development programs are by nature finite. It is often more cost effective to plug in an entity to outsource R&D activities for the program’s finite timeframe. While the cost rate may be higher during the development program, the overall costs are far less than hiring a full-time team for a relatively short time frame.

David Schechter: Here are some primary drivers to consider when outsourcing R&D:

Don’t reinvent the wheel! It will always cost more and take longer to forge a new path while learning as you go. Hire a team that knows your technical space and can apply critical knowledge and experience to your program.

Control burn rate by turning fixed costs into variable costs. Development teams transition from initial discovery, where you need strong R&D resources, to late-stage development, when you need experienced manufacturing and quality personnel, and then to clinical operations, where you need to control burn rate.

You will need to develop and implement full operational capabilities, including warehousing, receiving inspection, cleanroom assembly, and finished-goods inventory management. Staff your operation with qualified personnel, who may be underutilized in the early stages as you go through starts and stops in manufacturing needs. You will also need to develop and implement a robust QMS to effectively handle functions such as Purchasing and Supplier Management, Material Controls, Production and Process Controls, Risk Management, and Corrective Action/Preventive Actions.

You will need an MRP/ERP system to manage materials, schedule work orders, and reconcile materials consumed in manufacturing. Additionally, an effective operational infrastructure evolves over time based on organizational experience and continuous improvement efforts.

Access a network of suppliers and leverage established relationships. Many early-stage companies overlook that suppliers willing to participate in early development are choosing to make a long-term investment in the success of your product and company. Suppliers use considerable resources in delivering quick-turn prototypes, aligning manufacturing methods, resolving design issues, and expediting delivery.

An effective partner can put together a strategy unique to your product and company’s needs. Most importantly, ask how many people on your team have taken a program from start to finish and have experience with all aspects of product realization. The right partner has collectively executed hundreds of programs and can bring relevant experience in all aspects of product realization.

Mark Turner: Every project in the world has very tight deadlines. This produces a conflict in the medical industries where accuracy and comprehensive consideration of many pertinent factors are required.

Outsourcing of product validation and testing allows access to increased resource for the test work. More importantly, an external lab is likely to make you think more deeply about test protocols at an earlier stage. This can feed back into physical design and material choices at a time in a project when changes won’t cause significant delays. The external laboratory brings knowledge, experience, resources, and an extra pair of eyes on risk analysis. Additionally, small companies will have infrequent contact with regulators. It is possible the external laboratory has more recent experience of requirements.

Brusco: What benefits arise from medtech industry and academia partnership?

Beaumont: Academia is research-driven and often able to find a new solution to an existing problem. Research teams generally have the freedom to explore new areas and are less influenced by tribal knowledge or industry norms.

Bushko: We have found these collaborations are a double-edged sword. Firms which tend to benefit from such partnerships have a small and emerging, yet patentable portfolio of IP, which can develop into multiple projects. The result is often the commercialization of a license or academic patent(s), but not commercialization of an actual product. Historically, academia (particularly via incubators) positioned themselves as having resources to support small entrepreneurship communities by assisting them with advancing their projects. These ecosystems, though present for decades, have only begun to consider the true needs of an entrepreneur, rather than their own interests (e.g., grants, patents, funds from companies due to clinical partnerships, etc.) Because academia has viewed the entrepreneurial medtech community as a profit source, entrepreneurs who seek this type of partnership should take pains to ensure they remain mutually beneficial. They should also keep in mind the end game of any partnership (acquisition by bigger firms). Their own results must be strong enough to warrant these firms’ interest and engagement.

Kelley: When the medtech industry partners with academia, access to a broader network of research and enhanced access to cutting-edge technology are just a few benefits for both sectors. The medtech industry has the potential to benefit from a partnership with clinical and technical thought leaders, while academia benefits by gaining access to a commercialization pathway.

Kline: For a relatively small investment, the company gets their brand in front of promising engineering students. Through sponsorship of senior projects, clubs, internships, guest lecturing, and visiting professorships, companies can identify promising students before making a hiring decision.

Most universities have technology licensing programs that can be a cost-effective resource for device companies to advance core technologies or get a running (or jogging) start on newer technologies they believe could be strategically important. In the ideal case, the company gets access to a new technology that is reasonably well characterized as a result of basic research the company would consider too risky to undertake on their own. The commercialization of that technology, however, is in the company’s core competency.

Another advantage to cultivating an academic partnership is access to graduate students who have been exposed to cutting-edge research in a field of interest to the company. Smaller product companies typically can’t fund this type of activity internally. If familiarity with core technologies is the priority rather than industry experience, hiring graduate students can be much more cost-effective than recruiting from industry.

Medsker: A substantial amount of new technology and product ideas come from academia. Academic entities with presence in healthcare are significant sources for new concepts. An effective partnership is formed when an academic institution joins forces with a medtech partner. Academia creates the ideas, the medtech partner drives the idea across the goal line. By working together, the ideas formed on the front lines are developed into safe, compliant, and effective products. Additionally, academic institutions with healthcare programs and resources can serve as an initial location to trial developed ideas. The partnership between academia and the medtech industry creates an ecosystem that ensures accessibility to new medical device solutions.

Schechter: Academic research continues to support and initiate significant breakthroughs in medtech. Partnering with academia can further define your core technology and de-risk your development path. Collaborations with academic institutions may also provide access to non-dilutive funding through STTR/SBIR grants or state-supported funding mechanisms. Academic institutions may also be able to provide access to key clinicians and assist with clinical studies.

Raghu Vadlamudi: University/academic partnerships are integral to developing cutting-edge medical devices. “For profit” companies do not develop new medical devices unless there is a huge market. There is a need in the medical device industry to provide solutions for rare diseases and pediatric disorders. Universities with government grants and “not for profit” companies can make a difference in these areas.

Brusco: Are medtech companies embracing “open innovation” during R&D?

Beaumont: Many companies are embracing open innovation with the goal of sharing knowledge to help achieve life-saving breakthroughs at a faster pace. The largest caveat here is the issue of proprietary knowledge and patent protection during this collaboration. Balancing progress with profit is a delicate balance, requiring trust, mutual respect, and appropriate legal protections to ensure potential legal issues don’t obscure the bigger picture.

Bushko: In our opinion, very unevenly. Big players prefer to own product concepts outright and acquire as rapidly as possible once value in the project or product is apparent. Entrepreneurs who can secure their own funding and support are unlikely to join these circles unless their idea is simply too big to pull off on their own. That said, entrepreneurs involved in a program run or supported by a top 30 medtech company or a VC conglomerate may benefit. Goals for such “open innovation” for the entrepreneur includes satisfaction in the subsequent engagement, extraordinary support, or even a potential acquisition and exit.

Kelley: Open innovation is core to medtech R&D outsourcing. As medtech companies look to expand their product portfolios and accelerate time to market, they are increasingly relying on innovation and technology developed by external partners.

Kline: Both “open source” and “open innovation” development approaches offer great promise. Benefits can include more rapid development, increased innovation, and the creation of a marketplace around a new technology. However, there are software licensing conflicts, software verification and validation, and commercial transactional issues to deal with that can discourage these approaches for medical device companies—particularly smaller companies. Some larger medical device and pharma companies have embraced the idea and have the resources to manage the challenges.

At a minimum, embrace the concept behind open innovation—looking outside your company and its experience for relevant, existing solutions. The default assumption should always be an analogous problem has already been solved either within or outside of your industry. We have numerous examples of leveraging our knowledge of the thermal inkjet industry to medical applications. Without that prior experience and looking outside, we might have tried to reinvent that wheel.

Traditional product development includes voice-of-customer exercises in which target customers are interviewed (after appropriate releases are signed and compensation arranged) to solicit feedback on a specific piece of hardware or software under development. Conscripting existing employees—who have existing agreements to assign the rights to any IP they develop—into a focus group can also be a great resource for useful feedback or innovative ideas from beyond the core development team. Using open-source hardware or software for internal development purposes, but creating original designs for incorporation into the commercial product might be a viable strategy for smaller medical device companies.

I look forward to retrospective analysis of the amazing innovation, cross-company cooperation, and open sourcing of hardware and software inspired by the current pandemic. The incredible drive individuals and companies to contribute to solving or ameliorating the situation was very exciting to witness. The crowning achievement was development of multiple vaccines in an unprecedented timeframe. I am interested to see whether any of this experience will translate into new models for development or changes in regulatory approaches.

Medsker: Many medical device OEMs are embracing open innovation. While this runs contrary to the quite common closed/proprietary approach, it is often an effective means to gain traction in a program. There are two primary categories of open innovation. One is known as “inbound” or “outside-in.” In this case, outside ideas are sought and brought into a company, often via strategic collaboration, acquisition, or licensing. The other is “outbound” or, “inside-out.” A company will bring in and assimilate technology from the outside. When effectively executed, the company and its partners can experience significant gains not possible with the traditional closed and internal approach.

Schechter: With the advent of robotic surgery, advanced imaging, and navigational technologies there is a shift toward complex integrated systems that touch all aspects of the patient experience, from pre-procedural planning to post-procedural follow-up. To provide the best integrated solution, medtech companies are embracing “open innovation” and collaborating more and more so systems communicate seamlessly and work together.

Brusco: What effect is the shift toward value-based healthcare having on R&D approaches?

Bushko: Value-based healthcare is an inevitable shift. However, it is happening slowly and is influenced by numerous and unpredictable political and economic drivers. If doctors’ rates per procedure drop and outcomes are not proven to be better, hospitals will no longer accept high prices for run-of-the-mill products. We predict insurance codes will continue to remain stagnant or even drop, forcing companies to orphan projects if they are not deemed as profitable as other opportunities. This will limit R&D spending among commoditized product areas and shift focus toward higher-value opportunities. 

Kelley: Value-based healthcare is forcing device companies to consider cost and manufacturability across the entire supply chain much earlier in the development cycle. Design for manufacturability is critical to controlling costs and device companies increasingly rely on component and subassembly suppliers to lean out processes and provide feedback on design trade-offs.

Kline: In some ways, the shift toward connected devices, closing the loop on patient compliance/adherence, the cloud, and data analytics facilitate, and are driven by, value-based healthcare trends. It’s a bit of a positive feedback loop. If the concept is to measure value, it is critical to cost-effectively collect and analyze the data.

Medsker: Value-based healthcare definitely changes the stage for R&D efforts in the medical device arena. Value-based healthcare incentivizes healthcare providers to provide improved outcomes short- and long-term while reducing costs. This is a change in direction from the historical fee for service approach. This drives changes for healthcare providers and medtech companies, especially in up-front R&D efforts. Development teams now must have increased focus on (and participation from) the entire ecosystem involved in a device or treatment. Early involvement of clinicians and patients is key. The R&D lens must be expanded to include a more holistic long-term view for the entire patient population. It also needs to include not only improved outcomes, but also product lifecycle costs.

Schechter: New clinical solutions must be delivered in a way that translates into increased productivity and efficiency, avoidance of costly complications, or the ability to economically treat patients that we couldn’t otherwise treat. There is a shift toward thinking about cost-efficiency throughout the patient treatment paradigm, not just focusing on a specific device’s role. Early R&D efforts should provide an efficient and optimized clinical workflow with a goal of reducing costly complications and repeat procedures. The economic benefits and justification to payers should be clearly outlined at the R&D effort’s start.

Vadlamudi: Value-based healthcare is directing the industry to provide point of care diagnostic services that minimize the cost of healthcare services. Wearable medical device technologies are another arena the medical device industry focuses on. This technology plays a big role in artificial intelligence and big data.

Brusco: How will approaches to medtech R&D evolve in the near future?

Beaumont: The availability of and access to data will continue to influence medtech’s evolution. Technology that can generate measurements and data points to create actionable and individualized treatment plans will continue to grow in priority.

Bushko: We predict medtech companies will seek growth outside of commoditized product areas—particularly those under $50M per year. Smaller to mid-sized companies might choose to develop line extensions within this area, but larger companies will likely abandon incremental advancement and go after higher-value opportunities instead.

Kelley: As medtech companies focus their design resources on core therapies, they increasingly partner with suppliers for turnkey design engineering of complex subassemblies, as well as access, delivery, and diagnostic devices. To reduce time to market and expand product portfolios, medtech companies are increasingly utilizing external R&D partners as extensions of their own R&D organizations.

Kline: Companies will adapt to an empowered, mobile, remote workforce in a competitive job market, which may trigger an increase in the use of contract development firms. The increased availability of large data sets will increasingly drive business models and device architectures.

Open innovation platforms like the Open Innovation Drug Discovery (OIDD) platform by Ely Lilly may accelerate the lab to drug (or biologic) development cycle—particularly if regulatory agencies adapt as well. AI/machine learning is also everywhere, and will be increasingly incorporated into devices, applications, and services.

Automation will continue to displace or augment traditionally highly skilled and largely manual procedures, which will have a direct impact on device architectures. Virtual and augmented reality may also be used to expose developers to prospective device users’ experience.

Medsker: A few of the drivers for these changes in approach include: value-based healthcare; the current pandemic; healthcare industry consolidation; and improvement in materials, processes, and sensor technology. The industry will continue to trend toward being more inclusive in development efforts and collaborate with all key stakeholders in the value chain. The pandemic has exposed global supply chain weaknesses. Systemic issues in the ability of the medical device industry must be responsive. This will drive new levels of efficiency-driven solutions, and encourage the medtech industry to rethink sourcing while developing new products. Approaches will also continue to evolve thanks to a number of advancements in additive manufacturing for prototyping and production. Sensor technology continues to improve at a furious pace, allowing additional tools to create smaller, cost-effective wearable devices.

Turner: There are continuously increasing regulatory requirements for medical devices. Many companies choose to work with consultants to help them through the maze. Often, these consultants know every aspect of the regulations, but they may not be experts on standards compliance testing for every type of device. Some companies might miss the free consultancy available to them from laboratories simply by asking for a test program.

Schechter: Medtech solutions are starting to involve more complex integrated systems that need to communicate and share data across platforms. Large OEMs are pushing to develop and install platform technologies that encompass the entire procedural suite and patient experience. To provide a seamless integration and incorporate competitive advancements, large OEMs will partner more and more with technology innovators to expand the capabilities of their installed platforms.

Vadlamudi: AI, big data and digital health will transform the R&D process tremendously in a positive way. These technologies will provide information readily to the innovators to improve existing products, and to healthcare providers to monitor patients’ health in order to provide appropriate treatment.