The unprecedented scope of the COVID-19 pandemic has had a profound impact on a countless number of industries, including medical devices. Orthopedics, a field that has traditionally proven to be markedly resilient in the face of economic and social turbulence, has been met with a new set of complexities.
“Orthopedics is facing an unprecedented moment,” said Carolyn LaWell, BONEZONE’s Chief Content Officer. “The spread of the coronavirus halted surgeries, disrupted supply chains, postponed deadlines and major regulations, delayed new product launches, and has forced many in the industry to navigate these challenges in a new remote and virtual world.” As COVID-19 continues to spread without a defined endpoint in sight, industry leaders must cope with meeting strategic deadlines and delivering the same quality of products amidst a backdrop of strain and uncertainty.
In a recent webinar hosted by LaWell, four members of BONEZONE’s Advisory Board met to discuss strategies for how orthopedic device companies can contend with the pandemic’s short-term impacts and emerge stronger when it finally comes to an end.
The webinar was moderated by Jeff Tyber, Founder, President and CEO of Tyber Medical, and featured Howard Levy, Vice President of Global Sourcing Instruments and Trauma at Zimmer Biomet; Sharon Starowicz, a Regulatory Consultant who spent 20+ years at DePuy Synthes; and Dale Tempco, an Industry Advisor, who formerly served in R&D roles at Medtronic.
Supply Chain Continuity Removes Uncertainty
While Zimmer Biomet’s Howard Levy remarked he wasn’t sure that uncertainty can ever be completely conquered, he highlighted his own response as a model for orthopedic device companies facing down precarious circumstances that have the potential to impact their supply chains. With operations located in China, Levy noted the outbreak unfolding there at the beginning of the year and began coordinating with the company’s supply chain partners and legal governmental teams in response. It was a self-described pivot from filling traditional sourcing and supply roles to pulling out the stops to communicate and strategize with Zimmer Biomet’s partners to operate successfully. Even with Levy’s quick thinking and team-building efforts, there were still unexpected and significant challenges, including a “mad scramble” to procure personal protective equipment (PPE) to protect company employees as well as partners who were expected to enter hospitals with their own gear. But through Levy’s leadership, the company was able to obtain the PPE and keep operations moving in the process through a coordinated team mentality.
Later in the webinar, Levy and Dale Tempco highlighted the irreplaceable need for close relationships between orthopedic device companies and their partners during uncertain times.
“We have COVID now, but before this, we had hurricanes in Puerto Rico and fires in California. We’re going to constantly be challenged with these types of disruptions to our supply chain, so forging those good relationships is more important than ever,” Tempco said.
While many companies are struggling to adapt to doing business online, Levy said the rapport Zimmer Biomet has built with its teams and various partners has made the transition easier. “At Zimmer Biomet, a lot of us have been around now for a decent period of time and, at least amongst the sourcing team and our suppliers, there’s been a good amount of continuity,” Levy said. “I don’t know if we have it like Phil Jackson used to with the Bulls and the Lakers, but we do have a lot of good continuity and relationships where our suppliers know us at this point in time and know where we’re heading.”
Open Communication Essential for EU MDR Compliance
Sharon Starowicz acknowledged that the delayed European Medical Device Regulation (MDR) was a significant challenge for orthopedic device companies. In April, the sweeping changes associated with MDR were pushed back a full year, resulting in changes that won’t go into effect until May 26, 2021. “So, what is the significance of that?” Starowicz asked. “Is that an opportunity for companies to take their foot off the gas? No, of course not.”
Between the typical regulatory demands that medical device companies face and the proverbial wrench COVID-19 has thrown in their day-to-day operations, it’s tempting for manufacturers to take their eyes off the ball. But Starowicz said that maintaining steadfast connections and open lines of communication with experts is crucial, especially as companies seek to understand nuances of maintaining products under the Medical Device Directive and shifting others to MDR.
“This is an area that manufacturers are still struggling with. With a product portfolio that lives on, there will be product changes, design changes, material changes and manufacturing changes,” she said. “And so, I think it’s really important for companies to maintain that connection with their Notified Bodies to have those discussions so there are no surprises, and to truly understand what those particular threshold changes are that would be those trigger points for the EU MDR.”
Brexit is posing another significant hurdle for manufacturers, Starowicz added. Likening the complexities of today’s uncertain business climate to a game of chess, Starowicz reiterated the need for connection and the continuity of communication for orthopedic device companies intent on maintaining smooth operations and growing during this time. “My message would be to remain very well connected to your business partners. Clearly, there’s a huge impact on design changes, so R&D is a key stakeholder in this and certainly supply chains are as well. It’s really in many ways like a chess game––mapping out all of the different timings and looking at different opportunities to leverage product portfolio, but also to look at all of these changes and recognize that the dates that we know today could very well be subject to change in the future. So, having that degree of connectedness and communication across all aspects of the business will be really key to ensuring compliance and an efficient route to marketing and uninterrupted product supply, as well.”
Success Requires Support of Goals, Not Uncertainty
When it comes to deciding whether to respond to uncertainty by putting plans on hold or choosing to tenaciously stick to them and work toward specific goals in the face of many unknowns, Jeff Tyber advised opting for the latter approach.
“Despite COVID, we are actively pursuing MDR,” Tyber said. “Since the pandemic hit, we’ve had three audits related to MDSAP, MDD audit and MDR audit. The big thing that we’ve been driving amongst our quality and regulatory R&D teams is that you can’t bet on the date moving. You just need to bet on what your plan is, what your execution is, and that’s really what you have to drive to––that’s an important piece. The second thing I would highlight is that the Notified Bodies, whether it’s TÜV or BSI or the others, or even the FDA, are in the exact same position as all of us are. A majority of them are remote.” With countless unknowns associated with the pandemic, Tyber’s advice seems designed to allow orthopedic device company leaders to remain productive and focused while they contend with challenges that seem to multiply and evolve by the day.
“It’s important to ask how to manage that perspective with company internal audits as well as being audited by regulatory health authorities,” Starowicz stated after agreeing with Tyber’s point. “Particularly for internal audits, it’s going to be really important to look at feasibility––not every audit can be done remotely––and having good risk management principles applied to what would be prioritized in terms of those audits. There’ll be a lot more in the pre-planning phase to really make those audits effective.” Starowicz went on to say that everything from record-sharing to preserving confidentiality during audits are details not to be overlooked while pursuing plans during times of uncertainty.
Remote Meetings Need Focus
Countless companies are being forced to adapt to bringing meetings online to digital platforms, like Zoom. According to Tempco, keeping teams engaged and on-task should be a vital and pressing priority during uncertain circumstances for orthopedic device companies.
“I’ve noticed it’s more important now than ever to have good project management skills when managing these meetings. I see meetings with 10, 15, 20 people and, despite the agenda, all of a sudden people just start talking and go into a problem-solving mode. Some of the engineers go off and talk about some issue and everybody else on the conference call, what do they do? I’ll say it kindly––they multitask and go off doing something else.”
At times when cohesion, follow through and engagement are needed most by orthopedic teams, the scattershot nature of many digital meetings poses serious threats to progress, Tempco said. “I’d say more than ever, when you have these larger meetings and conference calls, that you need to have an agenda that they should go through very quick. Ask ‘Are you on track to hit your date for this task?’ ”
Tyber later added that he finds allowing his teams to communicate in ways other than video conferencing are helpful and effective, such as phone calls and texts. Emailing, Tyber mentioned, is currently being discouraged as a communication method prioritized lower than calls, texts and video conferencing.
Opportunities Await Orthopedic Device Manufacturers
While some orthopedic companies have pressed the panic button this year by going into defense mode, instead of focusing on developing new technologies and products, Tempco said that the current business climate isn’t the time for shrinking away from opportunities and goals.
“I see that now more than ever, you really need to be in tune with not only what the customers want, but also what your business needs to make to develop successful products,” he said. “To develop successful products post-COVID, it’s going to be more important than ever to really document and understand what it is you’re trying to develop, as well as restrictions and what the goals are for both the customer and the company.”
At a time when a seemingly endless array of minute and hugely significant details alike can easily get lost in the shuffle, Tempco advised orthopedic device company leaders to double down on thoroughness while maintaining operations and coming out with new products to meet customer needs and business needs.
Levy noted that a strong display of leadership would help orthopedic professionals, and thus companies, maintain a forward trajectory.
“This too shall pass,” Levy said of COVID. “There’s this juxtaposition a little bit between how do you keep things normal in a surreal world. But at the same point in time, I think we, as a leadership group with our people and with our teams, need to keep hitting the things that we said we were going to hit as much as we can and respond flexibly, accordingly, and do it in the right way.”
Patrick McGuire is an ORTHOWORLD Contributor.