24 Feb #OrthoInsider feature interview Brandon Bendes Co-Founder & President, Woven Orthopedic Technologies

A global pandemic that severely impacted elective surgery, supply chain challenges and an evolving regulatory landscape have all combined to disrupt the orthopaedic devices market in the past two years.

While the industry overall is still returning to pre-COVID levels, the 2022 outlook for some device manufacturers is already reflecting the positive effects of pent-up demand. 

Woven Orthopedic Technologies is one of those businesses. Their flagship product, the Ogmend® Implant Enhancement System, leverages a unique biotextile to help surgeons overcome the challenges faced when performing surgery in compromised fixation scenarios. Their solution works like a wall plug to enhance stability at the screw-to-bone interface and provide surgeons with the ability to achieve strong fixation in difficult, unpredictable circumstances. 

A Phase I launch in Europe in 2019 saw Woven Orthopedics enter the UK, Spain and Italy with significant success. However, the obstacles created by the COVID pandemic required unique maneuvers to continue placing Ogmend into the hands of surgeons.

We spoke to President and co-founder, Brandon Bendes, about how Woven successfully navigated a time of flux, delivering increased product adoption and the market outlook for the rest of the year and beyond.

How did you deal with the mass postponement of elective surgeries and procedures during the pandemic?

“We were drastically impacted by COVID because of the delays/cancellations in procedures as well as reduction in hospital access. A lot of hospitals had also stopped evaluating new products for use because of disruptions to normal operations and change in priorities to focus on caring for Covid patients.”

“With a new technology, the primary goal is to promote use so that you can prove the advantages providers will receive by using your product. When you can’t do that because of government enforced restrictions, the only feasible option is to implement strategies that place you in a position to succeed when markets eventually reopen.”

“We worked closely with Ortho Consulting Group to evaluate new markets and potential partners, investigate new geographies, evaluate reimbursement rates and price lists, and take the steps necessary to ensure we could rapidly generate adoption in whichever markets opened first, as soon as markets were ready to reopen. Nobody knew which markets would open and when so we investigated opportunities across Europe and in the Middle East.”

“Time will tell whether the strategy will succeed but so far, we experienced a huge uptick in use of our product at the end of 2021 and again in January. With Travel now reopening, we’ll be able to support surgeries personally soon and are thus very optimistic that this pandemic is continuing to move behind us.” 

How have you overcome logistics disruption or supply chain issues in unprecedented times?

“Fortunately, we have not been impacted by supply chain issues as much as other manufacturers. We were lucky to have owned a large stock of raw materials so our supply chain was only really disrupted by longer manufacturing lead times due to labour and facility protocols.”

“In fact, we’ve moved in the opposite direction from most. Working closely with Ortho Consulting Group, we took some of the slow time to optimize our logistics and procurement processes so that between the uptick in volume orders and more efficient operations, we were able to pass along some cost savings to our markets while other industries were seeing increases.

What impact has Brexit and wider regulatory changes had on your approach to the British and European markets?

“The new laws going into effect – both Brexit but also the transition to MDR and the reduction in notified bodies in general – have major implications. The biggest challenge we’ve faced is with regards to updating our systems and documentation to prepare for MDR. The cost and effort is enormous but I’m proud of our team for the work they’ve done thus far.”

“With regards to Brexit specifically, Ortho Consulting helped us manage Brexit. Through their UK Responsible Person service, we’ve had minimal disruption. They facilitated the transition process step-by-step and we haven’t noticed much of a difference.”

What are your goals for growth in 2022? 

“Our goal for 2022 is to continue executing the market entry strategies put in place during the pandemic so that surgeons have access to Ogmend for their difficult fixation scenarios. We’re excited about the rapid adoption we’ve experienced since Q4 of last year so we’re looking forward to  hoping to carry that momentum in 2022.”

“Because of Ortho Consulting Group’s help, we will be available in a lot of new markets in 2022, with surgeons in Switzerland, France, Germany, the Nordics, and the Middle East gaining access to Ogmend.”

“Furthermore, hospitals were impacted financially during the COVID pandemic so we’re not only thrilled about the clinical benefit we can provide to surgeons and patients, but we’re also delighted to play a role in helping hospitals recover financially.”

Which other markets will you be prioritising as part of your commercialisation plan?

“We are moving towards execution in a number of markets within the Middle East and Southwest Asia.”

“Clinically, there is a very high rate of compromised fixation scenarios due to higher incidence of comorbidities such as diabetes, vitamin D deficiency, and high rates of smoking. Overall, these lead to a higher prevalence of individuals with poor bone structure or poor bone healing and therefore a large number of surgeries that could benefit from the use of our product.”

“It is also our goal to target some of the less fortunate regions where premier fenestrated screw systems or some of the more high-priced alternate techniques are too expensive.” “One of our long-term goals is to enable these less fortunate regions to use basic fixation systems in conjunction with Ogmend to deliver the same level of care those with premier-level fixation systems can deliver.”