Over the past 12 months organisations around the world have had to adapt to successfully navigate through the global pandemic, meeting ever-changing customer needs and overcome the unexpected. During this period we continued to innovate, building a dynamic business and investing in the talented team at Synergy Spine Solutions with additional resources in support of our existing and new distributor partners in order to deliver continued growth in the future.
As we head into a new year, we’re looking back at the key milestones and achievements from 2021 that have laid the foundations necessary for success moving forwards.
Growth in our leadership team
In February Tim Hein joined Synergy Spine Solutions as VP of Sales and Marketing. Tim brings more than 25 years of experience in leadership roles at LDR, Zimmer, Medtronic, Kyphon and Paradigm, and has been a key sales and commercialization leader for Mobi-C, resulting in an ~$1B Zimmer acquisition.
“2021 was a year of continued adaptation, growth in our business and preparation to expand and enter into new markets in 2022,” said Tim. “The Synergy Disc value proposition of providing cervical alignment and balance with natural motion resonates globally and support our global growth strategy.”
The Synergy team grew in October with the addition of Michelle Hackmann, VP of Regulatory and Quality bringing more than 15 years of experience in product development, quality engineering and assurance, regulatory affairs, and strategic leadership within the medical device industry to the role.
Michelle said, “I am very excited to be part of the Synergy Spine Solutions team, where the depth and breadth of knowledge, expertise and passion are exceptional.
“I believe the product offering is a market differentiator in optimizing cervical spine solutions to improve the quality of patients’ lives around the world. I look forward to being part of this team to expand the global presence and impact of Synergy Spine Solutions.”
Sales and marketing
Global Synergy Disc sales increased by 25 per cent year-on-year in 2021 with expansion into Ireland, Belgium and Portugal.
“Despite the challenges we encountered in 2021 the EMEA team delivered quarter-on-quarter growth across the region with more than 200 cases, and this was hugely pleasing,” said EMEA Sales Director Matt Woods, of Ortho Consulting Group. “We’ve built and continue to grow excellent relationships with our distributors across Europe, welcoming and onboarding new partners while the UK finished the year as the number one European territory.
“As we look to next year, we’re looking forward to a return to travel, supporting our existing partners with in-country workshops and at events, and driving Synergy Disc adoption and preference across Europe, the Middle East and Africa.”
In November we were also pleased to announce Synergy Spine Solutions expanded its presence in Latin America through the addition of Healthcare International Partners, LLC as a commercialization partner. This process is already underway, with approval in Argentina and Mexico expected in early 2021.
Also joining the team as Director of Business Development (Asia Pacific) was Jon Mills, who has had an extensive and hugely successful career in orthopaedic and spine sales for more than three decades.
This includes founding LMT Surgical, which has been providing products and services to the orthopaedic and spine communities in Australia and New Zealand for more than 20 years and distributes the Synergy Disc in Australia & New Zealand.
In May Synergy Disc Replacement rebranded as Synergy Spine Solutions, positioning the company for the next phase of investment and growth which will allow us to support our partners, customers and expand our global presence.
This included a new brand identity, logo and website with an on-demand distributor resource portal and new marketing resources to support our distribution partners around the world and highlight the clinical of the Synergy Disc.
The digital roll out of the new brand identity and resources was amplified on our social channels with an ongoing digital marketing campaign to highlight our mission to identify and commercialize innovative spine technologies that help surgeons improve their patient’s quality of life and advance the standard of care.
Delivered by Ortho Consulting Group, an enhanced digital presence allowed us to engage with and support our global community of surgeons and partners, and to highlight the clinical benefits of our flagship Synergy Disc to potential new customers.
Product development
Led by Medical Device Product Development Engineer Bjorn Rindal, the Research and Development team at Synergy Spine Solutions completed development of the InLine Synergy Disc Instrument Set. These instruments will introduce many of the recommendations from the clinical experience with the Synergy Disc.
This includes a reduction from two trays to a single tray with an inserter that fully disassembles for reprocessing. The new tray will feature a universal inserter with adjustable stops and the addition of a slide hammer, and streamlined organisation of the pins, trials and pilot cutters in a caddy. The first InLine Synergy Disc Instrument Sets are expected to enter the market in January 2022.
Clinical
The Synergy Disc 1-Level IDE trial, a multi-center, prospective, non-randomized, historically controlled study, launched in the US in February and is now active at 18 sites across the country.
The study, whose aim is to demonstrate that the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management, enrolled it’s 50th patient in December.
Enrolment is accelerating and another two sites are expected to be active by the end of January. The study involves some of the USA’s leading spine surgeon thought leaders and arthroplasty experts.
Led by Jane Jacob, Vice President, Research and Clinical Affairs at Synergy Spine Solutions, additional data are being collected in in Australia, the EU and the UK. These studies will support both MDR and CE Mark regulatory requirements moving forward for the Synergy Disc.
Quality and Regulatory
With European Union MDR regulations coming into effect on May 26, Synergy Spine Solutions underwent a successful Notified Body audit resulting in the continuation of the CE Mark for our products and QMS.
We have made strong progress on MDR compliance while continuing the MDD to MDR transition. This includes regulatory clearance for our company name change from Synergy Disc Replacement to Synergy Spine Solutions.
Finally, we have made investments in the quality organization by adding a Quality Technician to assist with Quality Assurance and QMS activities.
