30 Day Trial
ORTHOKNOW logo

ORTHOKNOW content is posted to these pages in real time.

Monthly compilations are available in PDF form.

Voice of Industry

Rapid, Cost-efficient Access to Products: Q&A with Jeff Tyber

 

Tyber Medical recently appeared on our radar as another company that is doing business differently, nowadays—it claims that it can help customers gain immediate access to differentiated products in three months or less, with no regulatory or timeline risk and no out of pocket R&D expenses.

Within 3Q and 4Q13, the company has received both CE Mark approval and 510(k) clearance for TyPEEK- and PEEK-based interbody spacers. It also markets products for trauma and extremities.

Tyber Medical’s customers are orthopaedic device companies, stocking distributors and hospitals/group purchasing organizations. ORTHOKNOW asked Mr. Tyber to explain the Tyber Medical approach.

ORTHOKNOW: Tyber Medical looks like a different kind of company. How would you describe it? Do many other companies share this method?

Jeff Tyber: To our knowledge, Tyber Medical is one of the first companies whose business is focused entirely on the private labeling or rebranding of full instrument and implant systems. We ultimately act as our customers’ outsourced product development, quality and regulatory assurance and manufacturing operations divisions.

Tyber Medical is a private-labeler OEM implant company that helps orthopaedic companies, large distributors and hospital organizations gain access to regulatory approved implants and instruments utilizing their own brand.

We design and develop full class II orthopaedic implant and instrument systems, verify and validate those systems using a QSR and ISO 13485 certified quality system and pursue and maintain both U.S. FDA 510(k) and ex-U.S. CE Mark regulatory approvals.

ORTHOKNOW: How has your R&D background affected the way you lead Tyber as President and CEO?

Tyber: I’ve had the privilege to lead the R&D efforts at several orthopaedic companies in developing the next novel technology. The common theme for each of these companies was to focus the majority of their energy towards novel differentiated products, with minimal focus on me-too products.

Unfortunately, surgery doesn’t work like that and the me-too products are required to support the novel devices in the OR. We can allow our customers to keep focusing on their novel R&D or core competencies while giving them rapid access to me-too products, without going through an acquisition or a long term license. Plus, they can brand the products as their own and seamlessly integrate them into their product portfolio.

My background, along with the team’s experience, helped us to structure Tyber Medical as an outsourcing partner. We manage every aspect from the product development, quality, regulatory and operation cycle. We leave the sales, marketing, product branding and distribution up to the client.

ORTHOKNOW: Tyber recently received regulatory clearances for spine products. The spine segment faces numerous challenges, today. What should spine companies do to position themselves for success?

Tyber: Not just spine but any orthopaedic company seeking to bring a novel technology to market should also look at the other components used to complete the surgical procedure.

For example, the majority of spinal fusion procedures use both a fixation device and a spacer component. Currently, there are a number of new start-ups with a new fixation device coming to the market, which means they’re only offering half the solution. They could gain rapid access to the missing component, capture more revenue per case and meet competitive threats by having a complete product portfolio.

ORTHOKNOW: What are your plans for Tyber Medical? Where do you see the company in year five?

Tyber: Today, Tyber Medical has a regulatory-approved catalog of 3,000 different interbody configurations. Our second product, which covers the extremity and trauma markets, is expected to add another 9,000 parts. In five years, we hope to have one of the largest catalog offerings, spanning spine, extremities, trauma and sports medicine.

ORTHOKNOW: What have we not asked you, that we should have? What else would you like the industry to know about Tyber Medical?

Tyber: “What do you mean by rapid and cost efficient access?” The traditional development approaches take most companies 18 to 60 months and an expense of $200K to $800K per year to develop a new system, as well as the uncertainty of navigating FDA’s regulatory approval process. Our approach allows our customers to skip the standard development time and costs as well as eliminate any regulatory timeline risks.

It’s important that the industry knows that our interbody spacer portfolio covers nearly every possible geometrical and anatomical configuration, such as Lateral, Posterior, Oblique, Anterior, Transforaminal Lumbar and Cervical. This is important for our customers with special requests from surgeons for a specific size or shape. Typically this would require the company to file a special 510(k) or complete a risky letter to file. Our regulatory clearances cover the vast majority of these sizes.

We also have multiple tiered options within each product family to meet specific customers’ needs. Our TyPEEK titanium plasma sprayed interbody is geared towards companies seeking to stand out from other me-too players, while our sterile and non-sterile PEEK-OPTIMA spacers are geared more toward the cost-conscious customer. All of our systems utilize a standard instrument set to cut down on the capital costs.

Chief Executive Officer and President Jeff Tyber has served in the orthopaedic industry for 12 years in roles of product development, research and management at Aesculap Implant Systems, Extremity Medical and MedShape Solutions, the latter which he also co-founded.

Contact Jeff Tyber at jtyber@tybermed.com, and visit the company online at www.tybermedical.com.