stimOS
Medical Innovation with a Human-Centric Touch

Transparency in the current healthcare landscape is becoming an increasingly coveted and highly sought-after value. For instance, several practitioners from the non-profit Healthcare Information and Management Systems Society (H.I.M.S.S.) have documented patients actively seeking visibility into the clinical information associated with medical devices and services employed in therapeutic procedures. A trend such as this has been popularised due to the pressing need to stay informed about the variety of treatments and options one has at their disposal.

Reaffirming this thought process, Dietmar Schaffarczyk, a long-standing medical device auditing, and healthcare professional, personally believes that the patient has come of age today. “Gone are the days when patients solely trusted the opinion of their practising physician,” he says, expressing the idea of healthcare consumers wanting to form their viewpoints on what kind of medicines, vaccines, or even implants are best suited to them. Thus, ensuring complete transparency of all financial especially reimbursement possibilities medical processes, and safety and performance testing methods within a health system can help improve the overall patient experience. Schaffarczyk strongly emphasizes that all healthcare institutions ought to start practising the same with the utmost sense of urgency. Additionally, he also conveys the importance of enablement, where healthcare providers are expected to actively recognize, promote, and enhance a patient’s ability to manage their health and life better. With the right enablement, every party in the healthcare continuum, including pharmaceutical companies and device manufacturers, are thoroughly empowered to make informed opinions about the products they distribute, use, or purchase.

This quickly growing demand has created a gap in healthcare that only a few organizations anticipated and practised their art accordingly. stimOS, one of the pioneering, certified medical device manufacturers and research companies, focuses on advancing the effectiveness of implant materials for orthopaedic, dental, and craniomaxillofacial (C.M.F.) use cases with its innovative product: mimicking bone technology (MBT). “We want to be transparent in our efforts, enabling industry partners to benefit from this technology by applying it to their products and improving the health of each patient,” adds Schaffarczyk, who currently leads stimOS as its CEO and managing partner.

Pioneers of the SMART Implant

Established in 2015, stimOS develops the most advanced and intuitive technologies and procedures to refine, functionalize, and activate implant materials. Its flagship offering MBTosseo allows implants to become SMART and avoid infections or inflammatory reactions without the need for medication, significantly increasing the osseointegration properties of implant surfaces. It also excels at providing clients support in their product development and certification processes, showcasing its dedication to truly enabling each healthcare provider to deliver the best patient experience possible.

stimOS can offer such critical solutions and services due to its three founding pillars. The first is the staff’s exhaustive knowledge of the orthopaedic, dental, and C.M.F. markets that span decades.

The second pertains to “Regulatory Thinking” a comprehensive understanding of various national and international regulations, where Schaffarczyk and his team possess the discrete know how in medical technology to obtain quick approvals. And the many positive, promising results achieved through dedicated research in the biochemical activation of surfaces makes the third, allowing stimOS to build and offer unique products in this respective field.

The MBTosseo product, a biochemical covalently bonded surface activation layer, is quickly becoming a head-turner in the market today. This patented technology scores high on the safety and performance evidence level (S.P.E.L.) quality seal and provides a much needed solution to the challenges posed by titanium and polyether ether ketone (PEEK) implant materials.

Eliminating All Disadvantages

In Schaffarczyk’s vast experience, neither are all approved implant materials in the market ideal promotors of healing nor display the best anchorage within the body. “Metals can corrode and cause allergies, inflammatory reactions, and infections, whereas polymers are biologically inert,” he says. To elaborate, the titanium dioxide surface is highly osseointegrative, encouraging bone cells to take to the implant rather quickly. While this is very beneficial, the stiffness of metal proves extremely undesirable; titanium’s modulus of elasticity is greater than that of natural bone. Additionally, metals are not radiolucent. It becomes very complicated to observe bone healing with x-rays or C.T. scans because metal implants are reflective.

MBT is industrially scalable, applicable to all common orthopaedic, dental, and C.M.F. implants. It is available on-demand and nearly ‘price neutral’ compared to classical competitive coating technologies

On the other hand, PEEK implants are radiolucent, granting professionals seamless observation capabilities into new bone formation and healing. They are also much closer to the bone in terms of their modulus of elasticity. However, the material is completely bioinert: bone cells do not grow proactively over a polymer layer, often leading to implant loosening problems.

Having recognized these pressing issues, medical device manufacturers attempted to bring the best of both worlds together and counter the negative side effects: PEEK implants with a titanium surface coating. This combination, however, also brought out the worst properties of the two. Moreover, the titanium dioxide powder is plasma sprayed onto the polymer at temperatures upwards of 400 degrees Celsius while PEEK itself melts at 260 degrees. Even with a successful coating, the challenge of abrasion and delamination post operation has created waves of challenges for practitioners and patients alike.

stimOS overcomes all these hurdles with its ground breaking MBT offering, where the company utilizes calcium phosphate—a substance that exists within and combines with human bones in a gelatin matrix to eliminate abrasion, delamination, and implant loosening complications. All implants become SMART, as a “stealth cap” is placed over them, and a patient’s bone cells no longer recognize implants as foreign bodies but rather as “bone-identical” surfaces. “With MBT, implant loosening, inflammation, and reoperations are a thing of the past,” states a confident Schaffarczyk.

When applied to titanium, the company’s technology significantly increases an implant’s osseointegration properties while reducing corrosion. In the case of polymers, MBT preserves the good mechanical properties of the material and creates a bone identical implant surface, circumventing PEEK’s lack of bioactivity. “MBT is industrially scalable, applicable to all common orthopaedic, dental, and C.M.F. implants. It is available on-demand and nearly ‘price-neutral’ compared to classical competitive coating technologies,” adds Schaffarczyk. stimOS also leverages this innovation to develop solutions for spinal fusion surgery with its spineFuse MBT product line. A joint study with the Medical Innovations Incubator, Tübingen, using the example of MBTosseo’s spinal fusion implants, showed a considerable reduction in reoperations (Schaffarczyk et al., Indirect performance indicators a soften neglected criteria in decision making, MedDEV Quarterly, DOI: 10.5281/zenodo.4320352).

Advancing Medicine Towards Human Centricity

stimOS has strongly committed itself to the notions of transparency and enablement, placing humans—not as doctors, patients, and manufacturers, but as individuals themselves—at the heart of revolutionizing medical technology. According to the experts at stimOS, point of care (P.O.C.) technologies, patient-specific products (PSP), and smart implants are witnesses to this claim. With its products, the company intends to keep an eye on the various stakeholders in the arena from a human-centricity perspective, addressing the different and evolving needs of the market with comprehensive KPIs. “The transparency offensive of stimOS and the quality seal S.P.E.L. are aimed at competent authorities in regulatory affairs and approval,” explains Schaffarczyk, who has many years of experience as a medical device auditor and compliance expert.
With exceptional performance results of MBT, and the company’s in-depth knowledge of the many regulatory guidelines, stimOS brings to the market one of the safest implant material solutions and other related services. The company thus far has received only praises for the efficacy of its product delivery, where its benefits appeal to medical professionals and patients and insurance companies, reimbursement agencies, and hospital purchasing groups.

A monopoly on such robust technologies is far from the company’s vision; stimOS relies on industrial partnerships and intends to share the fruits of its labour with the rest of the market. This corporate mindset ties in with its human-centric approach towards propelling the future of implant material innovation. Moving forward, the company will continue researching and developing its MBTosseo product line, all while facilitating the approval of its partners’ offerings in terms of producing an equivalent device that conforms to the E.U.’s medical device directive or an FDA-approved predicate device for American markets. Lastly, stimOS is currently collaborating with AG PolyMORE a consortium of highly specialized polymer experts to combine their collective material know-how, surface expertise, and 3D printing capabilities to enable interested partners to provide the most advanced SMART implants fully customized solutions for users and patients across the globe.