Innokas Medical, with expertise dedicated to medical devices and software, and Biocodex PhaMe, providing pharmaceutical consultant services, have agreed on a strategic partnership. Through this collaboration and joint service offering, Innokas Medical and Biocodex PhaMe seek synergy effects and added value for companies developing drug-device combination products to the market.
A key trend transforming both healthcare and pharma sectors is digitalization. AI, i.e. Artificial Intelligence, machine learning and software, for example, will provide new opportunities for future patient care in both areas. The interest around digital medicine and combination products is expected to grow significantly, as digitalization offers new opportunities to combine devices with pharmaceuticals. According to Business Insider (2018), the global drug-device combination products market was valued at 81 billion dollars in 2017 and is projected to reach almost 140 billion dollars by 2025.
“On both device and drug field, digital transformation will have an impact on how diseases are prevented and how personalized patient care evolves in the future. We believe there is a huge potential in utilizing digitalization when integrating medical devices and pharmaceutical treatments”, ponders Tomi Haapanen, working as Business Development Director at Innokas Medical.
In future, it is more difficult to draw a distinctive line between medical devices and pharmaceuticals; companies are exploring the potential of developing combined products to the market. These combine products are, for example, medicinal products supported by a medical device or software as an integral part, medical device or software with an ancillary medicinal substance, medical device made of substances that are systemically absorbed, or something in between.
“In practice, it’s all about combining medical devices with drugs in some way. To mention a few examples, they can be AI-driven pre-filled autoinjectors, drug pills embedded with sensors, drug-coated contact lens or drug-eluding stents. There is a multitude of these combinations”, Haapanen tells.
Two intense regulatory pathways slow down the time-to-market - or does it?
Innokas Medical is a Finnish service partner in medical device design and development, contract manufacturing, quality management, and regulatory affairs. Biocodex Pharmaceutical and Medical Service Unit (PhaMe) provides a comprehensive range of pharmaceutical and medical services like auditing, regulatory and pharmacovigilance services, and is a part of multinational pharmaceutical company Biocodex Group.
“In addition to quality and regulatory consultancy related to pharmaceuticals, our customers usually seek for a knowledgeable co-creation partner for design and development of a medical device or software. Through the collaboration between Biocodex PhaMe and Innokas Medical, we’re therefore able to serve our customers with more a comprehensive service offering in future”, tells Jonas Hinkkanen, working as Head of Regulatory Affairs, Nordics and the Baltic, at Biocodex PhaMe.
”We wanted to meet the growing need of companies developing drug-device combination products by putting more focus on extending our joint services available for them”, he continues.
In both medical device and pharma sector, it is mandatory to comply with the quality standards and regulatory requirements. Requirements set by the authorities must be met to get certified end-products to the market. The aim is to ensure the safety and effectiveness of devices, technologies and solutions. The regulative scrutiny may bring challenges for companies working in the field – and for those, as well, aiming to enter the field.
”As an example, the new Medical Device Regulation (MDR) will introduce new classification rules for assessing combination products to the market. This brings new challenges on receiving CE marking, which is needed to indicate conformity with relevant EU-wide requirements. This is, of course, only one example – but at the same time, a very important one”, tells Pekka Pohjosaho, working as Head of QA&RA Services at Innokas Medical.
“It’s crucial to identify the specific requirements and the regulatory framework early on in order to build the conformance effectively along the development life cycle. This will speed up the time-to-market”, he continues.
Through the collaboration Innokas Medical and Biocodex PhaMe seek synergy effects and added value for companies developing regulated drug-device combination products to the market. Quality driven co-creation mindset as well as associated practices are the cornerstones of this collaboration.
”Through the collaboration, we’re able to launch a full-service offering for all areas of bringing regulated drug-device combination products to the market. We’re able to deliver the solution for our customers as a service or to complete their team with our experts. This enables both cost savings and more agile development cycles, as we’re able to avoid overlapping work by tackling two of the most intense regulatory pathways at the same time”, Haapanen explains and continues:
“We’re also able to complete our customers’ know-how by extending their competences with our scalable service center model including design and development, medical software and manufacturing expertise, allowing them to concentrate on their own core competences.”
For companies developing combination products it is a significant competitive advantage to be able to focus on their core competence while a network of professionals ensure that requirements for the domain are met.
For more information:
Tomi Haapanen | Business Development Director, Innokas Medical: firstname.lastname@example.org
Pekka Pohjosaho | Head of QA&RA Services, Innokas Medical: email@example.com
Jonas Hinkkanen | Head of Regulatory Affairs, Nordics and the Baltic Biocodex PhaMe: firstname.lastname@example.org
For more information about Innokas Medical:
Innokas Medical has produced medical technology development projects and products to leading international companies and Nordic growth and startup companies for over 25 years. The company’s service offering covers design and development, contract manufacturing and professional quality & regulatory services for medical devices. In addition to expertise dedicated to medical devices, together with their sister company Cubist IT AB in Sweden, they also help customers to develop their software as part of medical device, software as a medical device and data-driven healthcare solution – while taking all relevant requirements and the regulatory framework into account.
Innokas Medical has offices in the Oulu and Helsinki region in Finland, and in Estonia. The company’s annual revenues are M31€ and altogether 200 employees work at Innokas nowadays. Innokas Medical is part of Paree Group, a Finnish family-owned company, with a strong focus in international operations and continuous development. Read more about Innokas at: https://www.innokasmedical.fi/
For more information about Biocodex / Biocodex PhaMe:
Biocodex Nordics is acting as part of multinational pharmaceutical company Biocodex Group, founded in 1953 in France. When founded, the company’s initial focus was in gastroenterology but today Biocodex has transformed itself beyond its probiotic drug roots, expanding its portfolio into numerous therapeutic areas in more than 120 countries.
Biocodex’s Pharmaceutical and Medical Service unit, PhaMe, provides for companies a comprehensive range of pharmaceutical and medical services like auditing, regulatory and pharmacovigilance services. The unit operates in conjunction with Biocodex Nordics in all Nordics and Baltic countries, headquartered in Espoo, Finland. For more information, please go to: https://biocodexphame.fi/