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Caterina Lucchini

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Medical devices in 2030

Caterina Lucchini
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Medical devices in 2030

Many challenges await medical device manufacturers in the next dozen years. As for drugs, the new paradigm is that of the value proposition. KPmg’s study tries to fix some point to look at Medical devices in 2030.

Reinvent, reposition, reconfigure

The pathway to success in 2030 for medical device companies, following a three-pronged strategy:

  • reinvent traditional business and operating models by integrating intelligence, delivering services beyond the device, and investing in enabling technology
  • reposition for the future competitive landscape, to adapt to challenges presented by new entrants, new technologies and new markets
  • reconfigure your position in the value chain of the future, by connecting directly with patients and consumers (B2C), vertically integrating (B2B) and/or transforming into `one-stop-shops’ for care.

Unbearable pressures disrupt the status quo

The medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly US$ 800 billion by 2030. These projections reflect increasing demand for innovative new devices (like wearables) and services (like health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets – particularly China and India. Medical device companies will ultimately seek to play a larger role in the value chain and get closer to customers, patients and consumers. Done right, this will not only add new revenue streams for them, but also contribute to shorter, cheaper, and fewer hospital visits – and thus lower healthcare costs. Finally, the industry have to shift the focus from cost to value.

 

Swiss Healthcare and Pharmaceutical Market

Caterina Lucchini
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Swiss Healthcare and Pharmaceutical Market

Interpharma recently pubblished a report on Swiss Healthcare and Pharmaceutical Market.

In 2016, the pharmaceuticals market in Switzerland grew 4.6% over the previous year to around 5.6 billion francs. In 2015, a slightly higher growth was recorded.

The growth is due in particular to the launch of new and innovative medicines – especially for cancer, but also for multiple sclerosis. Together with certain antiviral medicines, the growth achieved by this group of products accounted for around half of the entire market growth.

Indication area

In 2016, medicines for diseases of the central nervous system had the biggest market share at 15.6%. This category includes analgesics, medicines for diseases such as epilepsy and Parkinson’s and also treatments of mental disorders (hallucinations, delusions and depression). Analgesics formed the biggest group in this category.

The next biggest market share was achieved by cancer medicines (13.9%) and treatments for infectious diseases (11.4%). The former include classical cytostatic agents, which are used in chemotherapy, so-called monoclonal antibodies, which are used alone or in combination with chemotherapy, and also various other products used in cancer therapy. The latter consists of medicines to treat hepatitis C and HIV or antibiotics. Vaccines also fall into this category.

Generics market

Reimbursable generics achieved sales of 699 million Swiss francs in 2017. Compared with the previous year, the growth amounted to 4.8%. In terms of volume, generics showed a 0.6% increase. The value of the generics market has more than doubled since 2005.

Pharmaceutical industry crucial in national research and development

Private industry continues to invest a great deal. In 2015, the private sector accounted for more than 63% of all investments spent. The public sector (federal government and cantons) contributed 24% of research and development (R&D) funding, while around 2% came from private non-profit organizations and from universities.

R&D play an important part in Switzerland’s private sector. In-house R&D spending in 2015 amounted to 15.7 billion Swiss francs. This expenditure covers all financial and human resources deployed for R&D within companies in Switzerland (production sites or laboratories). At 5.5 billion francs, the pharmaceutical industry accounted for around 35% of all in-house R&D spending in Switzerland, which was thus around three times as high as the amount spent in the engineering and metal industry.

Many corporate groups are increasingly focusing their R&D spending on individual company units, while other divisions apply the results of their R&D. If this is included in the analysis, the pharmaceutical sector benefited from more than 7.9 billion francs or 51% of total in-house R&D spending in 2015.

MyStudies App from FDA

Caterina Lucchini
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MyStudies App from FDA

The U.S. Food and Drug Administration (FDA) is posting computer code and a technical roadmap that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app.

What MyStudies App is

The App is designed to facilitate the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries.

The storage system can be reconfigured by organizations conducting clinical research.  The app bore the FDA brand while its functionality was tested in a pilot study, but it can now be rebranded by researchers and developers who would like to customize and rebrand the app.

FDA MyStudies App important features

  • The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight
  • The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users
  • The data storage environment is partitioned to support multi-site trials or “distributed database” studies
  • The code for MyStudies will be open source so software developers can improve upon its capabilities

Real world data

Real world data are assuming an increasingly central role within the care system, as they can:

  • optimize the organization of health systems and the provision of services
  • capture and process the actual data on the use of drugs among the general population.

Precisely to this last area, the possible use of real world data is also used to conduct clinical studies with less or not selected patients’ cohorts compared to traditional designs of randomized trials.

Blockchain technology in the pharmaceutical logistics industry

Caterina Lucchini
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Blockchain technology in the pharmaceutical logistics industry

“The potential of blockchain technology in the pharmaceutical logistics industry is significant; however, the transition to the effective adoption of these new solutions will require further technological development and the willingness to collaborate on the part of all the actors involved”, explains Pina Putzulu, marketing and innovation director for DHL Supply Chain.

To achieve this goal, the company has been investing and working at a global and local level for more than five years to implement technologies and processes that are essential enablers for the development of blockchain technologies.

Strengthening the fight against counterfeiting

In Italy we anticipated the entry into force of the Delegated Regulation 2016/161 of the European Commission. “We adopt a solution that, through vision technology, allows real-time decoding of  monodimensional and two-dimensional barcodes on the pharmaceutical packaging, noting in particular AIC and serial number of each package” adds Putzulu.

The advantages of this type of technology for the pharmaceutical industry are many:

  • automation of the serialization process
  • real time verification (with warning on any discrepancy) of product code, quantity, batch and expiry
  • tracking of the serial code sent for each order to each recipient
  • availability of digital images, as evidence of the content of the order.

The serialization project in Turkey

In Turkey, the first country to have developed a traceability system, DHL Supply Chain has already been present since 2010 with a serialization project aimed at helping the country to reduce health spending. The “Serial track and trace” project involves over 34 thousand actors in the supply chain and makes it possible to check that the packaging of drugs can not be sold more than once, also preventing the falsification of the bar code. “To this end, the notifications received from the supplier, the pharmaceutical warehouse and pharmacies are used, as well as the approval to the sale received from the institutions responsible for the reimbursement of health expenses. For example, if the database has not received the serial number of that product and the pharmacy is trying to dispense it, the system warns the pharmacist that the product can not be administered, because there is a problem linked to identification”, explains DHL Supply Chain’s innovation manager.

End-to-end traceability

Serialization, traceability and anti-counterfeiting have been a priority action for DHL for almost ten years, which is now deeply committed worldwide to provide a proactive response to the demand for an end-to-end traceability system and effective support harmonization of regulations on drug serialization in the EU.

In particular, by February 9, 2019, pharmaceutical companies wishing to sell their products in European Union countries, with the exception of Italy, Greece and Belgium, will have to implement Directive 2011/62 EU. To counteract falsification and increase traceability, serialization requires that the manufacturer code, product code, serial number, lot number and expiration date are indicated on the box of each prescription drug. This information must be generated at the time of production of the drug and verified before dispensation to the patient.

“In order to support the pharmaceutical industry to implement the directive and satisfy every other need for serialization, DHL Supply Chain has focused on developing a unique software and operating solution globally. To give a few numbers, almost 100 customers are involved in Europe, ten nations and 17 sites for the storage and distribution of drugs that will be implemented. Thanks to the technologically advanced support, our service is evolving towards the protection of public health both in terms of protection and safety of the pharmaceutical product, and control and monitoring of the entire supply chain”, says Putzulu.

 

The Italian Group’s proposals for antimicrobial stewardship to counteract antibiotic resistance

Caterina Lucchini
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The Italian Group’s proposals for antimicrobial stewardship to counteract antibiotic resistance

The Italian group for antimicrobial stewardship (Gisa) puts forward some proposals to improve the use of antibiotics, in order to:

favor access to those of new formulation

decrease inappropriate use

reduce the risk of infectious patients in the hospital.

This can happen starting from a greater attention to good welfare practices, from the need to promote vaccinations among adults, those at risk and among hospital operators, from the strengthening of microbiology services and from a strong involvement of hospital pharmacists.

Italian data

Each year there are 450,000 to 700,000 cases of hospital infections. Infections affect from 5% to 8% of hospitalized patients, especially those assisted in intensive care. In 1% of cases these infections are fatal with about 7 thousand deaths per year. The economic impact of the phenomenon can be estimated at around € 1 billion a year, a figure that weighs on the health budget and is therefore subtracted from preventive measures and resources for the correct use of new antibiotics.

Actions needed

Many cases of complications and deaths could be avoided by putting into practice simple rules of hygiene, rapid diagnosis, facilitated and regulated access to new antibiotics (with the fight against the abuse of existing ones) and vaccines.

“Today the new antibiotics are not considered, strictly speaking, innovative drugs, as they represent an evolution of already existing drugs. They therefore do not enjoy routes that favor quick and easy access and do not have the allocation of dedicated resources – says Francesco Menichetti, president of Gisa. – The need to access these new drugs requires a revision of the rules (AIFA, prescription restriction) that does not go towards a senseless liberalization but considers procedures that allow clearly defined areas of potential utility, rapid access by specialists who treat patients with serious infections, for whom such drugs could be a life-saver”.

Support research on new antibiotics

The development of new antibiotics has opened new therapeutic possibilities. The ability of bacteria to develop mechanisms of resistance even against newborn molecules, however, requires a multidisciplinary, multiform and multi-institutional approach.

“For this reason – concludes Menichetti – to effectively combat these species of ‘intelligent microorganisms’ is necessary not only research, but also and above all strategies to control the infections, surveillance, good use of antibiotics in hospitals and local areas, training, education of health workers and citizens also through new means of communication and the involvement of the institutions”.

Regulatory science strategy to 2025, open consultations

Caterina Lucchini
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Regulatory science strategy to 2025, open consultations

Ema started on December the open consultations on Regulatory Science strategy to 2025. “This document aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines development that we together with the Commission and NCAs experts have identified in a thorough process of mapping and selection. Now we want to hear from our stakeholders whether they consider this strategy is ambitious enough”.

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.

The chapters of this guide include:

Human medicines – five strategic goals for regulatory science

“To underpin its mission of protecting human health, EMA must catalyse and enable
regulatory science and innovation to be translated into patient access to medicines
in evolving healthcare systems.”

  1. Catalysing the integration of science and technology in medicines development
  2. Driving collaborative evidence generation – improving the scientific quality of
    evaluations
  3. Advancing patient-centred access to medicines in partnership with
    healthcare systems
  4. Addressing emerging health threats and availability/therapeutic challenges
  5. Enabling and leveraging research and innovation in regulatory science

Veterinary medicines – four strategic goals for regulatory science

“To foster scientific excellence in the regulation of veterinary medicines for the benefit
of animal and public health while facilitating and promoting innovation and access to
novel medicinal products.”

  1. Catalysing the integration of science and technology in medicines development
  2. Driving collaborative evidence generation – improving the scientific quality
    of evaluations
  3. Addressing emerging health threats and availability/therapeutic challenges
  4. Enabling and leveraging research and innovation in regulatory science

Looking for philosopher’s stone

Caterina Lucchini
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Looking for philosopher’s stone

Next generation biotech could allow 200 years to live in the coming years. Based on Kris Verburgh, medical doctor interested in preventative medicine and aging and author of The Longevity Code “In the near future, we will see a new biotech age unfolding, in which our health, bodies and lifespan will drastically change”.

“People – explains the Belgian researcher – want to survive: it is an evolutionary instinct, in fact. I think that many would be interested in lengthening their lives, provided they can still enjoy it, that they remain healthy and ideally young as well ». And the search for senolithic drugs, which slow down the processes of cellular senescence to delay the appearance of diseases typical of the elderly, is precisely the direction towards which many laboratories are being directed to. The European Commission is investing resources in research and innovation projects dedicated to the management of aging.

Is it really the future we want?

“What I have understood in the end is that the future [as understood by the transhumanists NdR] does not exist or exists only as a hallucinatory simulacrum of the present, a comforting fable, or a terrifying horror story that we tell ourselves to justify or condemn the world in which we live, the world built around us, moved by our desires, in spite of our reasonableness”.

3D‐Printed Gastric Resident Electronics

Caterina Lucchini
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3D‐Printed Gastric Resident Electronics

MIT researchers pubblished recently ad article explaining their solution for the development of new controlled and prolonged release modes in the stomach: a smart capsule printed in 3D, able to communicate with the outside by Bluetooth.

The research of Kong and collegues has been pubblieshed on Advanced Materials Technologies. The project involves students, technicians,  engineers, and clinician from the MIT, Brigham and Women’s Hospital, Charles Stark Draper Laboratory, Boston University School of Medicine and the University of Utah. Students from the University of Utah who are involved in the completion of the project are graduate student Palal Ghosh, who is a co-author of the paper, and an undergraduate student Hakimi Nazlie.

3D gastric resident electronic (GRE) concepts

GRE is designed to be delivered orally, reside in the stomach for weeks, and finally break up, pass through the pylorus and be excreted from the gastric space.

Specifically, the GRE can be compressed into a capsule‐size dosage form. The expansion of the device enables gastric residence and allows long‐term remote communication with personal device. Ultimately, the disintegration of the device allows the safe passage of the device from the gastric space. GRE is directly compatible with personal devices, such as a smart phone, empowering the users to communicate and control the long‐residence device without a specialized equipment. This enables a seamless interconnection with other wireless electronics peripherals, wearable devices, and biomedical implants, allowing a real‐time feedback‐based automated treatment or responsive medication.

Applications

The possible applications identified by its inventors include the possibility of identifying infections, allergies or other organic events, and releasing the necessary drug. The capsule is today powered by a small battery,  but could evolve in the future towards more innovative and efficient versions that could use, for example, the acidic environment of the stomach for the production of energy necessary for its operation. New sensors are also being studied, which will widen the range of possible applications such as to obtain different times of gastric permanence, or to treat highly immunosuppressed and high-risk patients, who could thus be monitored to immediately identify the onset of an infection.

Door-to-door distribution channel for supplements market

Caterina Lucchini
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Door-to-door distribution channel for supplements market

The direct door-to-door selling channel for supplements seems to grow. This data arrived from the Italian Integrators – AIIPA (New Line Market Research data) and AVEDISCO.

Distribution channel analysis

Chemistry represents over 80% of the value of the entire purchased in absolute terms, but the growth rate is decreasing.

The growth rate of the GDO is more dynamic with an increase in turnover from 237 million euros in 2017 to 256 million euros in 2018.

The volume of Associate Companies involved in the door-to-door sales segment grew 16.8% in 2017 compared to the same period of 2016 and recorded a turnover of more than 425 million.

The preferred food supplements in the different distribution channels

Probiotics and mineral salts are the two most requested categories of supplements in pharmacies and parapharmacies: specifically, probiotics represent 13% of the total in pharmacies. In the GDO, however, the most purchased are the mineral salts, which compared to the same period of 2017, have recorded a growth of 20.3% and alone account for 12.5% of total supplements.

In Direct Sales, the most popular category of supplements are multivitamins, followed by Omega 3.

Data is the new oil

Caterina Lucchini
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Data is the new oil

IDC predicts that the Global Datasphere will grow from 175 Zettabytes by 2025.

IDC has defined three primary locations where digitization is happening and where digital
content is created:

  • the core (traditional and cloud datacenters)
  • the edge (enterprise-hardened infrastructure like cell towers and branch offices)
  • the endpoints (PCs, smart phones, and IoT devices)

The summation of all this data, whether it is created, captured, or replicated, is called the
Global Datasphere, and it is experiencing tremendous growth.

By 2025 connected users will be 75% of the world’s population – children, elderly and emerging market citizens included – hurry up to understand how strategic the development of technologies (such as 5G) can increase so more secure connectivity and accessibility of data from portable devices in real time.

Will the bolckchain really protect us?

The explosion of the dimension of the Datasphere implies an unprecedented vulnerability of the information. The blockchain – synonymous with decentralization, transparency, security and immutability – could be the technology to bet on, because it provides a secure architecture for data exchange and sharing, leaving information to its legitimate owners.

How much are our data worth?

And here comes the beauty! Because if the individual becomes aware of the value of their data, it acquires a huge bargaining power. For now, in fact, consumers provide their personal data very easily, but, as Steve Jobs said, “If the service is free, the product is you” and this people have started to understand it and the companies as well, running to repair, and in fact starting the trade in personal data, which probably will be based on cryptocurrencies. How fair this trade can be is easy to guess: the individual will not be able to win or even just draw the tough challenge against the multinationals!
What is configured is really a future in which “data is the new oil” and where it will be necessary to gear up to avoid being overwhelmed – at all levels – by this impetuous avalanche.

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