Making medical devices that customers want

Major challenges influence how the medtech industry works in term of product management, market positioning, and early-stage design and development. From downward cost pressures, reimbursement and regulatory requirements, increased competition, and, internal pressure to generate sales. As easy as it sounds, a customer-centric approach is a difficult thing to accomplish – but it helps medtech companies to think differently, engage with customers differently, and design and market devices differently. Here’re some tips on how adopt this strategy:

Source: MDDI

* Start with the Right Mindset: being a medical device company means that you are in the business of restoring and improving health. “Recognizing that will help you stay focused on making devices customers want and will buy.”

* Get Customer Input the Right Way: don’t just ask what features customers want in your product – ask what outcomes they want from using your product. “It is not the responsibility of customers to figure out what features will provide the experience they desire or achieve the result they want. What customers can meaningfully talk about is what experience and outcomes they want.”

* Minimum Viability, Maximum Value: “Put in just enough features so you validate that what you’re making is viable. Viable means the lean product sufficiently meets a customer need and will sell”.  In the medical sector, this could be harder due to regulatory approvals, reimbursement issues, and clinical trials. However, this is an attempt to minimize both investment and risk to avoid going to market with an expensive, feature-rich product that bombs. Maximum value is all about how much value your product can provide to customers.

         Despite significant barriers to successfully launch a product, this is an industry that exists to save lives – so companies should stay focused on the value, not product features.

Updates of Medical Device Regulatory System in 5 Major Markets

As the world does not agree on a harmonized medical device regulatory system, manufacturers face different scenarios in terms of market entry, registration requirements and compliance issues to be able to sell their products in foreign countries. Therefore, it’s important to monitor regulatory updates in major markets.

Brazil: ANVISA (Brazilian Health Surveillance Agency) has shown intentions to make market entry less burdensome—both externally for Brazilian market registrants and internally. Early this year, the government passed a new law, which allows ANVISA to do the following:

• Expand validity timeframes for some medical devices by up to 10 years.
• Accept quality management inspection reports conducted by other regulators.
• Expand certifications of laboratories authorized to conduct inspections and postmarket surveillance activities.
• Revamp requirements for registration transfers.

ANVISA must still develop its own regulations to take advantage of the new law. However, the regulator is now fully authorized to streamline the country’s device registration process. ANVISA has also extended its deadlines for technical requirement responses: registrants now have 120 days, rather than 90, to respond to ANVISA inquiries. Brazilian clinical testing rules for medical devices have also been harmonized more closely to those of international standards.

India: Although a comprehensive regulatory system has not yet been implemented, the Indian government has adopted significant actions to launch a more substantial medical device regulation. The government has proposed the creation of a new regulatory body, the National Medical Devices Authority (NMDA), a step towards a more strong regulatory system, which would provide transparency and predictability.

China: Despite recent initiatives towards a more structured and transparency to the registration process, China’s medical device regulatory system remains complicated and expensive. China Food and Drug Administration (CFDA) has formalized and clarified clinical trial requirements for medical devices and even established a process similar to FDA's substantial equivalence that can waive clinical trial requirements for qualifying devices. However, medical device registration fees have increased substantially in 2015. In many cases, it’s more expensive to bring a device to market in China than in the United States.

Japan:  The Pharmaceutical and Medical Device Law (PMDL), which replaced the country’s longstanding Pharmaceutical Affairs Law (PAL) last year, has impacted all aspects of the registration process. PMDL allows Japanese market registrants to utilize third-party certification from Registered Certification Bodies instead of Pharmaceutical and Medical Devices Agency (PMDA) reviews. There is also a new pre consultation program for manufacturers beginning their Japanese registration efforts.

South Korea: The Ministry for Food and Drug Safety (MFDS) has already introduced a new pathway that requires Korean Good Manufacturing Practice (KGMP) certification earlier in the registration process. MFDS has also suggested other changes to be implemented over the next months. The ministry is also planning to regulate in vitro diagnostic devices as medical devices rather than pharmaceutical products, which manufactures will have to ensure compliance under the South Korean Medical Device Act instead of the Pharmaceutical Affairs Act and comply with KGMP. Low-risk device market pathways in South Korea are also scheduled for reform.

References: http://www.mddionline.com/article/global-regulatory-update-2015-07-28-15

New EU Medical Device Regulations

In September 2012, the European Commission released a proposal for new European Medical Device Regulations (EMDR) intended to prevent public health scandal, such as the Poly Implant Prothèse breast implant in France. The final version of the EMDR is expected to be approved in late 2014 or early 2015. However, a more likely estimate is October 2015. The original proposal indicated that there would be a three-year transition period (from 2014 to 2017/2015 to 2018) for implementation of the new regulations.

The new regulation may increase costs and eliminate early access to device innovations that patients in Europe are used to experience. A survey made by the trade group Eucomed estimated the cost of the proposed regulations at €17.5 billion (US$24.3 million). European Union's current financial situation could force the European Council and Parliament to make major revisions to the proposed regulations reducing the cost of implementation.

The original proposal has suffered several modifications, but most significant changes include:

• The European Commission’s ability to create common technical specifications (CTS) will be expanded to all devices.
• Formatting of declarations of conformity and technical files will be revised.
• Manufacturers will be subject to unannounced audits by Notified Bodies.
• Spinal implants, devices that control and monitor active implants, nanomaterial, apheresis machines, and combination products will be reclassified as Class III devices requiring technical documentation known as a design dossier.
• Most in vitro diagnostics (IVDs) will require Notified Body involvement.
• A Unique Device Identification (UDI) system will be required for labeling, and the European Databank on Medical Devices (Eudamed) will be expanded.

References: http://www.mddionline.com/article/what-expect-new-eu-medical-device-regulations

Brazilian Health Surveillance Agency simplifies Import processes

Anvisa (Brazilian Health Surveillance Agency) is adopting actions in order to improve the import processes of healthcare products. RDC 15/2014 introduces significant changes to the Certificate of Good Manufacturing Practices and aims to help the new technologies’ registration in Brazil.

First significant change is to validate auditing reports made by third parties  (other regulatory agencies). Also, Anvisa will no longer emit certificates for lower risk products, as gloves, syringes and some surgical devices. Although this measure removes the need for inspection,  it does not change the criteria of effectiveness and security required. Finally, Brazilian Health Surveillance Agency will allow that the protocol of the certificate request is accepted to submit registration applications, maintenance and amendments of highest risk products. This means that a manufacturer will no longer need to wait  for grant of certificate to have an analysis of his products started. With the two processes happening concurrently, the time of arrival of new equipment in the market should be reduced.

References: http://saudeweb.com.br/42867/anvisa-simplifica-processo-de-importacao-de-produtos-de-saude/

Supply Chain Strategies for Medtech Companies

Before the senior director of the global supply chain at Edwards Lifesciences’ presentation at MD&M West 2014 Conference in Anaheim, CA, he talked about the theme of his session which was the best practices for medical device companies on supply chain strategies in the face of regulatory, technology, and margin-pressure challenges, as well as legislative changes.

     The senior director explained that innovation is and will always boost medical device companies. However, one shall notice that there is another key factor in the healthcare industry: operational and supply chain efficiencies, which is requiring transformational strategies for managing the supply chain. In addition, regulatory requirements are becoming more detailed and more constraining. At the same time, there are increasing margin pressures and legislative changes. All of these different factors are forcing companies to reevaluate their operations and supply chain strategies.

The senior director advises that innovation is not enough in the face of regulatory forces, legislative changes and margin pressures. In order to remain leaders in the medical device industry, companies should improve quality, lean manufacturing operations, distribution efficiencies, and inventory optimizations. Some areas to be focus on: global sales and operations planning platform, solid manufacturing improvement program (that includes lean manufacturing principles), determining how to introduce new products to the market and supplier risk management.

References: http://www.mddionline.com/article/supply-chain-strategies-challenging-medtech-landscape-0

Medical Device Firms and Its Challenges

As the medical device industry faces some significant market threats these days, like slow-growing market and strong regulatory system, it became necessary to be vigilant for signs and understand when changes are needed. Executives should pay attention to at least four signs that indicate that their companies need to adapt. Frost & Sullivan's Venkat Rajan, principal analyst, who leads the firm's analysis of the medical device sector, discusses what those are.

The first sign is “Utter Lack of Product Differentiation” which means that customers see medical device products as commodities and it leads to customers’ indifference to the product. The second sign is “Profit Model Under Pressure”, this means that the profit margin declines year by year and to assure its market presence companies are facing significant internal cost-cutting. The third sign is “Market Disruptors on the Horizon”, this sign has to do with fast technology development which means that a product becomes obsolete quickly and, sometimes, its substitute proves to be better, faster and cheaper. Finally, the fourth sign is “Internal Infrastructure Deteriorating”, this means that the company’s workforce usually is slow to adapt or innovate and its strategy normally is focused on maintaining its market presence instead of expansion.

References: http://www.mddionline.com/article/four-signs-medtech-firm-needs-reinvent-its-business-model

Medical Device Providers Adopting Sustainable Actions

As outsourcing seems to be a strategic measure that is getting more and more common worldwide, including when it comes to the medical device industry, suppliers are becoming an extension to the brand. So anything that the partner does, reflect on the company’s image and on the sales of end product. Hence, medical device manufacturers are asking suppliers to make their operations more sustainable.

There are several alternatives to become more socially responsible. Since adopting measures to take care of the environment such as plants, animals, air or water; to try making the office a better place to work. Unlike what one might think, that can help a company financially.  Some recycling or waste reduction projects  might decrease unnecessary expenses.

Earth Planet and the next generations appreciate these measures companies are adopting (or trying to)  today. Even if it is a marketing strategy or finance one, becoming socially responsible is aligned with society’s expectations.

References:http://www.mddionline.com/article/suppliers-make-sustainability-efforts

Meanwhile in the Brazilian Medical Device Industry

     Since Brazil has become one of the main destinies of many sectors worldwide, either because of its market size or its rising middle class, constantly monitoring what is happening inside its borders has become a routine task for foreign investors. The medical device industry is no exception, especially with such complex/bureaucratic regulatory system.

        However, this seems to be heading to a more harmonized system. A new Brazilian Good Manufacturing Practice (BGMP), RDC 16/2013, has gone into effect in the country. It means that two different BGMP resolutions (RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostic (IVD) devices) have been replaced by the new single one. The sector now only have one requirement to meet, hence, the BGMP has become less complicated. Companies now have 180 days to update their quality system and make it meet RDC 16/2013.    
       

        Another fact that has happened to the Brazilian medical device industry, and deserves both national and  foreign attention: in the end of last month (March, 2013) the Brazilian Medical Device Industry Association (ABIMO) has claimed, in Congress, the approval of a law that ensure tax isonomy between brazilian and imported products. Today, public and philanthropic hospitals have tax immunity when purchasing imported medical device.

“We do not want differential treatment. We are competitive. We export to more than 180 countries. Abimo’s proposal is simple: ensure tax immunity for all purchase orders made by institutions linked to SUS (Brazilian public healtcare system).”

Paulo Henrique Fraccaro, Abimo’s President            

        These two initiatives seem to be an effort to boost the national industry and make it more competitive. 

References: 

http://www.emergogroup.com/blog/2013/04/brazil-gmp-requirements-streamlined?utm_source=RADAR&utm_medium=newsletter&utm_content=Americas&utm_campaign=4April2013

http://www.valor.com.br/politica/3058980/industria-de-equipamentos-medicos-quer-isonomia-com-importados

Another Attempt to Globalize the Medical Device Industry

When it comes to a globalized economy, one obstacle always bothers the free trade: the regulatory systems of the countries. To stimulate the global economy and favor the free international trade, it is important to think of a way to converge rules and so, the free movement of goods will not become a slow bureaucratic process. As for a harmonized regulatory system for medical devices, the task is even harder because it also deals with national health laws.

This was the concern when in 1992 the European Union (EU), the United States, Canada, Japan and Australia gathered together to establish a method to harmonize the regulations on medical device. The voluntary group was called Global Harmonization Task Force (GHTF) and brought together representatives from medical device regulatory agencies and the regulated industry from its founding members.

Almost 20 years later, the new economic scenario called for new representatives. So, “to build on the strong foundation work of the GHTF and to accelerate international medical device regulatory harmonization and convergence”, the International Medical Device Regulators Forum (IMDRF) was conceived in February 2011, replacing the GHTF. Besides the original 5 founding members of the GHTF, it included Brazil to the discussion of future directions in forming an international harmonized and convergent regulatory system for medical devices.

The membership of China and Russia are currently being confirmed and the new Forum, including the 6 official members, China and the WHO (World Health Organization, an observer member), met in Ottawa in October 2011 to establish strategic topics for its operation.

Trying to standardize rules among the GHTF member countries was a big challenge, now with the creation of the IMDRF and new members added, the debate becomes even harder. Despite the adversity, the future results might turn out to be stronger and more creative once it takes into consideration different points of view. There is still a long way of hard work to build a harmonized and convergent regulatory system, which provides solutions to all the five countries and EU’s concerns. We hope the members create an environment of dialog to accelerate the harmonization and convergence of their regulatory systems, so that we could have a real “international medical device regulatory system”.

References: http://www.imdrf.org/

Medical Device Development: step-by-step

The development of medical devices requires rigorous regulatory requirements, careful planning and strategies for commercialization, pursuit for new technology and improvements.  While we see various commercially successful medical devices in the market, no comprehensive development model has been published.

Apart from the company size and the market they share, medical devices companies have a very similar strategy to develop and get their products to market. Scientific researches about medical device project and development process are very good references to the product development strategy of the companies and help them to improve and validated their models.

Stanford University’s researchers have studied the process of how medical technology is brought to market. The model developed by Researchers at the Stanford University Program in Biodesign divides the development in six phases:

“PREDEVELOPMENT, PHASE 0”

The clinical need must me identified and understood by the inventors and devices companies, this phase can be achieved, by direct observations, talking to patients or doctors. A large list of medical needs is made based on market size, clinical impact, and intellectual property.

“PHASE I: INITIATION, OPPORTUNITY AND RISK ANALYSIS”

When the need is identified, a review of all the perspectives is made. Market size, intellectual property, competitive structure, financial resources, regulatory requirements, likewise defining strategies.

“PHASE II: FORMULATION, CONCEPT AND FEASIBILTY”

Concept definition and feasibility take place in this phase, as well as strategies definitions. To accomplish the concept definition, both brainstorming sessions and 3D CAD occur. It is frequent to see the team’s marketing and the team’s R&D meeting with potential users (doctors, nurses, technicians, patients and others) to catch the clients’ attention. In addition, in Phase II we see the team of devices companies defining and analyzing the risks that can happen during the project.

“PHASE III: DESIGN AND DEVELOPMENT, VERIFICATION AND VALIDATION”

In this phase, the team creates a test to verify and validate the concept, although the tests only occur in Phase IV. These tests involve both engineering and quality tests. Many steps of this phase are conducted and reviewed by members of clinical regulatory departments, including FDA (in the USA). Likewise, the production of documentary records.

  

“PHASE IV: FINAL VALIDATION AND PRODUCT LAUNCH PREPARATION”

Final validation, final product design and regulatory approval take place in this part of the process that brings medical devices to market. Final product design must conform to ergonomics standards.  Quality system starts working to define, document and approve the business, which contains both product and administrative perspective.

“PHASE V: PRODUCT LAUNCH AND POST-LAUNCH ASSESSMENT”

Before the launch, doctors will have received training to use the new device. Once it has been approved that the medical device is successful, both launch and distribution will take place. With the new device been used widespread, literature and indications of use are made and approved by FDA (in the USA). R&D has a main role in this phase since the device requires continuing improvements.

         Stanford University Program in Biodesign research was based in more than 80 experts in the private and public sectors, including industry representatives and FDA officials.

         Biokyra follows its own product development process that is generically very similar to Stanford Model. Each country has its own regulatory system so that the product development process should adapt to those particularities.

          To develop a medical device is not an easy task but when it is done following a systematic method or model the process will be efficient, the results will be successfully accomplished and the market will have their needs met.

References: http://medicaldesign.com/mag/model_device_development_0908/