Get the Most out of Your Medical Device Contract Manufacturer

Contract manufacturing is a term that has been around for decades in the medical device industry. However, medtech companies are increasingly calling these service providers to assume more responsibilities, including design and development. Whether because of pricing pressures, government regulations, or rapidly evolving manufacturing techniques, manufacturers are offering a wider menu and forming business partnerships with medical device companies.

However, every type of outsourcing has its difficulties. There are some tricks to get the most out of it, though.

1. Clearly define roles, responsibilities, and expectations: “For example, what kind of support is the contract manufacturer willing to provide in the early stages? Who will assemble the prototype within each phase? Who will do the testing?”

2. Constant vigilance will minimize surprises: “A lack of communication will inevitably lead to nasty surprises, but “over communicating”—too many e-mails or too many meetings—can negatively affect productivity.”

3. Truly understand the level of each partner’s expertise: “Hope for the best, but plan for the worst.”

4. Fool me once…: “Learn from past mistakes, which often are due to putting off “trivial” issues early on in the process that then turn into much larger problems later on.”

If you are having issues with your medical device contract manufacturer; you are interested in arranging a business partnership or curious to learn more about medical device contract manufacturing, drop us a line! Biokyra is a Biomedical Engineering Company that develops minimally invasive medical devices, from the idea/need to the pre-series production. Our goal is to make your idea become an innovative and successful product. Therefore, we provide feasibility analysis, materials research, validation tests, and many other services.

References: http://www.qmed.com/mpmn/medtechpulse/outsourcing-medical-product-development-right-way

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

Stratasys’ Objet260 Dental Selection 3D Printer

During the last International Dental Show in Cologne, Germany, Stratasys showcased the Objet260 Dental Selection 3D Printer. The multi-material printer targets mid/large sized dental and orthodontic labs that are trying to increase their market share.

            

According to Avi Cohen, the Director of Global Dental at Stratasys, “With the introduction of the Objet260 Dental Selection, Stratasys is closing the loop in digital dentistry by providing a 3D printer that can take the color digital file resulting from the intra-oral scanner and transform it into a color, multi-texture dental model. This directly contributes to better accuracy for the dental practitioners and better understanding for the patients.  For any dental or orthodontic lab looking for a competitive edge today and tomorrow, the Objet260 Dental Selection should be at the top of their list.”

The printer works with PolyJet dental materials that reduce equipment expenses and allow the creation of a great range of applications, including “implant testing with stone models that replicate the textures and look of gingiva for functional evaluations”. Also, labs can print clinical “guides directly with HD renderings of tooth, root, and nerve-canal anatomy color coded to illustrate different dental procedures.”

References: http://www.notey.com/external/3795481/3d-printing-hyper-real-teeth-mouths-gums-with-the-new-objet-260-dental-selection-printer-technology-3d-printing-3d-scanning-3d-software-3d-scanners.html

Brazilian technology on the cutting edge of Endovascular Disease Treatments

In consonance with current trends in endovascular devices technology, as can be seen by the big companies’ moves, Biokyra is working on two products that may enhance the performance and ease the treatment of aortic aneurysms. The Endovascular Suture is a system capable of performing sutures by minimally invasive technique. An innovative tool to the surgeon, opening new possibilities to endovascular surgery and possibly also to other surgery specialities. This is a worldwide innovative product that represents an evolution in minimally invasive procedures. Click here to watch the video.

The company is also developing the Thoracoabdominal Aneurysm Treatment Stent Graft System: designed to provide an off-the-shelf solution for the treatment of thoracoabdominal aneurysms (TAAA), while used in combination with other standard commercially available devices. This hub endoprosthesis avoids the need for custom designed devices for the treatment of branched portions of the aorta and make the treatment available to more patients. You can watch the video here.

Biokyra is always looking for business opportunities and funding. If you have an idea for a medical device or if you are an investor who is interested in getting involved, contact us.

Medtronic investing in the Endovascular Business

It seems like Medtronic is interested to continue investing in aortic and peripheral vascular business, since it has been among its fastest-growing divisions for the past five years. The company has already disclosed an investment in Arsenal AAA, a subsidiary of Arsenal Medical - which develops technology to avoid complications linked to endovascular aneurysm repair (EVAR) procedures.

A few days after the announcement of this investment, Medtronic revealed its acquisition of Aptus Endosystems – maker of two FDA-cleared fastening devices and a steerable catheter for delivery of peripheral vascular products, which Medtronic will distribute. This statement was made during the Society for Vascular Surgery’s annual meeting.

    In a press release, the company said that these two investments were “demonstrations of Medtronic’s’ commitment to leadership in the Aortic space.” According to ReportsnReports.com, the market for aortic stent grafts is expected to increase at a compound annual growth rate of 6.7% until 2020, when it is expected to reach $1.9 billion. The market research company still states  “Despite the high product price, physicians still see a significant benefit in providing endovascular options ahead of performing open surgery”.

References:

http://www.mddionline.com/article/medtronic-moves-advance-aortic-business-06-19-15