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

Best Applications of 3-D Printing in Medical Devices

The medical device industry is adopting 3-D printing for several applications. But what are the best uses for this type of technology today? The best 3-D printing medical device applications include external wearable devices, clinical study devices, and orthopedic implants.

External wearable devices are suited for 3-D printing because they are usually customized to fit each individual. This devices are attached to the outside of the patient and can be made much larger or thicker than surgical devices or implants. Biocompatibility requirements can be evaluated by ISO 10993-1. These devices fall within the “surface device” category with skin contact limited to unbreached skin. The amount of experimental testing needed depends on the biocompatibility information available for the materials used and the ones used in the fabrication processes. Initiatives like the Biocompatibility Consortium for Additive Manufacturing are underway to help create standards for assessing and validating 3-D printing processes.

Clinical study devices are suited for 3-D printing as well, where build quantities are low and design changes after evaluation are likely. “For a device with multiple components, 3-D printing offers a cost effective way to create clinically usable parts without the cost ($10,000–$30,000+) and development time (4–8+ weeks) of injection mold tools.”

Orthopedics and dental are another type of area where 3-D printing found excellent adoption.  A key performance aspect of orthopedic implants is fixation in the bone. The benefits with additive manufacturing are that the effective porosity and the thickness of the ingrowth area can be controlled throughout the build and the manufacturing completed all in one process.

References: http://www.mddionline.com/blog/devicetalk/top-3-medical-device-applications-3d-printing-05-01-15

3-D Printing Challenges and Opportunities in the Medical Device Industry

Although the medical device industry is already finding growing use for 3-D printing - prototyping and production of finished parts - there are still opportunities for improvement. In a Q&A with Ron Belknap, the president and CEO of ProtoCAM explained the most common 3-D printing mistakes, biggest opportunities and how the medical device industry can take the most out of the technology.

Ron Belknap advises that the most common similarity when things go poorly is lack of preparation: “When clients lack sufficient time, and insist on skipping right to part build, they increase the potential for failure and chance they’ll have to repeat the whole process. Ultimately, taking a very little extra bit of time up front can help guard against adding significant total time to project completion.”  When it comes to challenges, ProtoCAM’s CEO stated that the biggest ones are when companies wait too long before asking for help with their 3-D printed parts.

Regarding opportunities, Ron Belknap said that the biggest leverage is the ability to create parts that would be otherwise impossible with conventional manufacturing processes. “For example, with additive manufacturing, internal passages can be built directly into parts without regard for tool paths, parting lines, assembly, and so forth. This can significantly reduce number of parts, potential points of failure, and manual processes required to create parts.” The president and CEO of ProtoCAM also stated that going over the budget is not something they see very often: 3-D printing “generally has a very high ROI once risk avoidance, duplication of effort, and expedited time to market are factored in.”

Ron Belknap is clearly an enthusiast when it comes to 3-D printing: “A high-precision 3-D printed model will quickly prove a design, or uncover needed design corrections. This allows engineers to spend time on fine-tuning a validated design and avoid potentially wasting time on fine details only to have to replicate the effort after remedying core structural issues. Prototyping early helps guard against such project setbacks, expedites turning the designs over to production, and ultimately increases profitability by speeding time to market.”

References: http://www.qmed.com/mpmn/medtechpulse/how-get-most-out-3-d-printing%E2%80%94and-avoid-rotten-miracles

Reasons why 3D Printing Will Control the Medtech Industry

According to Rob Richards, business development manager for Orchid Design (Shelton, CT), which is part of Holt, MI–based orthopedic contract manufacturer Orchid, 3-D printing could soon catch on for manufacturing medical devices. Richards points out that, despite the arguments that one cannot achieve the economies of scale possible through more traditional manufacturing methods, several of devices are not manufactured in the same quantity as in traditional sectors. Besides, some of them exhibit a level of  complexity that would be much more expensive to manufacture through traditional techniques.

Several other  advantages of 3D printing were defended by Richard such as its capacity of being customized, precision and biocompatibility: “The internal geometries and structures are also enabling more biocompatible, porous materials that could allow orthopedic and other implanted devices to have enhanced properties such as promoting bone growth”.

Finally, Richards states that 3D printing is already getting more accurate, faster and cost is getting lower. “It’s only going to get faster and cheaper.”

References: http://www.qmed.com/mpmn/medtechpulse/6-reasons-3-d-printing-will-take-over-medtech?cid=sm.qmed.site.qmedsocial&hootPostID=50c7322d1c83622835b281ae1c99c51c

Rethinking 2014: Planning 2015

When rethinking about 2014, some consulting companies already have stats that show how the medtech industry performed last year.

Source: mddionline.com

            The results show a solid industry, with more than $380 billion worldwide sales, 5% sales growth rate and almost 10% of return on investment.

            As for 2015, the industry in the United States is still adjusting from the new tax on their medical device sales and the European sector is suffering from its internal pressure (see our last blog entry). So it seems like emerging markets are still an attractive type of investment: Asia represents more than one-sixth of the world’s medical device market and one should expect a double-digit growth in markets such as Mexico, Brazil and Malaysia thanks to increasing healthcare spending. “Expect more device companies to focus on these import-heavy markets, with Latin America and the Middle East as the most important growth sources for medical device manufacturers.”

References: http://www.mddionline.com/article/how-did-medtech-stack-2014-12-19-2014

http://www.mddionline.com/article/state-global-medtech-markets-12-19-2014

Important Key Points to Keep in Mind about Consumerisation Strategies

During the BIOMEDevice San Jose 2014, Andrew Atwell, principal at Samsung Open Innovation Center, stated his concerns about consumerization issues in the healthcare sector. According to him, there are four key trends that medical devices companies should keep in mind.

First of all, and following other sectors: free data. Not only gathering health information, but sharing it between devices. These data, however, must provide and  convert it into relevant actionable information. Another important fact pointed out by Andrew Atwell is the importance of releasing the information in real time. According to him, in medical labs there are still many paper-based results that are manually entered by a lab tech. “The doctors should be able to see the data immediately at a patient’s bedside or on the golf course,” Atwell said. Doing so, patients would properly follow protocols after leaving hospitals and it would prevent readmissions. The last concern stated by Atwell was about usability. “The traditional form factor of many medical devices has been frustrating for many users.” Both patients and doctors are demanding medical devices and systems that engage users.

References: http://www.qmed.com/mpmn/medtechpulse/4-consumerization-strategies-medtech-need-learn-fast

Brazilian Health Devices in MEDICA - Düsseldorf,GE

During November 12-15th, the renowned international event of the medical devices sector MEDICA took place in Düsseldorf, Germany. The Brazilian companies, under the Brazilian Health Devices - ABIMO’s project in partnership with APEX-Brasil - attended the event and the expectation for the next 12 months is US$ 16 million in business development as a result of the trade fair.

There were a total of 50 Brazilian exhibitors at MEDICA and the numbers are impressive: more than 3 thousand new contacts in more than 120 countries. As an instant result, MEDICA provided US$ 2.292 million in new business for the Brazilian companies.

References: http://www.abimo.org.br/modules/news/article.php?article_id=526

Brazilian Medical Industry Grows More than Expected

As opposed to what is likely to happen with most of the sectors, the Brazilian medical industry will grow more than initially proposed. Abimed (Brazilian Association of Medical Devices, Products and Supplies) corrected the estimated growth of this year, from 8% to 10%.

“The healthcare sector growth tends always to be higher than the GDP’s, since the population is aging and technologies brings innovations”, says Carlos Goulart, Abimed’s President.

Other statistics are also optimistics. The industry sales grew by 9.3%; the production by 5.7% and jobs creation grew by 3,7% during the period January - August/2014, when compared to the same period of 2013.

References: http://www1.folha.uol.com.br/colunas/mercadoaberto/2014/10/1536106-industria-medica-avanca-mais-do-que-o-esperado.shtml

Digital Health Funding is Accelerating beyond that of Traditional Healthcare

During USC's 2014 Body Computing Conference, experts agreed that digital health funding is accelerating beyond that of traditional healthcare. According to Rock Health (a company that provides startups with funding and full-service support), digital health is one of the fastest growing niches overall in venture funding today and is attracting investors from several different areas. Unexpectedly, it is surpassing medical devices in aggregate funding.

Casper de Clercq, a partner at Norwest Venture Partners, a leading investor in medical device firms, pointed to a trend in data collection. “There are other industries that are way ahead. Walmart, Target, Amazon, and Google know way more about our healthcare and our health situation than probably most of our providers do.” He mentioned the famous case of a Target store discovering that a customer was pregnant simply by monitoring her buying habits.   

Malay Gandhi, managing director of seed fund Rock Health, stated that large medical device companies are transforming their business models from a pure hardware business into a services business. “Technology enabled services in this category, where the medical device becomes a data acquisition mechanism, and you have software, analytics, and a services or patient management platform is really the future of medical devices.”

References: http://www.mddionline.com/article/venture-investment-digital-health-surpasses-medical-devices-141006

Risk and Challenges of Healthcare Systems Internationalization

Medical device manufacturers have identified “emerging markets” as their principal source of revenue growth in the coming years. However, during the last Economist’s Health Forum in Boston, major academics and industry’s players discussed the risks and challenges associated with rising demands in these countries.

The discussion explored a growing concern that the healthcare model in the United States and Europe isn’t sustainable or even necessary to meet the healthcare needs in many cultures. These nations will need to create a “more of an outpatient-oriented and prevention-oriented delivery system” that will require behavioral changes by physicians and patients.

“(...) replicating a hospital-based system in less-developed nations requires not only new infrastructure, but wholesale change in the behavior and practice of patients and physicians. (...) also demand a financial investment that even Western nations are having difficulty paying(...)” Peter Berman, a professor at Harvard University’s School of Public Health

Victor Joseph Dzau, MD, president of the Institute of Medicine brought an academic, clinical, and corporate perspective. He stated that every culture is different and needs specific solutions. “You won’t succeed unless you are really on the ground and really understand the culture”. Device companies must create local solutions to local problems in order to succeed.

References: http://www.mddionline.com/article/%E2%80%98globalization-not-americanization%E2%80%99-when-it-comes-healthcare-09-22-2014

Scenario of the Brazilian Medical Devices Market

MedTechWorld MD&M Brazil 2014, one of the main events of medical devices in Brazil, happened on August 26-27 at Transamérica Expo Center in Sao Paulo. This edition gathered together more than 3,000 professionals and 40 exhibitors.

One of the many interesting presentations was a study, conducted by Dr. Kleber Stelmasuk and Dr. Vitor Asseituno, both from Empreender Saúde, outlining the market scenario of research and development of medical devices in Brazil. The study revealed the strengths and weaknesses to enlarge the exports, increase the contact between university and industry for research and development, and identify what are the proposals to consolidate Brazil as a major global competitor of medical devices and nursing material. It also pointed out the concern about the deficit in the healthcare sector, since the industry doesn’t keep up with the patients’ demand.

References: http://www.empreendersaude.com.br/pesquisa-e-desenvolvimento-de-medical-devices-no-brasil-2014/

2014: So far, a great year for the MedTech Industry in the USA

      According to the MedTech Half-Year Review, issued by EPVantage, 2014 has been telling an optimistic story for the medical device sector.

     Some points of this report have to be mentioned: merger and acquisitions stands at US$27.2 billion, compared to US$19 billion of 2013. The report also notes that the value of M&A in 2013 was close to being the lowest in a decade. More merger and acquisitions are to be announced until the end of 2014/beginning of 2015. During the first six months of 2014, medtech venture capital investments stand at US$1.9 billion, less than half of the US$3.9 billion raised in all of 2013. But second quarter of venture capital investment was up 33% from the first quarter of the year, so the expectations are still high. FDA approvals are also moving very fast. For PMAs, the average review time was 18.4 months compared to the average of 35.9 months in 2013.

References:http://www.mddionline.com/article/5-points-showing-why-medtech-having-great-2014-so-far

Sales Increase in the Brazilian Medical Device Market

       Brazilian medical device sector is optimistic this year and companies expect sales to increase due to a growing demand boosted by the construction of new hospitals and labs, also because of the renovation of existing infrastructure.

      Regarding foreign firms, the Swedish manufacturer Sectra plans to replace the imports by a local production until 2016, by building its own factory or through a strategic partnership with a Brazilian manufacturer. The US-based Stryker, although it has no intention to produce medical equipment in Brazil yet, has an aggressive sales increase plan by exploiting other market segments with products made in the USA and Turkey. The company’s main concern is to recover the imports, which in 2013 fell by 15% because of the unfavorable exchange rate and inflation effects.

        As for the Brazilian companies, the expectation is optimistic as well. The surgical table-manufacturer Mecsul registers a sales increase of 20% each semester. 25% of Olsen’s production, medical and dental equipment manufacturer, is meant to the foreign market. Its medical line, for example, is sold in 50 countries. Over the past few years, Olsen’s foreign sales declined due to the competition with Chinese products, but the company expects this scenario to change.

References: http://www.abimo.org.br/modules/news/article.php?article_id=514

Crowdfunding: How to Raise Money Online

When it is time to raise capital, crowdfunding is not a usual way chosen by medtech companies. Especially because investors want to finance opportunities less risky which can bring faster return, like softwares, than some complex device that might take years to be approved by the FDA.

However, when a medtech company choses crowdfunding to raise money, it is important to know what can increase chances of success. GoGetFunding, a company that has helped people from all over the world to raise millions, names the best practices of raising money from online donors, for example, updating a company's Facebook status as daily marketing activity might ensure the crowdfunding. 

Some statistics are shown below:

 * Campaigns with day-to-day marketing plans raise 180% more;

 * Projects with an average word count of between 300 and 500 words raise the most money. Explain who, what and why;

 * Campaigns that have a personal video raise 105% more than those that don't. If a picture is worth a thousand words, than a video is worth a million.   

     Finally, GoGetFunding suggests 10 steps to use their statistics and raise money online:

1. Nurture relationships with your inner-circle of friends, family and extended networks,

       2. Evaluate how much you need to raise,

       3. Set a realistic deadline,

       4. Gather a small fundraising team,

       5. Have a marketing plan,

       6. Create an awesome, personal fundraising page,

       7. Launch!

       8. Reach out to your inner circle and then extended networks,

       9. Engage, update and thank,

       10. Success!

References:

http://www.mddionline.com/article/crowdfunding-best-practices-how-get-funded-

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