Sector brochure: Medical
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Sector brochure: Medical

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While the recent economic climate has generally affected most market sectors, cutbacks at hospitals and other healthcare centres, new regulatory policies and changes ...

While the recent economic climate has generally affected most market sectors, cutbacks at hospitals and other healthcare centres, new regulatory policies and changes
to reimbursement strategies are having a particularly strong effect on companies in the medical device sector.

In parallel, there are growing babyboomer healthcare needs, a marked transition of
point of care towards the home environment and a variety of emerging markets to consider.

This combination of changing market and user characteristics and increasing cost and price pressures mean that the underlying demand for innovative products and solutions is only going to increase. This innovation will now, more than ever, also need to result in cost effective products that demonstrate higher levels of usability and health effectiveness.

With more than 25 years experience working with clients as an end-to-end product development partner, Sagentia is well placed to help medical device companies respond to the industry’s challenges. We focus on delivering innovative medical products in three key areas: point of care diagnostics, surgical devices and patient care.

We have delivered innovation and value to a wide range of clients including: Johnson & Johnson, AstraZeneca, St Jude Medical, T2 Biosystems, Titan, Prosurgics and Photocure.

Why Sagentia?
• Experts in complex medical device developments that meet aggressive timescales
• Accreditation to ISO 9001:2008 and ISO 13485:2003
• Deep science and technology expertise
• Multidisciplinary and cross sector teams providing broad insights
• Delivery of practical and commercial solutions that meet real user needs
• Global perspective and experience and worldwide delivery capability
• Customer friendly approach to IP

We understand the stringent needs of the highly regulated medical device environment
• ISO 13485:2003 certification and extensive industry expertise
• Compliance with international market regulations
• Product development leading to fully validated manufacturing processes
• Controlled DHF to support regulatory submissions
• Support or fully manage ancillary activities
• Device development spanning risk classifications from Class I to Class III
http://www.sagentia.com/medical

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Sector brochure: Medical Sector brochure: Medical Document Transcript

  • Medical Delivering value through complex product development
  • Medical MedicalMedical Recent projects Development with Patient care While the recent economic climate has generally affected most market St Jude Medical of a system sectors, cutbacks at hospitals and to transmit implantable other healthcare centres, new cardioverter-defibrillator (ICD) regulatory policies and changes data between patient and clinician. to reimbursement strategies Sagentia co-developed the transmitter, from initial are having a particularly specification through to transfer to manufacture, providing expertise in the selection of low-cost strong effect on companies products, consumer product design and electronics in the medical device sector. and software development. Design and development of a real-time Diagnostics In parallel, there are growing babyboomer healthcare needs, a marked transition of point of care towards the home environment PCR-based diagnostic unit . and a variety of emerging markets to consider. Sagentia developed the system and its high volume This combination of changing market and user consumable from initial thermal concept and modelling characteristics and increasing cost and price pressures through to transfer to manufacture. In order to meet clinical mean that the underlying demand for innovative products trial deadlines Sagentia supplemented its standard transfer and solutions is only going to increase. This innovation will to production activities with the manufacture and build now, more than ever, also need to result in cost effective of the first batch of systems. The system has successfully products that demonstrate higher levels of usability and completed clinical trials and was showcased at Medica in health effectiveness. November 2009. It is now being commercialised in countries including India, Brazil and Russia. With more than 25 years experience working with clients as an end-to-end product development partner, Sagentia is well placed to help medical device companies respond to A multi-award winning Surgical the industry’s challenges. We focus on delivering innovative medical products in three key areas: point of care diagnostics, robotic endoscope surgical devices and patient care. camera controller for We have delivered innovation and value to a wide range of clients including: Johnson & Johnson, laparoscopic surgical AstraZeneca, St Jude Medical, T2 Biosystems, procedures. Titan, Prosurgics and Photocure. Sagentia was involved throughout the design and development of the device for Prosurgics, a venture funded medical device company. Now with FDA and CE approval, Sagentia has more than 25 years the device has provided a range of benefits to surgeons including experience working with clients better image visualisation and reduced camera shake. It is also as an end-to-end product contributing to improved surgical efficiency through reduced development partner. operating times.
  • Surgical Diagnostics Technological advances in medical device instrumentation Due to cost and efficiency pressures, we are seeing a transitionAreas of expertise: and systems are changing the face of surgery. Increasing from ‘traditional’, largely immobile lab-based equipment to sophistication in sensing and intelligence, computer assistance portable devices in both the home and the hospital.• Single use instruments and robotics, and the relentless drive to miniaturise and• RF electrosurgical devices The global point of care diagnostics market continues to grow rapidly. optimise are making surgery truly minimally-invasive. This is resulting in devices needing to be smaller, faster and more cost• Robotics effective. As home use diagnostics also develop, human factors is becoming Meanwhile, surgical device companies are being pushed to demonstrate• High performance higher levels of safety and efficacy against a background of economic increasingly important. Combining product development with voice of surgical lighting and regulatory constraint. This is resulting in more complex product the customer research and user validation is crucial to ensure the final• Ophthalmic surgical development requirements and is also leading many companies to look product is fit for purpose. Areas of expertise: systems for growth in new and untapped markets. • Complex automated Whether there is a need to achieve cost reduction on an existing portfolio, Sagentia partners with surgical device and systems companies to tackle develop next generation products or address the opportunity presented instrumentation• Imaging systems complex, technically challenging product developments. We understand by the emerging markets, Sagentia is ideally placed to help clients. We • Handheld diagnostics devices the complex stakeholder, commercial and regulatory environments develop innovative and successful diagnostics products – from novel consumables through to complex systems integrated with simple user • Thermal & fluid flow modelling in which our clients operate. Our aim is to achieve robust, innovativesolutions in a responsive timeframe, and to ensure end products achieve a seamless transition to volume interfaces. • Microfluidic design withinproduction by early integration with your in-house or partner manufacturer. high volume consumables With a focus on delivering practical but commercially viable solutionsOf key importance, we are fully ISO accredited for medical development. Coupled to our links with clinicians, within demanding timescales, we work with both start ups and • Assay developmentteaching hospitals and academia, this presents a clear point of differentiation over non specialist consultancies. multinational companies to develop complex diagnostics products from front end innovation, through product design and development, to transfer to manufacture.Patient care T2 Biosystems case studyThe patient care sector, perhaps more than other areas Sagentia has been hired by T2 Biosystems to work on the development of its nextof the healthcare industry, is facing a dramatic period of generation of medical diagnostic products to improve medical care worldwide.change. The drive towards more cost effective and efficient T2 Biosystems’ proprietary technology combines nanotechnology and the miniaturisation of provenhealthcare provision is forcing device manufacturers to MR technology to develop rapid, accurate and portable diagnostics. T2 Biosystems’ underlying technologyprovide products which not only optimise patient outcomes has been validated in multiple published journal articles and has shown to accurately analyse viruses,but also provide greater value. bacteria, proteins, hormones, DNA, small molecules and other diagnostic targets. Diagnostics systems are typically restricted to the use of optics or the electrical signals that can be derived from an assay, whereasSagentia helps companies develop transformational medical technology T2 Biosystems’ technology uses magnetic resonance to quickly detect the presence of the assay’s targetthat helps to shape a new age of patient care. We specifically work with substances in extremely low concentrations.companies to develop products that treat acute and chronic conditionswithin the hospital, emergency, home or specialist environments. This Sagentia is working with T2 Biosystems towards the complete development of its benchtop instrument forincludes medical devices in the areas of critical care, patient monitoring, clinical trials and commercial release. We were chosen as the development partner due to our track recordalternate care and drug delivery. in running agile development projects that aim to bring new technologies and breakthrough products to market within short timescales. Developing this novel diagnostics platform technology offers improvedSagentia’s work can often start with front end innovation workshops speed, accuracy and efficiency as well as portability to a broader range ofthat help identify next generation transformational patient care devices. Areas of expertise: settings including doctors’ offices, homes and hospitals.Most of our work revolves around the application of science and technology • Patient monitoring devicesexpertise to help address fundamental health issues. Our core capabilitylies in the development of complex physical devices that are both • Renal careclinically and cost effective, from concept design through to prototype In helping us develop our diagnostic system, • Blood & fluid managementand transfer to manufacture. Sagentia’s team has showed that they are • Drug delivery devices willing to own the problem, ensuring that • Cell therapy & oncology our product development continues to meet aggressive timescales in preparation for our clinical trials. John McDonough, CEO, T2 Biosystems View slide
  • Sagentia’s ability to call upon a deep pool of scientific talent in-house has been a cornerstone of the company’s success. Why Sagentia? We understand the stringent needs of the highly • Experts in complex medical device developments that meet regulated medical device environment aggressive timescales • ISO 13485:2003 certification and extensive industry expertise • Accreditation to ISO 9001:2008 and ISO 13485:2003 • Compliance with international market regulations • Deep science and technology expertise • Product development leading to fully validated manufacturing processes • Multidisciplinary and cross sector teams providing broad insights • Controlled DHF to support regulatory submissions • Delivery of practical and commercial solutions that meet real user needs • Support or fully manage ancillary activities • Global perspective and experience and worldwide delivery capability • Device development spanning risk classifications from Class I to Class III • Customer friendly approach to IPWe work in partnership with our clients to add value at anystage of the innovation and product development process Front end needs and Concept generation and Technology and product Delivery and transfer market analysis technology invention development to manufacture re g rt ce n tu ce in o ct er tio en g g ot pp g ac n en du n m in rin tin t tio tio uc lig ng es ho su en uf g lig st to ro t to e ee in en n ou gi ed ca ra pl di an s ea te gi sis em n us es g en p di ty s m rs on y in lo sig st ci bl rin ili or pm s a tifi tr tio sc ue cr m & er m & ch c ly te ue m no ng on rin ag isi ab ct g t ar he os na g liv de ea y gy ss gy ou tu en ld n ys to em i lo in gy rd rin g id log us fa an ch se tv tio m fp st & tc se f t de ac ta lin lo lo ls ve ca id yp d up er te s & an te lie ep m ito sy ical em ile & no no as no re o de f o isa uc & uf ro or de ni ke el sf ds er ra ot e pp e m ht nc ta ta nt ns on an od od oo an ch ch ch ch se w st ic al ar ot tr st al ee t ll Hu Op Lig Da De Co Co Su Vo Fu Po Re Se Sy Sc Te Te Te Te Pr Pr Pr M M M M Tr IP N View slide
  • Sagentia Sagentia is a global innovation, technology and product development company. We provide outsourced R&D consultancy services to start ups through to global market leaders in the medical, industrial and consumer sectors. With global headquarters in Cambridge, UK, and US headquarters in Cambridge, Massachusetts, Sagentia works with clients from front end market needs analysis through to transfer to manufacture. We deliver innovation around new technologies and new generation products and services that provide commercial value and market advantage. The company also assists business leaders to create strategies for technology, innovation and growth. Sagentia Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK T. +44 1223 875200 Sagentia Inc | One Broadway | 14th Floor | Cambridge | MA 02142 | USA T. +1 617 401 3170 www.sagentia.com info@sagentia.comV1 1011 © Sagentia