Growing an ecosystem of suppliers for manufacturing world-class medical devices in India
Remidio’s Vice President for Operations, Wilson D’Souza, takes us through how Remidio over time has evolved from a single device manufacturer producing a high-quality product based on a core optical patent to a unique organization now having more than 5 different production lines producing world-class medical devices in diverse segments such as ophthalmology, in vitro diagnostics, and respiratory assist devices, over a 12-year period.
Remidio has significant in-house capability in taking a product from idea to market, thanks to a robust supply chain ecosystem, experienced Quality, Regulatory and production personnel, and an FDA GMP/ISO13485 certified manufacturing facility. Read on to know more about us.
From staring at a void to working with a full-fledged ecosystem of suppliers — How does Remidio partner to make it happen?
Remidio ambitiously started operations in 2009 to manufacture retinal imaging devices when lens suppliers mainly catered to the country’s elite scientific institutions. With the entrepreneurship culture still at its nascency, suppliers often turned down our request for want of volumes, or we would often not find suppliers meeting our requirements for precision and quality.
Remidio worked its way around by identifying similar-sized organizations dealing in lenses and mechanical parts and convinced them to partner with us. We assured our partners of all help in bringing in the required precision in their process through gages besides delivering the needed support on assessing raw material quality, in-process quality control, and critical tolerance assessments. We extended it ALL, be it design for manufacturing tolerance support, exploration of new manufacturing processes, or financial support in paying for failures in many cases. We adopted a similar approach for all our partners for different custom-designed parts and modules — be it on the optics side, mechanical side, or electronics side.
“Remidio’s inherited talent of identifying the right resources & engaging them in the right way has enhanced the product quality & service at Advanced Precision Engineering Company. We cherish & respect our partnership over the last many years with team Remidio. We also appreciate Remidio’s attitude of hearing out our suggestions & considering our inputs. We truly feel partnered with Remidio.” — Raju.M.V & Kaja.S, Managing Partners, Advanced Precision Engineering Company, Bangalore, India
Hence, today Remidio can deliver world-class medical devices with an ecosystem of partners that we can proudly say have grown along with us as an organization.
It is a general misconception that traditional suppliers in India cannot deliver world-class quality.
The suppliers Remidio approached at the outset were content/satisfied with one single large order and were unwilling to dream big or push boundaries. A convenient alternative to working on the much-required attitudinal shift was purchasing the materials from off-the-shelf product companies and being blind to the steep cost it comes along with — 10–25 times of the manufacturing cost!
Remidio’s challenging journey included -
· increasing the partners’ interest levels by getting them to view the big picture,
· assuring them about scalability in a niche market,
· finally convincing them to make world-class products locally
And then use this accumulated capability to make products and components for others globally.
The journey also involved Remidio bankrolling the initial investment made by our partners by offering open purchase contracts with more extended amortization periods. This approach positioned Remidio as a sought-after partner willing to co-invest and co-develop as well.
Remidio’s co-development approach — How does it work?
At Remidio, innovation lies at the core of our work philosophy, alongside the paradigm that change is the only constant. Hence, our medical devices do not undergo introduction, growth, maturity, and decline in the traditional product life cycle. Remidio’s product life cycle often ends just before it enters maturity.
We attempted to make a lightweight, portable device during one such key product evolution. When dealing with optical devices, a seemingly easy process tends to be complicated. We failed several times while co-developing the lightweight spare parts with our partners. We traveled to countries more advanced and experienced in high precision manufacturing — ahead of us in skills and technology, to understand if our vision for a high quality, portable, lightweight product was even remotely achievable. After gaining operational insights, Remidio returned to that one partner who exhibited a heightened interest in working alongside us to deliver on our self-imposed challenge.
“We have partnered with Remidio for a few years now, they are supplying us with a very important module for our product. The Remidio team is always very professional, cooperative, flexible and determined to help and to mitigate obstacles and difficulties. We highly appreciate the fruitful cooperation and looking for a long-term partnership between Visionix and Remidio.” —
Haggai Herman, COO at Visionix Ltd., Israel
And thus, Remidio filtered and arrived upon a pool of bankable partners over the years — in areas of optics development, optical coating, finish, multilayer PCB design, anodizing and surface finish, and finally complex submodule assembly. Furthermore, it is vital that the medical device comply with mandatory regulatory testing for safety requirements, for which the various risks are envisioned for compatible material to safety testing and usability the products. In all ensuring that world-class medical devices are produced and delivered.
Partners vs. Vendors — How does Remidio constantly and consistently differentiate between the two?
“Remidio has always looked for a partner willing to fail with us or be successful with us. An honest growth partner who enjoys the journey as much as the destination.”
Interestingly, few of Remidio’s product upgrades have been made possible because of the keen involvement of our partners. There is an instance of a partner who suggested design changes that helped bring down our cost per unit by 6% on Gross margin. At the same time, the partner benefited from reduced production time, leading to a win-win situation for both — a proactive approach by our partner.
The recent entrepreneurship boom in India across various segments, including medical devices, witnessed the entry of many suppliers into the market; Remidio was spoilt for options. Something unthinkable when we started out in 2009.
A year back, when the market conditions were slightly less conducive, a long-term partner proposed a solution to streamline the existing production process, which helped Remidio reduce its operational costs. Our partner intended to boost Remidio’s growth!
“This is the beauty of co-developing and partnering, not merely procuring from vendors. In the last 12 years of operation, I can say with pride that as Remidio grew, so have our partners.”
How to handle rapid growth with our partners — walk and work alongside.
When Remidio started in 2009, our products were well accepted in India and slowly found recognition globally.
We geared to get our facilities certified by international agencies and helped our partners upgrade their internal processes. Remidio extended the support of our in-house quality and regulation team to help our partners undergo a stringent auditing process. Today, Remidio is an ISO 13485 certified medical device company, and our products are CE marked and FDA 510(k) approved — and we have helped our supplier base become ISO9001 or other Quality Management System compliant and helped them inculcate a sense of process and quality in their manufacturing culture.
Was that all?
Internally, Remidio evolved to keep up with the market expectations and upgrade to newer technologies. We understand that technology obsolescence is inevitable. For instance, to take a product to the market quicker — the turnaround time (TAT) is saved by developing new technologies and exploration. For this, we have even adopted novel manufacturing techniques like 3D printing that allowed us the luxury of design changes in response to market feedback while continuing to meet safety and regulatory requirements. Moving from metal to plastic-based 3D additive manufacturing was not easy — we had to partner with our vendors to develop new finishing methodologies to achieve the same aesthetics and precision as seen on metal parts.
Diversify and de-risk strategy
As Remidio geographically expanded supply to 20+ countries worldwide, we also understood the bespoke regulations governing each country.
Simultaneously, we started working with suppliers from China, Taiwan, Singapore, and Germany. We reduced the risk of impacting our production due to the ongoing geopolitical shifts. We diversified our portfolio of partners even further. The diversification places an increased burden on our internal processes with the additional coordination, but that’s a risk we were willing to take — as it was something we could control internally.
Today, we receive high-quality lenses from our partners in India, Taiwan, Singapore, and the USA. We procure quality molds in Bangalore and Pune. Hong Kong and Taiwan are the other two destinations that provide an edge in Remidio getting the right plastic part molded while also investing in many custom lens designs.
“Today, Remidio has achieved an ecosystem of local and international partners delivering high-quality components designed to precise specifications.
What can Remidio offer today?
Today Remidio has a total of 15,000 Sq. ft. area FDA audited /ISO 13485 GMP facility for Contract Development and Manufacturing Services (CDMS) of medical devices. We have a robust in-house design and engineering team for optics, mechanics, electronics, software development, and artificial intelligence algorithm development. We also have a strong quality and regulatory team adhering to the ISO 13485 Quality Management System while meeting international standards (MDD/MDR/MDSAP) of global certifying bodies (CE/FDA/HSA/TGA).
Remidio today provides turnkey solutions spanning medical device design, development, regulatory approval, and manufacturing under QMS. We ensure that the products meet the requirements of MDI Europa and the US FDA when it comes to safety and quality. We take a product from concept to a finished device and, at the same time, take the device through regulatory compliances and certification and post-certification surveillance
All the process requirements are managed through a central portal from Bangalore, India. The significant ecosystem developed can easily supply the raw or finished material locally. To know more about us and our expertise, please drop by to watch a video of our facility and drop us a note at firstname.lastname@example.org